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Introduction

Background

Inflammatory bowel disease (IBD) is a chronic, immune-mediated inflammatory condition of the gastrointestinal tract, comprising ulcerative colitis, Crohn disease, and unclassified types []. The global prevalence of IBD has been rising [], which results in notable economic and health care burdens []. With enhanced diagnostic capabilities and rapid urbanization, the incidence of IBD has significantly risen in China, making it the country with the highest prevalence in Asia []. By 2025, the number of individuals affected by IBD could reach 1.5 million in China []. The highest incidence of IBD is among adolescents and young adults [].

Currently, IBD is a lifelong condition with no definitive cure. Manifestations such as repeated diarrhea, fecal blood, stomach ache, and severe tiredness greatly affect the life quality of adolescents and young adults [], with self-management behaviors being crucial in enhancing life quality and disease prognosis []. Self-management behaviors encompass patient actions aimed at sustaining and enhancing their health via various self-guided actions, covering areas such as medical, emotional, and role management [].

The adolescent and young adult phase represents a critical transition from childhood to adulthood, characterized by substantial physiological and social role transformations []. Young individuals with IBD encounter dual challenges: managing their medical condition while adapting to social role changes []. Consequently, researchers have highlighted that self-management behaviors of adolescents and young adults with IBD need to be improved [-]. Therefore, effective interventions are urgently needed to enhance self-management behaviors in this population.

However, existing interventions for adolescents and young adults with IBD often concentrate on isolated aspects of self-management and demonstrate considerable heterogeneity in results []. Moreover, these interventions [], which are typically led by psychologists, do not align with China’s clinical practice. In China, clinical nurses primarily assume responsibility for patient self-management. Consequently, it is critically important to develop an all-encompassing and effective program for self-management behaviors of adolescents and young adults with IBD, particularly within a nurse-led clinical environment.

The formation and sustainability of self-management behaviors are underpinned by underlying motivational mechanisms. The self-determination theory [] serves as a pivotal framework in behavioral studies, playing a crucial role in predictive model construction and intervention design []. This theory highlights that fulfilling basic psychological needs (competence, autonomy, and relatedness) is indispensable for fostering motivation and sustaining behaviors [].

Based on the self-determination theory, our research team conducted a preliminary study [] on the influencing factors of self-management behaviors in adolescents and young adults with IBD. The study [] revealed that perceived social support would influence self-management behaviors through the mediating effects of basic psychological needs and emotional issues, indicating that enhancing perceived social support, satisfying basic psychological needs, and alleviating emotional issues were crucial for improving self-management behaviors. To identify effective strategies for these improvements, we conducted a systematic review of evidence [] in self-management interventions for this population. The review found that multicomponent interventions were the most effective approach. Health education was necessary to increase knowledge and satisfy the need for competence; peer support could significantly enhance perceived social support and satisfy the need for relatedness; group-based mindfulness training could effectively relieve emotional problems; and remote interventions were shown to improve adherence to intervention among adolescents and young adults. In addition, solution-focused intervention [], which complements self-determination theory by addressing the basic psychological needs [], has been commonly applied in nursing in the form of short-term groups to enhance self-management behaviors among adolescents and young adults [].

Building on our preliminary study [] and systematic review [], we designed a multicomponent intervention program tailored to enhance self-management behaviors in adolescents and young adults with IBD. This program was delivered through short-term remote group sessions and integrated health education, solution-focused intervention, peer support, and mindfulness training to address the basic psychological needs underlying self-management behaviors, thereby promoting the initiation and maintenance of self-management behaviors.

Objectives

This research primarily aimed to evaluate the effectiveness of this intervention program over standard care in fostering self-management behaviors among adolescents and young adults with IBD. The ancillary goals included assessing its effectiveness in improving the perceived social support and basic psychological needs, diminishing levels of anxiety and depression, and lessening disease activity in this group.

Methods

This study was implemented in accordance with the predefined trial protocol [] and was reported according to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines [].

Study Design and Setting

Conducted between July 2024 and January 2025, this research entailed a double-center, single-blind, 2-arm randomized controlled trial in gastroenterology units of 2 tertiary hospitals (1 pediatric hospital and 1 general hospital) in Chongqing, China. Chongqing stands as a municipality under direct administration and a central national city in China.

Participants

Inclusion criteria were diagnosis of ulcerative colitis or Crohn disease [], age ranging from 13 to 24 years [], and ability to provide informed consent and express oneself clearly. Exclusion criteria were having severe intellectual impairment; pregnancy; history of cancer or active cancer diagnosis; currently receiving psychiatric medications, therapy, or other psychological intervention; and refusal to participate. Withdrawal criteria were voluntary withdrawal for personal reasons, accompanied by an exit interview to elucidate the reasons for withdrawal; and loss of contact.

Informed Consent and Baseline Assessment

A researcher (DLW) recruited participants from inpatients at the gastroenterology wards of the 2 hospitals in July 2024. Eligible patients were identified by reviewing daily admission lists and approached directly in their wards. The researcher provided a verbal explanation of the study and obtained written informed consent from participants or guardians. For participants younger than 18 years, parental consent was required before obtaining the adolescents’ consent. The recruiting researcher was not involved in the delivery of the intervention.

The baseline assessment was administered via a unique web link to the questionnaire hosted on the Wenjuanxing platform (a Chinese online survey tool compliant with data privacy regulations) within 24-48 hours after obtaining informed consent. Following completion of research ethics and survey administration training, the researchers (JJH and XW) conducted a baseline assessment, which included (1) collection of general information, including age, gender, residence, ethnicity, annual household income, current educational background, main caregiver, disease type and duration, and surgical history; and (2) assessment of outcome variables, as described in “Outcome Assessment” section.

Sample Size

The sample size was calculated using PASS software (version 16.0; NCSS Limited Liability Company), with parameters derived from a related previous study []. Specifically, that study [] reported a mean difference of 10.1 in self-management behavior scores between the 2 comparison groups, with a corresponding pooled SD of 5.54. Setting a significance level (α) of .05 (2-tailed) and a desired statistical power of 0.8 (80%), the initial calculated sample size was 47 participants. After accounting for a projected dropout rate of 19% (9/47), the final minimum sample size was determined to be 56 participants, with no fewer than 28 individuals in each group (intervention group and control group).

Randomization and Blinding

Following enrollment, participants were assigned sequential numbers. A researcher independent of the study team then randomly allocated them to the control and intervention groups at a 1:1 ratio, using random numbers generated by the RAND function in Excel software (Microsoft Corp). To ensure allocation concealment, allocation results were stored in sequentially numbered, sealed envelopes maintained by an independent research assistant external to the research team and opened only at the time of intervention initiation. Participants, the recruiter, outcome evaluators, and the data analyst were blinded to group assignments.

Intervention

Control Group

Routine care was provided to the control group, including face-to-face health education during hospitalization and at discharge, a telephone follow-up within 1 week of discharge, and real-time doctor-patient communication via WeChat (a widely used social media app in China). While not formally standardized across all settings, this communication method aligns with local clinical practices in our region for maintaining postdischarge engagement.

Intervention Group

The intervention group received the remote intervention program in addition to routine care. To develop this program, a stakeholder workshop was organized. For this workshop, 2 adolescents and young adults with IBD (aged 17 years with a 3-year disease history and 21 years with a 5-year disease history, respectively) and 13 health providers (see Table S1 in for details) were invited to discuss and revise the draft program, culminating in the finalization of a multicomponent remote group intervention program. In addition, data on the health care providers’ judgment bases and their familiarity were collected (Tables S2 and S3 in ). Based on these judgment bases and familiarity levels, we further calculated the authority coefficient of the health care providers’ judgments. The specific calculation principles and results are provided in the “Health Care Providers’ Judgments” section of .

The intervention program is detailed in Table S4 in . This program consisted of 9 weekly sessions facilitated through a remote conferencing platform (Tencent Meetings software; Tencent Holdings Limited). This 9-week duration aligned with the semester vacation of Chinese students, which was expected to increase their participation enthusiasm. With the exception of the initial and final weeks, which focused on starting and ending the program, every weekly session comprised these components:

1. Health education: This component covered medication, dietary management, physical exercise, disease monitoring, vaccination, and home care procedures. Its objective was to enhance self-management knowledge and satisfy the need for competence.
2. Solution-focused intervention: This involved goal-setting discussions, exception-seeking questions, scaling questions, miracle questions, and relationship-oriented questions, aiming to comprehensively boost the satisfaction of basic psychological needs.
3. Peer support: Participants engaged in discussions and shared their experiences and insights, fulfilling the need for relatedness. Volunteers from local patient organizations were also invited to share their stories, encouraging and motivating participants to open up.
4. Mindfulness training: This component aimed to relax the emotion and enhance the perception of internal and external resources.

Regulating Quality

To guarantee the effectiveness of the program’s execution within the intervention group, these steps were implemented:

Preparation of Intervention Materials

To aid participants in fully grasping the program, a uniform manual, a tailored canvas bag, and a pen (illustrated in Figure S1 in ) were created and disseminated.

Implementation of the Intervention

The nurse (YFZ) received training from the psychological counselor (YYC). The counselor participated throughout the intervention process to provide quality supervision and guidance.

The intervention adopted a group discussion approach. Using the online conferencing Tencent Meetings software, participants were randomly divided into smaller groups of 2-3 members. After the group discussions, a collective sharing session was held to enhance engagement.

Reinforcement of Intervention Effects

Relevant homework assignments were assigned to reinforce and solidify the effects of the intervention.

After each intervention activity, adolescents were required to complete a feedback scale to rate their satisfaction on a scale of 1-5.

For participants unable to attend sessions in real time, the intervention was documented via video recording of the full group session. Researcher YFZ supervised these participants to ensure that they viewed the recorded videos within 1 week of the session.

Outcome Assessment

Information was gathered by researchers (JJH and XW) through the self-reporting questionnaire on the Wenjuanxing platform, with the exception of disease activity, which underwent external evaluation via the electronic medical record system and phone interviews.

Measurement of the Main Outcome Indicator: Self-Management Behavior

We used the Self-Management Behavior Scale of Inflammatory Bowel Disease, developed by Chinese scholars [], to assess the self-management behaviors of the participants. The scale encompasses 7 dimensions: medication management, dietary practices, disease monitoring, emotional regulation, physical exercise, daily life, and resource utilization, and it comprises 36 items. Responses are gauged on a 5-point scale, ranging from 1 (never) to 5 (always). The Cronbach a coefficient of the scale was 0.945 in the original study and 0.941 in this study. Chinese scholars commonly use this scale to evaluate self-management in patients with IBD [].

Measurement of Secondary Outcome Indicators

Basic Psychological Needs

This study used the Chinese version of the Basic Psychological Needs Satisfaction Scale [], adapted from the original one []. This version contains 9 items and 3 dimensions, namely, autonomy, competence, and relatedness. The rating for each item ranges from 1 (strongly disagree) to 7 (strongly agree). The Cronbach a coefficient of this scale was 0.86 in the original study and 0.941 in this study. This version of this scale has been widely used [].

Perceived Social Support

This study used the Chinese version of the Perceived Social Support Scale [], adapted from the original one []. The scale consists of 12 items divided into 3 dimensions: family support, friend support, and other support, and is assessed on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The Cronbach a coefficient of the scale was 0.88 in the original study and 0.943 in this study. This scale has been widely used [].

Anxiety

The Generalized Anxiety Disorder 7-item Scale (GAD-7) was used to assess the severity of anxiety over the past 2 weeks. Comprising 7 elements, this item is evaluated on a scale ranging from 0 (not at all) to 3 (almost daily). The total score of GAD-7 ranges from 0 to 21, with score ranges interpreted as follows: 0-4 points indicate no significant anxiety symptoms, 5-9 points denote mild anxiety symptoms, and a score of ≥10 points indicates the generalized anxiety symptoms []. The Chinese version of the GAD-7 has been widely used in clinical practice []. The Cronbach a coefficient of this scale was 0.937 in this study.

Depression

The Patient Health Questionnaire-9 (PHQ-9) was used to assess the level of depression in the past 2 weeks. It contains 9 items, which are scored on a scale from 0 (not at all) to 3 (almost every day). The total score of the PHQ-9 ranges from 0 to 27, with established interpretive criteria: 0-4 points indicate no significant depressive symptoms, 5-9 points denote mild depressive symptoms, and a score of ≥10 points is indicative of moderate to severe depression symptoms []. The Chinese version of the PHQ-9 is a reliable measure of depressive symptoms in clinical practice []. The Cronbach a coefficient of this scale was 0.920 in this study.

Disease Activity Level

For participants with Crohn disease, the Pediatric Crohn’s Disease Activity Index was applied to those younger than 18 years, while the Crohn’s Disease Activity Index was used for those aged 18 years and older. For participants with ulcerative colitis, the Pediatric Ulcerative Colitis Activity Index was used for those younger than 18 years, and the Simple Clinical Colitis Activity Index was used for those aged 18 years and older. Using these measurements, the severity of disease activity was categorized into remission, mild, moderate, or severe [].

Evaluation Schedule

Outcome indicators of participants were assessed at baseline (T0), immediately after the intervention (T1), and 12 weeks after the intervention (T2). For validity, an interim analysis was conducted at T1: no significant differences in primary or secondary outcomes would have resulted in a decision to stop T2 follow-up; if differences existed, results remained confidential until all data collection was complete (in line with the blinded protocol), with details available in the study protocol [].

Statistical Analysis

Statistical analyses were conducted using SPSS software (version 26.0; IBM Corp). To examine categorical data across 2 groups, either the chi-square test or the Fisher exact test was used, with findings displayed in terms of frequencies and percentages. Normality tests were performed on continuous variables to determine the suitable statistical techniques. Information showing a normal distribution underwent analysis via the t test and was presented as mean (SD). In contrast, data that did not follow a normal distribution were evaluated using the rank sum test and presented as median (IQR).

For normally distributed data assessed at multiple time points within a group, mixed-design analysis of variance was used. Effect sizes were presented as partial eta-squared (η² ). The value of η² ranges from 0 to 1 and can be interpreted as small (η² ≥0.01), medium (η²≥0.06), and large effects (η²≥0.14) []; for non–normally distributed data, the Friedman test was applied, with Bonferroni correction used for post hoc multiple comparisons. The significance level (α) was set at .05. For Bonferroni correction, the adjusted significance threshold was calculated as 0.05 divided by the number of comparisons (n=3), resulting in a corrected statistical significance level of P<.017. Subgroup analyses were not conducted due to the small sample size in this study.

A Little’s Missing Completely At Random test was performed to evaluate the missing mechanism (χ²₁₄=10.82; P=.63), confirming that the data were missing completely at random. Missing data were addressed through multiple imputation methods. The analysis of this study adhered to the principles of intention-to-treat analysis.

Ethical Considerations

Approval for the research was granted by the ethics review boards of the Children’s Hospital of Chongqing Medical University and Chongqing General Hospital (approval numbers: file nos. 2023,395 and KYS2024-008-01). No ethical exemption was applied. Written informed consent was obtained from all participants (with guardians providing consent for those younger than 18 years), and the informed consent forms are available in . No secondary analysis was planned, with ethics approval for no extra consent. Data were deidentified (unique codes) and stored encrypted. No participant compensation was provided. No identifiable images were included; future use requires consent and form uploads.

Result

Overview

Initially, 91 potential participants were identified, with 17 excluded: 2 ineligible for failing to meet the inclusion age, 3 ineligible due to unconfirmed diagnosis, and 12 declining participation for personal reasons. As a result, 74 participants were recruited, with 37 assigned to the intervention group and 37 to the control group. Of the participants, 74 (100%) completed the evaluation at T0; 72 (97.3%) completed the evaluation at T1, with 2 cases of missing data (2.7% missing rate); and 69 (93.2%) completed the evaluation at T2, resulting in 5 cases of missing data (6.8% missing rate). A flow diagram of the study is shown in . No important harms or unintended effects were observed in either group.

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In the intervention group, the mean real-time participation rate during the 9 online intervention sessions was 79.52% (95% CI 66.8%-92.2%), while the recorded video-viewing rate was 20.48% (95% CI 8.1%-32.9%). The satisfaction score was mean 4.97 (SD 0.08, 95% CI 4.94-5.00) on a 5-point scale.

Baseline Characteristics

The age of the participants was mean 18.95 (SD 2.96) years. Males constituted 71.62% (53/74) of the sample. displays the sociodemographic details and clinical traits of the participants, revealing no significant difference between the intervention and control groups at baseline.

Effects of the Intervention on the Primary Outcome

As shown in , regarding self-management behaviors, a significant time × group interaction was observed (F_{interaction effect}=8.339; P<.001); between-group comparisons showed no difference at T0 (95% CI –12.728 to 5.539; P=.435, η²=0.008) but significant superiority of the intervention group at T1 (95% CI –24.370 to –8.982; P<.001, η²=0.206) and T2 (95% CI –22.594 to –5.784; P=.001, η²=0.136); and within-group analyses revealed no changes in the control group (P=.16, η²=0.050) but significant differences in the intervention group (P<.001, η²=0.426). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in A. For the analysis of the scores across various dimensions of self-management behaviors, refer to Table S6 in .

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Effects of the Intervention on Secondary Outcomes

Effects of the Intervention on Perceived Social Support

As shown in , regarding perceived social support, a significant time × group interaction was observed (F_{interaction effect}=3.264; P=.04); between-group comparisons showed no difference at T0 (95% Cl –9.030 to 0.868; P=.105, η²=0.036) but significant superiority of the intervention group at T1 (95% CI –13.932 to –4.068; P=.001, η²=0.155) and T2 (95% CI –11.890 to –1.407; P=.014, η²=0.082); and within-group analyses revealed no changes in the control group (P=.76, η²=0.008) but significant differences in the intervention group (P=.001, η²=0.190). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in B. For the analysis of the scores across various dimensions of perceived social support, refer to Table S7 in .

Effects of the Intervention on Basic Psychological Needs

As shown in , regarding basic psychological needs, no significant time × group interaction was observed (F_{interaction effect}=1.231; P=.30); between-group comparisons showed no difference at T0 (95% CI –6.173 to 0.930; P=.146, η²=0.029) but significant superiority of the intervention group at T1 (95% CI –8.323 to –1.569; P=.005, η²=0.106) and T2 (95% CI –7.720 to –0.172; P=.04, η²=0.057); and within-group analyses revealed no changes in the control group (P=.98, η²=0.001) but significant differences in the intervention group (P=.049, η²=0.081). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in C. For the analysis of the scores across various dimensions of basic psychological needs, refer to Table S8 in .

Effects of the Intervention on Anxiety

The Mann-Whitney U test was conducted to compare anxiety scores between the 2 groups at different time points, with the results summarized in . At T0, there was no significant difference detected among the groups (P=.75, z=–0.321). At T1 and T2, the intervention group demonstrated statistically lower scores than the control group (P=.04, z=–2.096; P=.007, z=–2.69). Within-group comparisons revealed that the control group’s anxiety scores exhibited a statistically significant overall difference (P=.007, χ²₂=9.894), with post hoc analysis indicating that the score at T2 was significantly lower than that at T0 (P<.017). For the intervention group, anxiety scores also showed a statistically significant overall difference (P<.001, χ²₂=32.463), with post hoc analysis demonstrating that scores at both T1 and T2 were significantly lower than that at T0 (P<.017). The trend of these results is illustrated in D.

Effects of the Intervention on Depression

The analysis of depression scores is shown in . At T0, the 2 groups showed no significant difference (P=.92, z=–0.098). At T1 and T2, the intervention group demonstrated statistically lower scores than the control group (P=.048, z=–1.981; P=.03, z=–2.115). Within-group comparisons revealed that the control group’s depression scores exhibited a statistically significant overall difference (P=.03, χ²₂=6.764). However, the post hoc analysis showed no statistically significant differences between time points in the control group (P>.017). For the intervention group, depression scores also showed a statistically significant overall difference (P<.001, χ²₂=15.228), with post hoc analysis demonstrating that scores assessed at T1 and T2 were markedly less than that at T0 (P<.017). The trend of these results is illustrated in E.

Effects of the Intervention on Disease Activity

Disease activity between the 2 groups was evaluated using the Mann-Whitney U test, as detailed in . Findings showed negligible variance in disease activity between the groups at T0 and T1 (P=.44, z=–0.769; P=.16, z=–1.403). At T2, a higher percentage of participants in the intervention group experienced remission than those in the control group, showing statistically significant differences (P=.03, z=–2.231).

Discussion

Principal Findings

Self-determination theory has been widely validated for improving self-management behaviors in other populations with chronic diseases [,]. A key innovation of this study was its first application of this theory to adolescents and young adults with IBD, offering a novel theoretical framework for clinical interventions targeting this population. Based on the mechanisms underlying the formation and sustainability of self-management behaviors [], this study developed a remote multicomponent program, integrating health education, solution-focused intervention, peer support, and mindfulness training This intervention program showed significant effects in enhancing self-management behaviors, strengthening perceived social support, and fulfilling basic psychological needs among adolescents and young adults with IBD, while also mitigating their anxiety, depression, and disease activity. Notably, unlike traditional in-person intervention, this remote program could offer greater flexibility. The favorable real-time participation rate and satisfactory feedback score in the intervention group indicated that the program was well received by participants.

Regarding self-management behaviors, the intervention group demonstrated superiority over routine care, highlighting that the intervention program should serve as a valuable and beneficial complement to routine care. Routine care primarily relies on one-way health education. As a complex, multidimensional construct (encompassing disease, emotional, and role management), self-management behaviors cannot be fully improved by routine care’s typical one-way health education []. Critically, most self-management intervention studies have been led by specialized psychotherapists [], rendering them unsuitable for nurse-led clinical settings. Although this study used a multidisciplinary and multicomponent intervention, its overall nurse-led approach could enhance clinical feasibility and offer insights for regions with similar clinical contexts.

In perceived social support, the intervention group exhibited a significant advantage over the control group. This advantage in the intervention group could be plausibly attributed to the intervention’s multicomponent design. Unlike extant literature [] that predominantly used peer support to modulate psychological outcomes in patients with IBD, this study innovatively integrated peer support with solution-focused intervention, transcending passive reciprocal assistance to proactively cultivate participants’ capacity to identify, mobilize, and optimize inherent support resources within their lived contexts.

In addition, this study revealed that the scores of competence and relatedness (2 dimensions of basic psychological needs) in the intervention group were higher than those in the control group at T1 and T2 (see Table S8 in ). However, the autonomy dimension did not achieve significance either within groups or between groups at all time points, as elaborated in Table S8 in . Although theoretical literature [] posited that solution-focused intervention could enhance the satisfaction of basic psychological needs, its practical application should be contextualized within specific cultural backgrounds. Within an Asian cultural context, parental authority and overprotection often hinder the development of adolescents’ autonomy []. Against this cultural backdrop, the autonomy of participants in this study proved challenging to foster in the absence of parental involvement. From the perspective of self-determination theory, this study framed autonomy around attaining self-independence. Notably, the program might not account for adolescents’ potential to view “relying on parents” as an autonomous choice. Future research should thus reframe objectives to explore how adolescents use parental support to meet autonomy needs, rather than solely emphasizing self-independence.

Although the intervention program outperformed routine care in reducing anxiety and depression in the participants, within-group analyses showed that the control group also had significantly lower anxiety scores at T2 than at T0. This finding implied that routine care had a certain positive impact on emotion. Alternatively, it could be inferred that the potential for self-growth among adolescents and young adults with IBD was consistent with other research [] that reported posttraumatic growth trends in this population. This observation corroborated the use of a solution-focused approach, which guided participants to recognize intrinsic resources (inherently present in participants, with the intervention facilitating awareness of personal strengths). Furthermore, this study advanced posttraumatic growth theory from phenomenological description to intervention-based empirical validation in this population, providing an entry point for investigating the mediating mechanisms of the disease-related stress and self-growth pathway.

Finally, there were no significant changes in disease activity levels at T1; however, a significant improvement was observed at T2, providing empirical support for the influence of mental health on disease activity, consistent with “gut-brain axis” theory []. This result suggested that the psychological intervention did not yield immediate disease benefits and sustained engagement was needed to modulate brain-gut cross talk, clinically guiding health care providers and patients to set realistic expectations for long-term adherence. Notably, while other study [] has also reported that adding psychological interventions to routine care effectively alleviates disease activity, these interventions were predominantly led by specialized psychologists. In contrast, the nurse-led model of this study could render gut-brain axis-informed care accessible in regions with limited access to psychologists.

Limitations

However, this study still has some limitations. The long-term effectiveness of this study remains to be further verified, as follow-up was limited to 12 weeks. It is recommended to conduct long-term follow-up to determine whether the intervention effect is sustainable in the long run. Furthermore, the sample in this study mainly consisted of individuals with Crohn disease (65/74, 87.84%), males (53/74, 71.62%), and urban populations (62/74, 83.78%). Although this is in line with the epidemiological characteristics of IBD in China [], the imbalance limits generalizability. Efficacy in subgroups such as rural residents or patients with ulcerative colitis remains untested, as these groups may face unique barriers (eg, limited access to remote resources in rural areas) affecting outcomes. In addition, while the sample size calculation confirmed sufficient statistical power for the primary outcomes, the modest sample size may hinder detection of small but clinically meaningful effects (eg, the autonomy dimension of basic psychological needs).

Conclusions

Based on the self-determination theory, this study developed a short-term, group-based, remote, and multicomponent intervention program, integrating health education, peer support, solution-focused intervention, and mindfulness training. The program demonstrated improvements in self-management behaviors, perceived social support, and basic psychological needs among adolescents and young adults with IBD, while also alleviating their anxiety, depression, and disease activity. Theoretically, this study validated the application of a combination of multiple intervention components under the guidance of self-determination theory in adolescents and young adults with IBD. Practically, it was shown that the nurse-led remote intervention was feasible and accessible. Future research should verify the program’s long-term effectiveness and expand to more balanced samples to enhance generalizability; optimizing the intervention to address unmet autonomy needs could further boost its clinical use.

Introduction

Chronic urinary conditions, such as benign prostatic hyperplasia (BPH), necessitate ongoing patient self-management, akin to other chronic diseases such as hypertension, diabetes, and asthma. Despite this need, there is a notable lack of tools enabling patients to monitor and manage urinary symptoms autonomously at home. This absence increases the risk of symptom progression and the onset of secondary urinary disorders. Even in cases where pharmacological treatments are suboptimal, patients lack effective methods for self-monitoring [].

Postoperative urinary complications can also occur following interventions for prostate enlargement. The inability of patients to self-assess their condition may result in delayed recognition of issues, potentially necessitating urgent interventions, such as urethral catheterization []. Traditional methods, such as the use of a urination diary, which requires patients to record their symptoms for several days using paper and a measuring cup, are cumbersome and often impractical. If these records are misplaced, patients lose the ability to accurately track their urinary habits, and health care professionals face additional burdens in manually calculating metrics such as daily and nocturnal urine output.

The integration of digital therapeutics presents significant benefits, including the absence of toxicity and adverse side effects, minimal costs, and continuous real-time management []. These tools facilitate 24-hour monitoring of patient status and allow for personalized patient analytics by empowering patients to actively participate in data collection and management. Individuals can actively engage in self-health monitoring and retrieve evaluation results before consulting medical personnel, reducing time consumed during in-person visits to clinics and overcoming geographic barriers when physical presence is limited due to infection or regional availability of medical services.

As an attempt to address the needs of both clinicians and patients for a personalized device to measure and monitor voiding-related outcomes during and after treatment, an acoustic uroflowmetry was incorporated into a mobile app [,]. Uroflowmetry, which is a pivotal test for the evaluation of lower urinary tract function and voiding patterns during diagnosis and treatment, requires the patient to visit the hospital and undergo testing in a controlled setting. Moreover, single measurements obtained in a hospital setting may not reflect a patient’s usual voiding patterns. Acoustic uroflowmetry using mobile apps provides a practical alternative to replace conventional methods, allowing repeated measurements in familiar home environments, enabling remote monitoring as well as accessibility for patients, and improving efficiency in clinical practice.

However, despite worldwide interest and the development of similar tools, no study has generated data on the comparative outcome between mobile uroflowmetry and in-office measurements for surveillance of posttreatment change. This study compares an acoustic analysis–based uroflowmetry, which calculates urine volume by recording sounds with a smartphone, with a conventional physical urinary flow test machine in patients undergoing surgery for BPH. The aim is to evaluate whether traditional in-office tests can be effectively replaced.

Methods

Ethical Considerations

This study received approval from the institutional review board of Seoul National University Bundang Hospital (B-2207-769-305). All data analyzed in this research were anonymized, and informed consent was obtained from all patients participating. The participants received monetary compensation of South Korean ₩ 100,000 (approximately US $67.90) for hospital visitation and traveling fees during the entire study. To ensure privacy, personal identifiers were fully removed, and the analysis was conducted anonymously. All procedures adhered to the relevant ethical guidelines and regulations. A STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist was submitted as supplementary material ().

Study Design and Population

Patients diagnosed with BPH planning to undergo surgery (transurethral resection of prostate [TURP]) at 3 tertiary institutions (Seoul National University Bundang Hospital, Ewha Womans University Medical Center, and Kyung Hee University Medical Center), who were older than 20 years, were screened for eligibility and enrolled after obtaining informed consent. This study was designed as a prospective pilot observational study in a single cohort without a control to validate the efficacy of mobile uroflowmetry measurements compared to conventional methods conducted in an office. On the basis of previous literature [,] suggesting a moderate correlation (expected r=0.6), a minimum of 20 patients would provide 80% power to detect a statistically significant correlation at a 2-sided α level of .05. To improve the precision of the correlation estimate, allow for potential measurement failure or incomplete data, and support the feasibility of future definitive studies, we increased the target enrollment to 40 patients. During the first outpatient visits, patients planning to undergo surgery for BPH were recommended for screening and enrollment, if eligible. After initial study enrollment, individual mobile devices with the app installed were distributed for preoperative evaluation of voiding patterns and parameter measurements for at least 72 to 96 hours before surgery. In-office measurements were also conducted for comparison. Additional app measurements were taken for the same 4-day periods after 2, 6, and 12 weeks of surgery and compared to conventional uroflowmetry measurements conducted at the same intervals of outpatient clinic visits. International Prostate Symptom Scores (IPSS) and uroflowmetry parameters, including maximum flow rate (Q_max) and voided volume (VV), were collected at each visit. At the time of study termination at 12 weeks, all patients completed a written survey using a 0-to-10-point scale for satisfaction. All enrolled participants completed the study protocol, and there were no missing data for any of the outcome variables over the 12-week follow-up period.

In-Office and Mobile App–Based Uroflowmetry

All patients uniformly underwent an in-office conventional uroflowmetry (CubeFlow_S; MCube Technology) at each visit before and after treatment according to the study schedule. Additional app-based uroflowmetry measurements were obtained using the sound-based mobile app proudP (Soundable Health, Inc), a Food and Drug Administration–listed class 2 uroflow meter that has been validated for flow prediction and VV measurements in previous studies [,]. The acoustic flow measurement system uses a wireless, smartphone-based approach with recording capabilities to analyze urinary flow. Acoustic data were captured in real time using a smartphone app. From the recorded sounds, parameters such as urinary volume, flow-related metrics (eg, peak urinary flow and average urinary flow), urinary flow patterns (eg, continuous or intermittent), and time-related parameters (eg, maximum voiding time and voiding duration) were calculated. Acoustic characteristics were assessed using audio processing, signal preprocessing, and spectral analysis techniques. A predictive model was then used to estimate urinary flow and associated parameters. Postprocessing produced data regarding accuracy and voiding metrics.

To minimize variability due to height or ambient surrounding noise, patients were instructed to ensure the restroom environment was as quiet as possible and place their smartphone approximately 80 cm away from the toilet before using the mobile app. They were then guided to launch the mobile uroflowmetry. While standing in front of the toilet, patients urinated, aiming for the center of the bowl, when possible, to optimize measurement accuracy. Before the actual experiment, all participants received standardized instructions on how to perform uroflowmetry using the in-hospital system to ensure consistent and reliable data collection.

The recorded sounds were analyzed using audio editing software (Audacity, version 2.2.2; Audacity Open Source Team and GoldWave). Signal preprocessing and postprocessing as well as the development of flow prediction models were conducted using MATLAB (version R2017b, 9.3.0; MathWorks, Inc) and Python (Python Software Foundation). To enhance accuracy, the acoustic analysis algorithm included preprocessing and postprocessing refinements to eliminate short-term artifacts and outliers, correct background noise levels, and remove specific noise bands. Validation of uroflowmetry parameters, including Q_max and VV, was performed in separate studies [].

Survey Method

To assess patient satisfaction with the mobile uroflowmetry system, we developed a brief, study-specific questionnaire tailored for use in this pilot validation study, and a single-session self-administered survey was conducted at the final in-office visit. The questionnaire was created collaboratively by the study investigators, including urologists and research coordinators, based on their clinical experience and anticipated domains of usability (eg, convenience, clarity of instructions, and perceived reliability of the mobile app). Patients were asked whether the use of the app-based monitoring (1) allowed better self-understanding of their clinical status, (2) improved the clinician’s understanding of their status, (3) was easy to use, and (4) was overall satisfactory. All scores were provided as a numerical value on a point scale ranging from 0 to 10.

Statistical Analysis

Independent 2-tailed t tests and equal-variance tests were used to assess whether there were statistically significant differences between conventional measurements obtained via in-office uroflowmetry–based and acoustic uroflowmetry–based mobile data collection. These tests were selected to validate the statistical characteristics of uroflowmetry measurements, including Q_max as the primary comparative factor, with VV and IPSS change as secondary measures. The analysis and calculations were conducted using Python (version 3.6.9; Python Software Foundation), along with the SciPy (version 1.5.14; Python Software Foundation) scientific computing package and R (version 4.3.1; R Foundation for Statistical Computing). Categorical variables were analyzed with chi-square and Fisher exact tests, and ANOVA was used for additional continuous variables. Normality was assessed using the Shapiro-Wilk test, and homogeneity of variance was evaluated with the Levene test. In cases where assumptions were not met, appropriate nonparametric alternatives (eg, Mann-Whitney U test and Kruskal-Wallis test) were used. Further assessment of the agreement of the 2 different uroflowmetry parameters was performed with Bland-Altman analysis, with the mean difference and 95% limits of agreement (defined as mean difference of +1.96 and –1.96 × SD of the paired differences) calculated according to standard procedures. To interpret clinical relevance, we adopted a provisional threshold of +10 mL/s and –10 mL/s for Q_max, as variations of this magnitude are generally regarded as unlikely to change the clinical interpretation of flow pattern or degree of obstruction in typical urodynamic practice [].

Results

A total of 46 treatment-naive patients with symptomatic BPH undergoing endoscopic surgery were screened, and 41 (89%) patients were finally enrolled, with 5 (11%) declining participation. The mean age of all patients was 67.4 (SD 5.5; range 58-79) years. Assessment of the accuracy and representability of acoustic uroflowmetry as compared to in-office measurements for Q_max resulted in a Pearson correlation of 0.743 (P<.001; ). The mean of the difference observed in the Bland-Altman analysis was 1.57 (SD 7.0), with upper and lower limits of agreement of 15.4 and –12.2, respectively.

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Improvement in IPSS over the 12-week period was significant for all patients who underwent TURP for all specific parameters, including total IPSS and quality of life, as well as for both obstructive and irritative symptoms (; Figure S1 in ). Mean improvement of 10.2 and 8 points was observed for total IPSS and obstructive IPSS, respectively (both P<.001).

Specific uroflowmetry parameters, as measured from the mobile device, well reflected improvements in symptom scores, with baseline mean Q_max of 12.8 (SD 4.1) improving to 20.3 (SD 5.4) at the end of the study, similar to results measured from in-office uroflowmetry, which showed a similar range of improvement from a mean of 13.0 (SD 6.3) to 23.2 (SD 9.8) in the same period (). No significant differences in VV were observed.

Changes in IPSS to Q_max as measured by the app were significant overall, with modest correlation () and the highest Pearson correlation of –0.490 for obstructive IPSS, followed by –0.478 for total IPSS (Figure S2 in ). Individual questions for intermittency and weak stream showed the highest correlation as measured by acoustic uroflowmetry (r=–0.490 and r=–0.580, respectively).

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When stratified by prostate volume, patients with larger prostates (≥80 mL) demonstrated greater improvement in Q_max at 12 weeks compared to those with smaller prostates (<80 mL). Mean Q_max in the 80 mL or greater prostate volume group increased from 13.1 (SD 4.8) mL/s at baseline to 22.8 (SD 4.4) mL/s at 12 weeks using the app-based method compared with a 10.1 mL/s increase measured by in-office uroflowmetry. In contrast, patients with prostate volumes less than 80 mL showed a smaller mean increase (app: mean 13.0, SD 4.0 to mean 19.4, SD 5.3 mL/s; in office: mean 12.6, SD 5.3 to mean 22.8, SD 11.9 mL/s). Correlation between the 2 methods was also slightly higher in the larger prostate subgroup (r=0.692) than in the smaller prostate group (r=0.642; both P<.001), suggesting more consistent agreement in men with enlarged glands (Table S1 in ).

Further stratification by severity of IPSS showed both improvements reflected in patients with either moderate or severe IPSS, with a high Pearson correlation value of 0.751 and 0.734 in each group (all P<.001; Figure S3 in ).

Survey results for patient satisfaction are shown in . All patients were highly satisfied with the measurement process and felt the app was easy to use. Subjective assessment of the additive value of the app was remarkably high. No difference in the use of the app by men aged 70 years and older was observed.

A sample representation of post-TURP changes and measurements conducted with the mobile uroflowmetry is presented in , where a patient’s preoperative obstructive patterns and postoperative improvement of uroflowmetry plateau are well displayed, with an initial Q_max of 10.2 and VV of 297 improved to 20.0 and 324, respectively, at 12 weeks after surgery.

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Discussion

Principal Findings

This is the first prospective clinical trial to evaluate the effectiveness and feasibility of an acoustic app-based uroflowmetry to monitor patients after clinical intervention. The mobile measurements conducted at home were clinically reliable, with a strong correlation to IPSS improvement after surgery, also reliably reflecting the absolute improvement in Q_max with TURP, especially for patients with obstructive IPSS. Q_max, as measured with the app, showed consistent change regardless of prostate size as well as when stratified by severity of IPSS, suggesting that the technology can be reliably used in a wide spectrum of male patients with lower urinary tract symptoms. Older patients were equally satisfied with the process and felt at ease using the app, suggesting that as long as the patient is familiar with a mobile device, uroflowmetry measurements for clinical observation can be effectively conducted without technical difficulty.

Lee et al [] performed a prospective comparative analysis in 16 male pediatric patients using the same app to validate the technology’s strong correlation to standard measurements. A smartwatch-based uroflowmetry model was constructed by a Spanish team after extracting acoustic features from voiding stream sounds, similar to the method described in this study, and it displayed good correlation []. El Helou et al [] used a similar approach in 44 healthy young men, and by mapping total sound energy with VV, the model was successfully able to estimate flow rate with a mean absolute error of 2.41 mL/s. Dawidek et al [] compared a conventional uroflowmetry with an audio-based uroflowmetry (TeleSonoUroFlow) app, achieving a poor correlation for Q_max (r=0.12) and failing to show consistent results despite modest improvement in healthy individuals. However, these studies, by design, performed only comparisons of the mobile uroflowmetry versus conventional clinic-based measurements and did not evaluate whether the technology could accurately represent the changes that occur during and after treatment. Overall, a recent meta-analysis by Rangganata et al [] showed the efficacy of mobile acoustic uroflowmetry in male participants to be strong, with positive correlation for VV and Q_max, as shown in our study, as well as for other uroflowmetry parameters, including voiding time and average flow. Bladt et al [] also showed that at-home measurements can be as useful or even more representative of voiding patterns than hospital measurements, as shown in our sample patient (), in whom multiple app-based measurements were more informative and reliable in tracking voiding pattern changes.

The importance of uroflowmetry and changes in its parameters are paramount in assessing the success and efficacy of surgical treatment in BPH [-]. While preoperative Q_max values typically range from 6.18 to 8 mL/s, Q_max improves significantly after surgery, with studies reporting improvement up to 26.43 mL/s [,]. The average flow rate shows similar changes, with preoperative values from approximately 4.44 to 13.48 mL/s after TURP []. The patients in our cohort showed similar improvement, with most change found in large BPH. The significance of our study lies in the fact that mobile uroflowmetry was sufficient to measure the changes in such parameters after surgical intervention and reflect the measurements performed at outpatient visits, validating the efficacy for use in actual clinical practice. Unlike previous studies that primarily validated acoustic uroflowmetry in healthy volunteers or patients with stable lower urinary tract symptoms, this study evaluated its performance in a postoperative population undergoing active recovery after prostate surgery. In this context, uroflow parameters fluctuate considerably due to progressive relief of obstruction, healing of the bladder neck, and adaptation of detrusor contractility. Demonstrating consistent agreement between acoustic and conventional measurements across this dynamic postoperative trajectory supports the robustness of acoustic uroflowmetry beyond static or screening scenarios. Therefore, our findings extend the clinical applicability of this technology to longitudinal monitoring in the perioperative setting, where repeated, home-based assessments can provide meaningful insights into functional recovery. However, while tracking changes was significantly well correlated, our results suggest caution when considering complete replacement of conventional measurements, as the limits of agreement in this study (–12.2 to 15.4 mL/s) slightly exceed the prespecified reference range of +10 mL/s and –10 mL/s, suggesting that although the 2 devices show close overall agreement, individual measurements may differ modestly in real-world clinical use. This difference may reflect consistent measurement conditions at home despite pretraining and guidance during the trial or may result from intraindividual variability in uroflowmetry, which by itself is known to reach approximately 10 mL/s []. This finding highlights the need and necessity for multiple measurements in a single individual during clinical evaluation and monitoring, underscoring the importance and potential for remote mobile measurements.

Another interesting point to mention was that a stronger agreement was observed in men with larger prostates or higher baseline IPSS. This may reflect the more stable and reproducible flow characteristics typically seen in obstructive voiding patterns, in which urinary flow is typically slower and of longer duration, producing clearer and less noisy acoustic signals that enhance the reliability of the app’s waveform detection. Conversely, individuals with smaller prostates or milder symptoms often exhibit higher peak variability and shorter flow times, which can amplify measurement discrepancies between acoustic and conventional methods. These subgroup findings suggest that app-based uroflowmetry may be particularly accurate for monitoring patients with clinically significant bladder outlet obstruction, while careful interpretation is still warranted in those with near-normal flow profiles.

Beyond demonstrating technical validity, this study also highlights the digital health potential of acoustic uroflowmetry. The app-based measurement system allows patients to record voiding data conveniently without additional equipment, such as measuring cups or paper logs. Previous studies have reported higher satisfaction and adherence with app-based systems compared to conventional uroflowmetry, even among older adults unfamiliar with smartphones []. In our cohort, similar usability was observed among participants aged more than 70 years, likely reflecting both the intuitive interface design and the brief in-office education that enhanced confidence and accuracy of use [,]. The automatic generation of an electronic voiding diary may have further increased engagement by reducing manual documentation and simplifying self-tracking.

From a clinical workflow perspective, such usability supports integration of acoustic uroflowmetry into telemedicine and self-management pathways for BPH and postoperative monitoring. Home-based acoustic measurements can be securely transmitted to clinicians for asynchronous review, enabling continuous monitoring of recovery trends and early identification of voiding deterioration without frequent in-person visits. When combined with patient-reported outcomes, such as IPSS, app-based flow metrics may enhance remote clinical decision-making and support personalized treatment adjustments. Integration with electronic medical records and automated alerts based on individualized thresholds could further streamline care within digital urology ecosystems.

Nevertheless, several equity and accessibility considerations should be acknowledged. Smartphone literacy remains a potential barrier, particularly among older or socioeconomically disadvantaged populations. In our study, targeted education and a simplified user interface mitigated many of these challenges, but broader implementation will require interfaces accommodating sensory or cognitive limitations. Cost and device availability also remain relevant, as not all patients may have access to compatible smartphones or stable internet connections, potentially widening digital health disparities. Data privacy and cybersecurity represent additional priorities. Because acoustic recordings and voiding profiles constitute personal health information, strict adherence to encryption, anonymization, and data protection regulations (eg, General Data Protection Regulation and Health Insurance Portability and Accountability Act) is essential. Finally, regulatory approval processes for software as a medical device must be clearly defined to ensure safety, performance, and clinical accountability. Early engagement with regulatory authorities and compliance with international validation frameworks will be crucial for widespread clinical adoption.

Collectively, these findings suggest that app-based uroflowmetry not only provides accurate and reproducible measurements but also aligns with the evolving paradigm of patient-centered, connected urological care. With careful attention to usability, privacy, and equity, such technologies could substantially enhance accessibility to postoperative monitoring and chronic symptom management through scalable digital health integration.

Limitations

This study is not without limitations. First, conventional uroflowmetry was performed at a single session, with repeat measurements conducted only if the patient was unable to void at the first trial or had low VV (≤150 mL), to ensure reliability of the uroflowmetry measurements. However, a single in-office voiding trial may overestimate or underestimate the actual symptoms and change over clinical course, and repeated measurements, as in the mobile uroflowmetry, may be required. Second, no information on TURP clinical variables, such as baseline prostate-specific antigen, resection volume, or pathology, was included in our analysis. While the loss of such information was detrimental to our results, resection percentage as a surrogate for completeness of adenoma resection may have shown a strong correlation with IPSS and Q_max change as estimated from both app-based and in-office measurements, supporting our findings. Moreover, as this study aimed to validate agreement between mobile and in-office uroflowmetry, any such factors would likely have affected both modalities equally and thus are unlikely to alter the comparative findings. Given the exploratory nature of this study, survey questionnaires were custom made and were not validated in a separate study, which may undermine the reliability of the reported outcomes. Limitations associated with the lack of psychometric validation are acknowledged, and future studies should incorporate standardized and validated patient-reported outcome measures to strengthen the assessment of usability. Finally, this study did not include a randomized control group and was conducted in a pilot prospective observational trial setting, limiting the strength of causal inference. However, this design was deliberately chosen to evaluate the feasibility and assess the preliminary performance of the mobile uroflowmetry in a clinical treatment scenario, with the plan of performing larger studies in a randomized and controlled framework to establish the potential replacement of conventional methods. The limited sample size and observational design of this study suggest potential for mobile uroflowmetry; however, they are insufficient to fully support complete replacement of conventional uroflowmetry. Future head-to-head randomized controlled trials comparing long-term outcomes between mobile uroflowmetry and in-office measurements are required to further validate the clinical efficacy of mobile methods. In particular, appropriate methods, such as Bonferroni or false discovery rate correction to address multiple testing and repeated measures, will be required.

Taken together, this study demonstrates the feasibility of using mobile, app-based uroflowmetry as a reliable alternative to conventional in-office measurements. By overcoming the spatial and temporal limitations inherent to traditional uroflowmetry, app-based measurements enable continuous, home-based assessment of postoperative urinary flow dynamics. Unlike previous validation studies limited to healthy or stable populations, our findings extend the applicability of this technology to a postsurgical cohort, showing its potential to capture dynamic recovery patterns and detect functional improvement without requiring frequent outpatient visits. Although no cases of acute retention or early stricture occurred during follow-up, the ability to remotely monitor flow changes suggests a role for early detection of postoperative complications and personalized recovery tracking.

Nonetheless, these findings should be interpreted within the scope of a feasibility study. This work establishes proof of concept and short-term clinical reliability but does not yet address long-term adherence, scalability, or outcome-driven end points. The logical next steps include conducting a randomized controlled trial comparing acoustic and conventional uroflowmetry in diverse clinical settings, followed by broader real-world implementation studies to evaluate cost-effectiveness, user engagement, and system integration within telehealth and electronic medical record platforms. With such validation, app-based uroflowmetry could evolve into a scalable, patient-centered component of precision urological care.

Conclusions

In this prospective pilot observational study, app-based uroflowmetry (proudP) measurements showed reasonable concordance with conventional in-office testing, indicating its feasibility as a tool for perioperative surveillance in BPH surgery. The app-based system effectively reflected both in-office flow values and longitudinal changes in symptom severity, as measured by IPSS, suggesting potential for reliable home-based monitoring of postoperative recovery. Nonetheless, the absence of randomization, the use of a single cohort, and the limited follow-up necessitate caution in interpreting these findings. Future large-scale randomized and real-world implementation studies across diverse populations with lower urinary tract symptoms are warranted to establish the clinical validity, cost-effectiveness, and scalability of app-based uroflowmetry as a practical extension of telemedicine in contemporary urological care.