To validate the effectiveness of the application of a transition programme for adolescents with chronic kidney disease based on the Integrated Theory of Health Behavior Change.

This study was a quasi-experiment study. We included 76 adolescents with chronic kidney disease, and based on their willingness to undergo transition intervention, participants were assigned to either the intervention group or the control group. The intervention group received the transition intervention guided by the Integrated Theory of Health Behavior Change, while the control group received standard care and education, remaining unaware of the intervention group’s existence. The data of the intervention group were collected before and after the intervention. Because the total intervention lasted approximately 4 weeks, the data of the control group were collected at baseline (T0) and 1 month (T1). We chose transition readiness as the primary outcome. The secondary outcomes included medication adherence and self-efficacy.

At the final assessment (T1), the scores related to transition readiness, medication adherence, self-care self-efficacy, and adolescent exercise and eating behavior self-efficacy in the intervention group were significantly higher than those in the control group (P < 0.05). Compared with those at T0, the scores of all the constructs in the intervention group increased at T1, and these differences were statistically significant. There was a weak positive correlation between participants’ transition readiness and their medication adherence (r = 0.389, P < 0.01), self-care self-efficacy (r = 0.501, P < 0.01), exercise behavior self-efficacy (r = 0.237, P < 0.05), and eating behavior self-efficacy (r = 0.481, P < 0.01).

Based on the Integrated Theory of Health Behavior Change, the transition program for adolescents with chronic kidney disease significantly improved participants’ transition readiness, self-care self-efficacy, and exercise and eating behavior self-efficacy. While the study’s design limits definitive conclusions on the program’s impact on medication adherence, the observed improvements suggest that potential benefits warrant further investigation.

The study obtained approval from the local institutional review board and was registered on https://www.chictr.org.cn (Clinical Trial Number: ChiCTR2300077149) prior to the enrollment of the first subject on October 31, 2023.

Chronic kidney disease (CKD) is a progressive disease that seriously affects the normal growth and development of children. CKD tends to progress more rapidly, particularly during adolescence. Changes in weight and hormones may lead to a sharp decline in kidney function, even progressing to chronic renal failure (CRF) [1]. A multi-center study in China showed that most children diagnosed with CRF are over 10 years old, and once childhood CKD progresses to CRF, the mortality rate significantly increases [2]. Additionally, in China, most adolescents with CKD receive care in pediatric hospitals while transitioning from parental care to independent self-management. They have not fully assumed responsibility for self-care and lack adequate risk assessment for health management, which may lead to unhealthy behaviors, accelerating the progression of CKD [3]. Upon reaching adulthood, these patients are required to transition to adult hospitals for continued care. However, this process is complicated by the absence of standardized referral protocols and disparities in coverage and reimbursement policies between pediatric and adult patients in China, which may complicate the transition process and disrupt the continuity of care [4]. Therefore, implementing transition readiness interventions for adolescents with CKD has become an indispensable part of their complex medical care. Such interventions not only promote continuity of care but also effectively improve adolescents’ perceptions and experiences of self-care for chronic diseases, enhance their enthusiasm for self-care, and delay the progression of CKD [5]. Currently, guidelines and consensuses recommend providing adequate health education to children during the transition period, helping them understand their condition and treatment details, and guiding them in self-monitoring and health management to promote their transition readiness and self-management skills for a better transition to adult care [6,7,8,9]. However, existing guidelines have not proposed specific systematic improvement plans for transitional preparedness for adolescents with CKD. A recent systematic review [10] has shown the uneven effectiveness of these interventions. The development of interventions based on relevant theories is currently advocated. Improving theories can help decision-makers understand the mechanisms and pathways of interventions [11].

The Integrated Theory of Health Behavior Change (ITHBC) is a patient-centered, dynamic integrative theoretical model that helps healthcare professionals understand patients’ behavior change processes and provides structured guidance to enhance their self-management. It encompasses three core components: Knowledge and Beliefs, Self-Regulation Skills and Social Promotion [12].

The Knowledge and Beliefs model emphasizes individualized assessment and the provision of self-care knowledge tailored to the patient’s needs. The assessment aims to understand the current stage of the behavior change of patients, including their condition, self-care knowledge, and perceived health beliefs. Health beliefs include self-efficacy for specific health behaviors, outcome expectancy (i.e., whether patients believe that engaging in a certain health behavior will achieve the expected results), and goal congruence (i.e., whether the intervention goals align with the patient’s objectives) [12]. Based on these elements, our study enriched the intervention process and identified transition readiness, self-care self-efficacy, medication adherence, and exercise and eating behavior self-efficacy as outcome indicators. The Self-Regulation Skills model aims to guide patients in implementing behavior change processes in daily life. Six steps are suggested for self-management, and six core skills are needed: planning and acting, problem-solving, self-tailoring, decision-making, forming partnerships with healthcare providers, and utilizing available resources [13]. The Social Promotion model includes social influences (e.g., from healthcare providers, online media) and social support (e.g., informational and material support). It underscores that effective social facilitation significantly enhances patients’ motivation and capacity to adopt and sustain health behaviors. It was pointed out that through these three models, the establishment of and changes in patients’ health behaviors can be promoted in the short term [14]. Therefore, this study was based on an intervention programme guided by the three models proposed by the ITHBC. We initially applied the programme to Chinese adolescents with chronic kidney disease to increase their level of transition readiness and self-efficacy.

This study was a quasi-experiment study. Details are reported in accordance with the template for intervention description and replication (TIDieR) checklist and guide [15]. The study obtained approval from the local institutional review board and was registered on https://www.chictr.org.cn (ChiCTR2300077149) prior to the enrollment of the first subject.

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in China is a tertiary public hospital, which primarily serves patients from central and southern China, covering both urban and rural populations in Wuhan and surrounding areas. Patient demographics are diverse in terms of socioeconomic status and educational background. The pediatric department of Tongji Hospital comprises 768 beds, with a substantial proportion of admissions comprising children with chronic diseases. Among the top five conditions treated in the hospital’s pediatric nephrology, immunology, and cardiology departments, the top three are CKD, including nephrotic syndrome, lupus nephritis, and Henoch-Schonlein purpura nephritis. Approximately 35% of these cases involve children over the age of 12.

We included adolescents with CKD, attending Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in China.

Inclusion criteria: (1) Aged 12–17 years; (2) Diagnosed with chronic kidney disease according to KDIGO guidelines, with a disease duration of more than 3 months; (3) Have access to internet-enabled electronic devices; (4) Be conscious and able to have sufficient literacy, communication, and expression skills.

Exclusion criteria: (1) Having critical life-threatening conditions; (2) Diagnosed with moderate to severe cognitive impairments or other psychological or psychiatric issues requiring immediate attention; (3) Patients who had already received any other transition intervention.

After the patients were admitted, the eligible adolescents were informed about the study by the researcher. The guardians of adolescents who were willing to participate in this study signed informed consent forms, and verbal assent was obtained from these adolescents. Based on their willingness to undergo transition intervention, participants were assigned to either the intervention group or the control group. Those who consented were allocated to the intervention group, while those who declined were assigned to the control group. The intervention group received the transition intervention guided by the ITHBC, while the control group received standard care and education, remaining unaware of the intervention group’s existence. Due to the nature of the nursing interventions, participants and intervention providers cannot be blinded. The intervention group collected data before and after the intervention. Because the total intervention lasted approximately 4 weeks, the data of the control group were collected at baseline (T0) and 1 month (T1). Data analysis was conducted by another researcher who was not involved in the programme.

We adopted a nurse-led health education model. Since nurses interact most frequently with patients, they can also serve as transition coordinators. Disabato et al. agreed that well-trained pediatric nurses play an important role in facilitating the transition of adolescents with chronic kidney disease [16]. Furthermore, although internet-based interventions have advantages in terms of convenience, making it easier to collect data and provide necessary transition information, their remote nature may lead to increased risks of data loss and bias [17, 18]. Therefore, we believe that combining face-to-face and online approaches may be more effective in controlling the loss-to-follow-up rate than a single intervention method. Hence, this study adopted a combined face-to-face and online format to improve participation rates in the intervention programme.

The development of the intervention was followed a rigorous multi-step process, including qualitative research, a literature review, and the Delphi method. These steps ensured the intervention’s relevance by identifying patient needs, synthesizing evidence-based practices, and achieving expert consensus on its key components. A brief summary of the key steps and findings of the development of the intervention programme was included in Supplementary Material S1 to contextualize the intervention outcomes presented in this study.

The intervention group implemented an intervention programme based on the ITHBC. Our programme consisted of both face-to-face and online processes. The intervention was carried out by trained nurses. Prior to its initiation, an expert with teaching certification and clinical teaching experience, along with head nurses, conducted standardized training for the nurses. The training included topics such as transition readiness, patient self-management, educational strategies, and communication skills. Guidance and evaluation were provided through theoretical exams and simulated teaching sessions to ensure that the nurses were fully capable of delivering effective education. Weekly online meetings were held to monitor the implementation of the teaching and address any feedback or issues. One patient corresponded to one nurse. One researcher was responsible for establishing a link with participants and pushing the online resources. The intervention process is shown in Table 1. If the participant did not use WeChat, the researcher would maintain contact with the caregiver, and the caregivers were informed of the intervention process in detail to obtain their support and cooperation to ensure the smooth implementation of the intervention. Five eligible patients were selected for pretesting to evaluate the feasibility of the intervention. In the initial design, the online learning modules were structured so that one chapter would be unlocked each week. However, based on feedback from the pretest participants, it became apparent that adolescents’ preferences and their ability to engage with the content varied significantly. Some adolescents expressed a preference for more flexible access to the learning materials, while others felt that the weekly restriction limited their ability to learn at their own pace. Consequently, we adopted the children’s views and changed the online resource access time from one chapter per week to all chapters all the time, and only sent weekly reminders and quizzes to allow children to participate more flexibly in the learning process.

We chose transition readiness as the primary outcome, which was measured using the Chinese version of the Self-Management and Transition to Adulthood with R(x) = Treatment Questionnaire (STARx-C) [19]. The STARx-C consists of 18 items and uses a 5-point Likert scale, with higher scores indicating better self-care and transition readiness of adolescents. The content validity index for the Chinese version of STARx is 0.92, and it has been used in other studies in China [20]. The Cronbach’s alpha coefficient of the scale in our study was found to be 0.836. The secondary outcomes included medication adherence and self-efficacy. We assessed medication adherence using the Chinese version of the Morisky Medication Adherence Scale (MMAS-8), which has been well validated for use with chronic kidney disease patients in China [21]. In our study, the Cronbach’s alpha coefficient for the MMAS-8 was 0.701. The self-efficacy was assessed by using the Self-Care Self-Efficacy Scale (SCSE) and the Adolescent Exercise Eating Behavior Self-Efficacy Scale. The SCSE has demonstrated cross-cultural applicability in China [22]. The Cronbach’s alpha coefficient for the SCSE in our study was 0.940. The Adolescent Exercise Eating Behavior Self-Efficacy Scale, developed by Liu et al., has been used with adolescents in China. This scale demonstrated a split-half reliability of 0.903 and a test-retest reliability of 0.839 [23]. In our study, the Cronbach’s alpha coefficient for this scale was 0.911.

According to previous studies, the STARx-C score of adolescents without intervention was 61.48 ± 10.79 [19], and the score after intervention was 72 ± 10.79 (1 SD). Two independent samples t-test in PASS15.0 software was applied to estimate the sample size. The selected significance level (α) = 0.05 and power of test (1-β) = 90% were used to calculate the sample size of N1 = N2 = 24 patients in each group, and taking into account the 20% of participants lost to follow-up, we enrolled 60 participants, with 30 cases in each group at least.

All data were checked for accuracy by 2 researchers and statistically analyzed using SPSS26.0 software with a significance level of 0.05 selected. The categorical data were described by frequency and percentile, and the continuous data were described by mean, and standard deviation. Data meeting normality and equality of variances were tested by the two independent samples t-test, otherwise by the Mann-Whitney U test. The categorical data were analyzed by chi-square test or Fisher’s precision probability test. In the intragroup comparisons, the paired-sample t-tests or Wilcoxon analysis were used. An intention-to-treat analysis would be adopted to deal with the missing data. Pearson’s correlation or Spearman’s correlation was used to examine the relationships between changes in STARx-C scores and changes in the secondary outcomes.

We recruited 110 patients and 96 agreed to be enrolled. After the first round of data collection, 4 participants in the intervention group and 16 in the control group withdrew from the study. A total of 76 participants completed the two rounds of data collection, 38 in the intervention group and 38 in the control group. The baseline characteristics of the participants are shown in Table 2. None of the variables were significantly different between the two groups at baseline (P > 0.05).

All participants received bedside health education. In the intervention group, participants received four learning reminder messages as part of the online intervention. Each message required a response to confirm receipt, and all participants in the intervention group had replied “received.” However, we acknowledge that simply responding with “received” does not fully confirm whether participants actually watched the videos. Additionally, there were three participants in the intervention group proactively posed questions via WeChat, and responses were provided promptly.

The results are shown in Table 3. At the final assessment (T1), the STARx-C scores, MMAS-8 scores, SCSE scores, and scores of the adolescent exercise eating behavior self-efficacy scale of the intervention group were significantly higher than those of the control group (P < 0.05). Morever, Compared with those at T0, the scores of all indicators in the intervention group increased at T1, and these differences were statistically significant. In the control group, there were significant differences in the scores of MMAS-8 between T0 and T1, but there were no significant differences in the scores of STARx-C, SCSE and the adolescent exercise eating behavior self-efficacy scale.

Changes in the scores (T1-T0) of the STARx-C followed a normal distribution. Spearman’s correlation analysis was conducted to examine the relationships between changes in the STARx-C score and the other four variables (T1-T0). The analysis results are shown in Table 4. There was a weak positive correlation between participants’ transition readiness and their medication adherence (r = 0.389, P < 0.01), self-care self-efficacy (r = 0.501, P < 0.01), exercise behavior self-efficacy (r = 0.237, P < 0.05), eating behavior self-efficacy (r = 0.481, P < 0.01). Additionally, univariate and multivariate analyses were conducted on baseline variables and STARx-C scores to investigate potential interactions. The results (see Supplementary Material S3 and S4) revealed that the change in STARx-C scores from baseline to post-intervention was significantly smaller in the control group compared to the intervention group. Furthermore, younger patients demonstrated a greater improvement in STARx-C scores after the intervention. No significant associations were found between other clinical variables and changes in STARx-C scores.

This study ultimately implemented a transition programme tailored for adolescents with CKD. The evaluation indicators selected based on the ITHBC, include transition readiness, medication adherence, self-care self-efficacy, and self-efficacy in diet and exercise-related health behaviors. These indicators can reflect patients’ knowledge, beliefs, and self-management abilities to some extent. Each of the four indicators has existing scales with good reliability and validity, aiding nurses in making clear assessments [19, 21, 23, 24]. These findings underscore the critical importance of addressing behavioral factors in transition care. Specifically, the positive impact of the intervention on self-efficacy and adherence highlights that empowering adolescents with knowledge, skills, and motivation is essential for a successful transition, particularly for younger adolescents. From a clinical perspective, education in self-management skills and transition readiness enables the development of individualized care plans tailored to specific challenges, ultimately mitigating the risk of adverse outcomes during the transition to adult care.

Several studies have shown that nurses need to recognize the special needs of adolescents during the transition period for education and resource provision [25,26,27]. In our study, the transition readiness level of the intervention group was higher than that of the control group after completing the intervention.The STARx scores of the intervention group increased from 61.97 ± 1.41 to 74.11 ± 1.20, with the change in scores being statistically significant, aligning with our study hypothesis. It demonstrated the effectiveness of the nurse-led transition education programme in improving transition readiness among adolescents with CKD. Additionally, similar to another study [28], we considered the differences in abilities and transition readiness needs among different age groups and set phased goals for transition readiness based on age. However, we found that age significantly influences the effectiveness of transition interventions, with younger adolescents benefiting more from these interventions. This may be due to younger adolescents’ greater reliance on structured support, as their cognitive, emotional, and social skills are still developing. In this context, interventions that offer systematic education and skills training are likely to facilitate their transition more effectively. In contrast, as older adolescents mature, their willingness and responsiveness to transition preparation tend to decrease. They may also exhibit resistance to change, especially when it involves altering established health behaviors or habits, as they may prefer greater autonomy and the ability to make choices. Therefore, we recommend implementing transition interventions at an earlier stage to provide more support for younger adolescents. Given the potential impact of age on intervention outcomes, future research can examine the role of age in intervention effectiveness through stratified and interaction effect analyses, offering valuable insights for the development of more tailored intervention strategies. In addition, unlike the past study [29], we considered parental involvement. In setting transition goals, we emphasized parental involvement and encouraged parents to participate in health education along with their children. This approach helps avoid conflicts between children and parents’ perspectives and reduces the likelihood of over-protection by parents, thereby enhancing the transition readiness of adolescents [30]. In conclusion, the ITHBC-based transition programme can be beneficial in increasing the level of transition readiness in adolescents with CKD.

The MMAS-8 scores of the intervention group at T1 was significantly higher than that of the control group (P < 0.05), and the scores of the intervention group showed a significant increase from T0 to T1. This indicates that the intervention is more effective than standard care in improving medication adherence among adolescents with CKD. There was a weak positive correlation between transition readiness and medication adherence (r = 0.389, P < 0.01), which is consistent with the findings of the other study [31]. However, although the intervention programme showed a significant improvements in many aspects, there was also significant difference in medication adherence scores between the control group at T0 and T1. This could be because medication adherence is influenced by various complex factors such as individual differences, side effects of medications, and family circumstances [32]. These findings suggest that while short-term transition education programs are helpful for CKD adolescents in some respects, improving medication adherence may require more comprehensive, long-term, and personalized interventions. Moreover, it is necessary to consider the specific circumstances of patients and external environmental factors affecting adherence. More precise research is needed to determine the effectiveness of transition programs in improving medication adherence among adolescents with CKD.

The significant improvement in self-care self-efficacy scores in the intervention group indicated that the ITHBC-based intervention effectively enhanced adolescents’ self-care abilities. This may be due to the ITHBC’s knowledge and belief model. By providing necessary knowledge and information through online resources, bedside education, and our transition education manuals, adolescents’ self-efficacy was strengthened [14]. Additionally, weekly knowledge quizzes online provided regular learning feedback, and the achievement of short-term goals brought satisfaction, promoting the establishment of healthy behaviors. However, there was a positive correlation between transition readiness and chronic disease self-care self-efficacy (r = 0.501, P < 0.01), suggesting that transition readiness is important to self-care self-efficacy. But we cannot ignore that its influencing factors may be more complex [27, 33]. Future research could try to focus on enhancing chronic disease self-care self-efficacy as a means to improve transition readiness.

In terms of the adolescent exercise eating behavior self-efficacy, the intervention group’s exercise and eating behavior self-efficacy scores were both significantly higher than those of the control group at T1 (P < 0.01), indicating that the intervention was somewhat effective in promoting healthy lifestyles among adolescents. Our correlational analysis results also showed that better transition readiness is associated with higher exercise eating behavior self-efficacy. In our program, we encouraged joint participation of families and schools in health management and inform patients about the types of support and assistance they may receive in their daily lives. For instance, when patients return to school after discharge, schools may encourage students to participate in physical activities during breaks but cannot control their consumption of junk food. This also suggests that changes in exercise and eating behaviors may require longer-term interventions and the combined supervision and participation of both schools and parents. Research shows that increasing adolescents’ self-efficacy in health behaviors can enhance their willingness to engage in health care, facilitating a smooth transition to adult care [34]. Future studies should view changes in health-related behaviors as important intervention indicators. Studies should actively conduct knowledge dissemination activities, provide individualized counseling and guidance, and encourage family and school support and supervision during the transition process to improve adolescents’ health behavior-related self-efficacy and promote a smooth transition.

To translate these findings into practical strategies, we propose several actionable recommendations for clinical practice. First, nurse-led education transition programme, such as those based on the ITHBC framework, integrated into routine care can serve as foundational models for improving transition readiness and outcomes. Second, the development of age-appropriate interventions should be prioritized to provide ongoing support for self-management and medication adherence, tailored to the specific needs of adolescents. We still recommend strengthening the design and implementation of mobile health applications or interactive educational modules to motivate adolescents and sustain their active participation. These tools enable health professionals to more effectively facilitate continuous monitoring and provide timely feedback. Lastly, we advocate for policy-level support to standardize transition care practices within healthcare systems. This includes training healthcare providers in transition care principles and integrating transition readiness assessments and self-efficacy evaluations into routine care. By adopting these strategies, healthcare systems will be better equipped to address the unique needs of adolescents with CKD, ultimately improving long-term health outcomes and quality of life.

Based on the Integrated Theory of Health Behavior Change, the transition program for adolescents with chronic kidney disease demonstrated significant improvements in participants’ transition readiness, self-care self-efficacy, and exercise and eating behavior self-efficacy. While the study’s design limits definitive conclusions on the program’s impact on medication adherence, the observed improvements suggest that potential benefits warrant further investigation.

The limitations of this study include its limited sample size, which may not fully represent the experiences of all adolescents with CKD. Additionally, due to difficulties in follow-up, this study focused primarily on the short-term effects of the intervention, and future longitudinal studies should be conducted to verify its long-term impact. Another limitation is the failure to control for certain potential confounding factors, such as family support and economic status. A key limitation also involves the verification of participant engagement, particularly concerning video viewing and quiz participation. Although participants were required to confirm receipt of the reminder messages, this did not guarantee that they actually watched the content online. Moreover, since quiz responses were not mandatory for upload, we were unable to track exact participation rates for the quizzes. Despite these limitations, we provided correct answers and explanations after each quiz.

CKD:

Chronic kidney disease

ITHBC:

Integrated Theory of Health Behavior Change

CRF:

Chronic renal failure

TIDieR:

Template for intervention description and replication

STARx-C:

The Chinese version of the Self-Management and Transition to Adulthood with R(x) = Treatment Questionnaire

MMAS-8:

The Morisky Medication Adherence Scale

SCSE:

The Self Care Self-Efficacy Scale

SD:

Standard Deviation

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Authorship are specified as following: YQY and YGZ framed the ideas and contributed to the design. YJJ and LXY collated the data. YQY and FML analyzed the data. YQY drafted the manuscript. YGZ, FML, YJJ revised the manuscript. All authors contributed to the article and approved the submitted version.

Correspondence to Genzhen Yu.

This study was approved by the Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in China, and the methods were carried out in accordance with the approved guidelines. All the patients have been informed and signed informed consent before the experiments. Informed consent was obtained from the parents or legal guardians of all participants under the age of 16, who provided written consent prior to their inclusion in the study.

Consent for publication was obtained from the participants.

The authors declare no competing interests.

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