Effectiveness of the User-Centered "Healthcare CEO" App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Date 2025 Jan 13

PMID 39805107

Authors

Yueh-Tao Chiang

Hsing-Yi Yu

Pei-Kwei Tsay

Chi-Wen Chen

Chi-Wen Chang

Chien-Lung Hsu

Fu-Sung Lo

Philip Moons

Affiliations

Soon will be listed here.

Abstract

Background: Young patients aged 16 to 25 years with type 1 diabetes (T1D) often encounter challenges related to deteriorating disease control and accelerated complications. Mobile apps have shown promise in enhancing self-care among youth with diabetes. However, inconsistent findings suggest that further evidence is necessary to confirm the effectiveness of app-based interventions.

Objective: This study aims to evaluate the effectiveness of the Healthcare CEO app in patients with T1D transitioning from adolescence to early adulthood.

Methods: A 2 arms, double-blind, randomized controlled trial will be conducted over a 9-month period, with strategies designed to enhance treatment fidelity. The study expects to enroll 96 patients with T1D, aged 16 to 25 years. Participants will be randomly assigned to either the experimental or control group through central randomization. The intervention will be implemented using the Healthcare CEO app, which consists of 11 interfaces. The research will compare differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the 2 groups at baseline and 3, 6, and 9 months after intervention. Additionally, changes within the experimental group will be analyzed before and after the intervention.

Results: The study was funded in August 2020. It was originally scheduled from August 2020 to July 2022 but was interrupted by the COVID-19 pandemic after enrolling 38 participants, with preliminary results anticipated for publication by November 2024. Recruitment resumed in August 2023, with findings expected to be finalized by July 2025.

Conclusions: The Healthcare CEO app is a comprehensive solution tailored specifically for individuals with T1D transitioning from adolescence to early adulthood. This innovative app has the potential to improve the quality of care for adolescents with T1D during this critical stage and may serve as valuable evidence in support of app-based intervention strategies.

Trial Registration: ClinicalTrials.gov NCT05022875; https://www.clinicaltrials.gov/study/NCT05022875.

International Registered Report Identifier (irrid): DERR1-10.2196/59871.

References

LaBarbera B, Dvorak J, Zhang Y, Jeter K, Talsania M, Beck J . Diabetes-related events in adolescents and young adults: opportunities for psychosocial interventions. Psychol Health Med. 2019; 24(9):1148-1157. DOI: 10.1080/13548506.2019.1597976. View

Cheng A, Tsui E, Hanley A, Zinman B . Developing a quality of life measure for Chinese patients with diabetes. Diabetes Res Clin Pract. 2000; 46(3):259-67. DOI: 10.1016/s0168-8227(99)00091-1. View

Chavez S, Fedele D, Guo Y, Bernier A, Smith M, Warnick J . Mobile Apps for the Management of Diabetes. Diabetes Care. 2017; 40(10):e145-e146. PMC: 5864023. DOI: 10.2337/dc17-0853. View

Sheen Y, Hsu C, Jiang Y, Huang C, Liu J, Sheu W . Trends in prevalence and incidence of diabetes mellitus from 2005 to 2014 in Taiwan. J Formos Med Assoc. 2019; 118 Suppl 2:S66-S73. DOI: 10.1016/j.jfma.2019.06.016. View

Goyal S, Nunn C, Rotondi M, Couperthwaite A, Reiser S, Simone A . A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017; 5(6):e82. PMC: 5495971. DOI: 10.2196/mhealth.7336. View

Beck J, Zhang Y, Shay C, Muhamedagic C, Sternlof S, Ding K . Diabetes knowledge in young adults: associations with hemoglobin A1C. Fam Syst Health. 2015; 33(1):28-35. DOI: 10.1037/fsh0000101. View

Liu M, Tai Y, Hung W, Hsieh M, Wang R . [Relationships between emotional distress, empowerment perception and self-care behavior and quality of life in patients with type 2 diabetes]. Hu Li Za Zhi. 2010; 57(2):49-60. View

. 14. Children and Adolescents: Standards of Care in Diabetes-2024. Diabetes Care. 2023; 47(Suppl 1):S258-S281. PMC: 10725814. DOI: 10.2337/dc24-S014. View

Harrington K, Shapira A, Volkening L, Butler D, Anderson B, Wasserman R . Associations of diabetes self-management characteristics, HbA1c, and psychosocial outcomes with depressive symptoms in a contemporary sample of adolescents with type 1 diabetes. J Diabetes Complications. 2021; 35(3):107838. PMC: 7870579. DOI: 10.1016/j.jdiacomp.2020.107838. View

10.

Ersig A . An Exploratory Study: Transition to Adulthood for College Students with Type 1 Diabetes and Their Parents. J Pediatr Nurs. 2019; 46:12-17. DOI: 10.1016/j.pedn.2019.01.008. View

11.

Chiang Y, Chang C, Yu H, Tsay P, Lo F, Chen C . Developing the "Healthcare CEO App" for patients with type 1 diabetes transitioning from adolescence to young adulthood: A mixed-methods study. Nurs Open. 2022; 10(3):1755-1766. PMC: 9912449. DOI: 10.1002/nop2.1432. View

12.

Pyatak E, Sequeira P, Whittemore R, Vigen C, Peters A, Weigensberg M . Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabet Med. 2014; 31(12):1615-24. PMC: 4221576. DOI: 10.1111/dme.12485. View

13.

Butler A, Weller B, Yi-Frazier J, Fegan-Bohm K, Anderson B, Pihoker C . Diabetes-Specific and General Life Stress and Glycemic Outcomes in Emerging Adults With Type 1 Diabetes: Is Race/Ethnicity a Moderator?. J Pediatr Psychol. 2017; 42(9):933-940. PMC: 5896631. DOI: 10.1093/jpepsy/jsx092. View

14.

Craig M, Jefferies C, Dabelea D, Balde N, Seth A, Donaghue K . ISPAD Clinical Practice Consensus Guidelines 2014. Definition, epidemiology, and classification of diabetes in children and adolescents. Pediatr Diabetes. 2014; 15 Suppl 20:4-17. DOI: 10.1111/pedi.12186. View

15.

Luo D, Xu J, Cai X, Zhu M, Wang H, Yan D . The effects of family functioning and resilience on self-management and glycaemic control among youth with type 1 diabetes. J Clin Nurs. 2019; 28(23-24):4478-4487. DOI: 10.1111/jocn.15033. View

16.

Stahl-Pehe A, Landwehr S, Lange K, Bachle C, Castillo K, Yossa R . Impact of quality of life (QoL) on glycemic control (HbA1c) among adolescents and emerging adults with long-duration type 1 diabetes: A prospective cohort-study. Pediatr Diabetes. 2017; 18(8):808-816. DOI: 10.1111/pedi.12487. View

17.

Chiang Y, Tsay P, Chen C, Hsu C, Yu H, Chang C . A Delphi Study on the Healthcare Needs of Patients with Type 1 Diabetes during the Transition from Adolescence to Adulthood: Consensus among Patients, Primary Caregivers, and Healthcare Providers. Int J Environ Res Public Health. 2021; 18(13). PMC: 8296953. DOI: 10.3390/ijerph18137149. View

18.

Miller K, Foster N, Beck R, Bergenstal R, DuBose S, DiMeglio L . Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015; 38(6):971-8. DOI: 10.2337/dc15-0078. View

19.

Chiang Y, Yu H, Lo F, Chen C, Huang T, Chang C . Emergence of a butterfly: the life experiences of type 1 diabetes Taiwanese patients during the 16-25 years old transition period. Int J Qual Stud Health Well-being. 2020; 15(1):1748362. PMC: 7178814. DOI: 10.1080/17482631.2020.1748362. View

20.

Veazie S, Winchell K, Gilbert J, Paynter R, Ivlev I, Eden K . Rapid Evidence Review of Mobile Applications for Self-management of Diabetes. J Gen Intern Med. 2018; 33(7):1167-1176. PMC: 6025680. DOI: 10.1007/s11606-018-4410-1. View