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
BackgroundYoung 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 fi...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2025-01-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e59871 |
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| author | Yueh-Tao Chiang Hsing-Yi Yu Pei-Kwei Tsay Chi-Wen Chen Chi-Wen Chang Chien-Lung Hsu Fu-Sung Lo Philip Moons |
| author_facet | Yueh-Tao Chiang Hsing-Yi Yu Pei-Kwei Tsay Chi-Wen Chen Chi-Wen Chang Chien-Lung Hsu Fu-Sung Lo Philip Moons |
| author_sort | Yueh-Tao Chiang |
| collection | DOAJ |
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BackgroundYoung 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.
ObjectiveThis study aims to evaluate the effectiveness of the Healthcare CEO app in patients with T1D transitioning from adolescence to early adulthood.
MethodsA 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.
ResultsThe 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.
ConclusionsThe 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 RegistrationClinicalTrials.gov NCT05022875; https://www.clinicaltrials.gov/study/NCT05022875
International Registered Report Identifier (IRRID)DERR1-10.2196/59871 |
| format | Article |
| id | doaj-art-4c9b7e7d27ea479f96eff5c066a6872c |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj-art-4c9b7e7d27ea479f96eff5c066a6872c2025-01-13T21:31:53ZengJMIR PublicationsJMIR Research Protocols1929-07482025-01-0114e5987110.2196/59871Effectiveness of the User-Centered “Healthcare CEO” App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled TrialYueh-Tao Chianghttps://orcid.org/0000-0001-5478-2018Hsing-Yi Yuhttps://orcid.org/0000-0003-0132-7753Pei-Kwei Tsayhttps://orcid.org/0000-0003-1749-1419Chi-Wen Chenhttps://orcid.org/0000-0003-0306-1207Chi-Wen Changhttps://orcid.org/0000-0001-8718-7522Chien-Lung Hsuhttps://orcid.org/0000-0003-3105-5939Fu-Sung Lohttps://orcid.org/0000-0002-5548-9611Philip Moonshttps://orcid.org/0000-0002-8609-4516 BackgroundYoung 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. ObjectiveThis study aims to evaluate the effectiveness of the Healthcare CEO app in patients with T1D transitioning from adolescence to early adulthood. MethodsA 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. ResultsThe 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. ConclusionsThe 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 RegistrationClinicalTrials.gov NCT05022875; https://www.clinicaltrials.gov/study/NCT05022875 International Registered Report Identifier (IRRID)DERR1-10.2196/59871https://www.researchprotocols.org/2025/1/e59871 |
| spellingShingle | Yueh-Tao Chiang Hsing-Yi Yu Pei-Kwei Tsay Chi-Wen Chen Chi-Wen Chang Chien-Lung Hsu Fu-Sung Lo Philip Moons 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 JMIR Research Protocols |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://www.researchprotocols.org/2025/1/e59871 |
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