JMIR Publications

ABSTRACT

Background:

The transition from adolescence to early adulthood is a challenging time for Type 1 diabetes patients, putting them at risk of poor glycemic control. Healthcare support during this period is crucial. Apps can benefit, but tailored solutions are scarce. More investigation is needed to determine the efficacy of mobile apps in supporting Type 1 diabetes care during this phase.

Objective:

This paper describes a protocol to evaluate the effectiveness of the user-centered Healthcare Chief Executive Officer mobile application intervention in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Methods:

A two-arm, parallel-group, double-blind, randomized controlled trial was employed. A 9-month tNinety-six type 1 diabetes patients aged 16–25 are expected to participate in this study. Central randomization will randomly assign participants to the experimental or control group. The Healthcare CEO app consists of 11 interfaces, which include the following functions: data recording, knowledge, communication skills, food swap guide, exercise recommendations, chat room, reminders, and SOS, which will be used as the intervention measure. We will compare the differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the two groups before intervention and at 3, 6, and 9 months post-intervention. The differences between the pre- and post-intervention experimental groups will also be analyzed.

Results:

Data collection for this research began in July 2020 but was temporarily suspended due to the COVID-19 pandemic outbreak. The recruitment of participants resumed in August 2023. The findings will be presented and discussed in detail upon data analysis.

Conclusions:

The Healthcare CEO app differs from current commercially available apps in that it is a multi-functional app developed to address the needs of individuals transitioning from adolescence to early adulthood. Intervention effectiveness can be evaluated objectively by formulating treatment fidelity-enhancing strategies and adopting a rigorous study design. The results of this study are expected to confirm that the Healthcare CEO app is potentially effective in improving disease control, confidence in self-management, self-care behaviors, and QOL, alongside reducing emotional distress in adolescent patients in the transition phase. This may contribute to enhancing the quality of care provided to diabetic adolescents transitioning to early adulthood and serve as evidence to support the use of app-based intervention measures. Clinical Trial: The study has been listed on ClinicalTrials.gov (identifier: NCT05022875)