NCT06464640

Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program

Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Chang Gung University · Academic / Other
• Sex: All
• Age: 16 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The present study aims to evaluate the intervention effectiveness of the Online Interactive Podcast Program"Living with Type 1 Diabetes to Grown-Up"in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Detailed description

Individuals aged 16-25 with Type 1 Diabetes (T1D) face significant transitional challenges in their lives, with an increased risk of worsening disease management. Addressing these challenges, an interactive podcast program, \"Living with Type 1 Diabetes to Grown-Up\"; is being developed with a one-year grant from the National Science and Technology Council. This continued project will span three years, employing a mixed-method research design for evaluation. Participants will be recruited from pediatric endocrinology and genetics clinics and wards across two medical centers in Northern Taiwan. In line with recommendations from prior reviewers, the study will incorporate a two-phased approach: the first phase is a quantitative study, structured around transitional theory and self-regulation theory using PRIDE steps. It adopts a double-blinded, randomized controlled experimental method with data collector and sham treatment participants blinded. Subjects will be randomly assigned to either the experimental group (N=44) or the active control group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance, confidence in self-management, self-care behaviors, diabetes knowledge, interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods. In the subsequent qualitative phase, 15-20 cases from the experimental group will be selected for in-depth interviews to evaluate the impact of the \" Living with Type 1 Diabetes to GrownUp \" interactive podcast program. The outcomes of this research are anticipated to contribute significantly to the clinical management and technological intervention strategies for T1D adolescents in their transitional phase to adulthood.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"	The podcast content was designed based on the results of previous research.Subjects will be randomly assigned to either the experimental group (N=44) or the comparison group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance,confidence in self-management, self-care behaviors, diabetes knowledge,interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods.
DEVICE	E-book	Participants in the active control group will use Ebook.According to the research results from the project leader\'s app effectiveness evaluation (Chiang, 2020-2022), the e-book did not show significant effects on blood sugar control, disease management confidence, self-care behaviors, disease-related knowledge, or interpersonal distress. Therefore, the active control group received a sham treatment in the form of an e-book. The research team extracted content from the CEO APP e-book, with an expert validity of 0.91, and reorganized it into an electronic health education manual titled \"Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\"

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-06-18
• Last updated: 2024-10-15

Locations

1 site across 1 country: Taiwan