A multi-center pediatric to adult care transition intervention program to improve clinic visit adherence and clinical outcomes among adolescents and emerging adults with type 1 diabetes mellitus [PATHWAY]: Protocol for a randomized controlled trial

Objective: This multi-center randomized controlled trial aims to evaluate the effectiveness of a context-specific transition intervention program to improve clinic visit adherence and clinical outcomes among emerging adults with type 1 diabetes mellitus (T1DM) in Delhi, India. Methods: We will recruit patients with T1DM of duration >= 1 year and age 15-19.5 years from the participating pediatric sites. After a baseline assessment and a "basic introductory session", which apprises participants about the concept of transition, study participants (proposed sample size =156) will be randomly allocated into an intervention and control arm. Participants in the intervention arm will receive a structured transition program delivered over 15 months. On the other hand, control arm participants will continue to receive usual care from the pediatric site till the time of transfer to the adult site. The study assessments will be done at baseline, at the time of transfer, and at 1 and 2 years following the transfer. The primary outcome is the difference in clinic attendance rate between intervention and control arms at the end of 1 year post-transfer. The secondary outcomes include the difference in clinic attendance rate at the end of 2 years, the difference in proportion of participants with a minimum of 4 visits in the first follow-up year, and process indicators such as diabetes knowledge and self-management skills, diabetes treatment satisfaction, overall quality of life, diabetes-related distress, hospitalization for acute complications and screening for chronic diabetes complications, and HbA1c. Conclusion: This study will provide important new evidence about a potential strategy to improve clinical care among adolescents and emerging adults with T1DM in lower resource contexts during the vulnerable phase of transition from pediatric to adult healthcare. The trial is registered on the Clinical Trials Registry of India (http://ctri.nic.in) under the CTRI registration number CTRI/2020/10/028379.