Feasibility and signals of efficacy of the Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress and glycemic levels among Black young adults with type 1 diabetes compared to standard diabetes education: study protocol for a randomized pilot trial
摘要
Diabetes distress, the negative emotional impact of living with diabetes, is associated with suboptimal outcomes, including higher HbA1c, poorer self-management, and reduced quality of life, and contributes to disparities between Black and White patients with type 1 diabetes (T1D). Young adults may be particularly vulnerable to diabetes distress. Young Black adults therefore may benefit from tailored, representative, and inclusive interventions. Yet, few interventions have been designed to center the experiences of diabetes distress among Black young adults with T1D.
MethodsOnTrack, an evidence-based diabetes distress group intervention, was adapted with input from an advisory board comprised of Black young adults to be culturally appropriate for Black young adults (ages 18–30 years) with T1D. The adapted intervention, called Type 1 Diabetes Education and Support (T1DES), will be tested in this pilot randomized trial to assess the feasibility of T1DES in two distinct healthcare systems: an integrated care system and a safety net care system. Participants will be stratified by site and randomized into the intervention condition (T1DES, n = 40, 20 per site) or an attention control condition providing a traditional diabetes education program not focused on distress (StreamLine, n = 40, 20 per site). Both conditions will include five workshop sessions over 3 months. Feasibility outcomes will include an assessment of intervention acceptability, demand, practicality, fidelity, and economic feasibility. Signals of efficacy will be assessed by changes in diabetes distress (self-reported), diabetes management skills (self-reported), and glycemic control (HbA1c) between study arms, which will be collected at baseline and 3 months post intervention and 6 months post intervention.
DiscussionBlack young adults with T1D face unique needs and challenges that need to be considered when providing diabetes support. Interventions that tailor content to represent the experiences of Black young adults have the potential to reduce diabetes distress and HbA1c and improve diabetes management. If successful, the T1DES intervention could be disseminated to support the long-term goal of improving diabetes outcomes and reducing healthcare disparities in this population.
Trial registrationClinicalTrials.gov NCT05735340. Registered on 2023-2-9.
ClinicalTrials.gov NCT06494722. Registered on 2024-7-9.