Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings

Marisa E Hilliard; Wendy Levy; Ruth S Weinstock; Korey K Hood; Paula M Trief; Daniel J DeSalvo; Yuliana Rojas; Kyrah Holland; Aika K Schneider-Utaka; Selma A Alamarie; Lynn Agostini; Se-Kang Kim; Maartje de Wit; Meghan E McGrady; Laurel H Messer; Barbara J Anderson

doi:10.1016/j.conctc.2025.101491

Design of the type 1 diabetes and life (T1DAL) pilot and feasibility study: A brief telehealth intervention targeting health-related quality of life across clinical settings

Contemp Clin Trials Commun. 2025 May 13:45:101491. doi: 10.1016/j.conctc.2025.101491. eCollection 2025 Jun.

Authors

Marisa E Hilliard^{1

2}, Wendy Levy^{1

2}, Ruth S Weinstock³, Korey K Hood⁴, Paula M Trief⁵, Daniel J DeSalvo^{1

2}, Yuliana Rojas^{1

2}, Kyrah Holland^{1

2}, Aika K Schneider-Utaka⁴, Selma A Alamarie⁴, Lynn Agostini³, Se-Kang Kim^{1

2}, Maartje de Wit⁶, Meghan E McGrady^{7

8}, Laurel H Messer^{9

10}, Barbara J Anderson¹

Affiliations

¹ Baylor College of Medicine, Department of Pediatrics, USA.
² Texas Children's Hospital, USA.
³ SUNY Upstate Medical University, Department of Medicine, USA.
⁴ Stanford University School of Medicine, Division of Pediatric Endocrinology and Diabetes, Stanford Diabetes Research Center, USA.
⁵ SUNY Upstate Medical University, Department of Psychiatry and Behavioral Sciences, USA.
⁶ Amsterdam UMC, Location VUMC Amsterdam, the Netherlands.
⁷ Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, USA.
⁸ University of Cincinnati College of Medicine, Department of Pediatrics, USA.
⁹ Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Department of Pediatrics, USA.
¹⁰ Tandem Diabetes, Inc, USA.

Abstract

Background: Type 1 diabetes (T1D) management is demanding and can impact quality of life among persons with diabetes (PWDs) and their family members. Behavioral intervention research has largely focused on adolescents, and previous interventions that have benefitted quality of life have limited potential for implementation in routine care. This trial is piloting a brief behavioral intervention that targets health-related quality of life (HRQOL), which can be implemented with PWDs of all ages in a range of clinical care settings. The aims are to (1) evaluate intervention feasibility and acceptability, (2) explore pre-post change in psychosocial and clinical outcomes, and (3) explore costs related to intervention development and implementation.

Methods: Participants are PWD of all ages who receive T1D care in pediatric subspecialty, adult specialty, and primary care settings (target n = 120, 40/site) and a parent (for children) or partner (for adults). Certified diabetes care and education specialists deliver the intervention during two ∼30-45-min remote sessions over 6 months. In the sessions, interventionists review a "quality of life profile" generated from participants' pre-session responses to a measure of T1D-specific HRQOL, and provide behavioral strategies and resources tailored to their individual strengths and challenges. Feasibility and acceptability data include recruitment/enrollment/retention rates, intervention fidelity, satisfaction surveys, and qualitative interviews. Pre-post measures of psychosocial and clinical outcomes are collected at baseline and 6 months.

Conclusion: This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members, designed for implementation across a range of care settings.

Keywords: Behavioral intervention; Pilot study; Quality of life; Telehealth; Type 1 diabetes.

Grants and funding

K26 DK138332/DK/NIDDK NIH HHS/United States