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
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 pote...
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| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000651 |
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| Summary: | 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. |
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| ISSN: | 2451-8654 |