Technology-Enabled Collaborative Care for Young Adults With Type 1 Diabetes and Diabetes Distress: A Feasibility Trial

Официальное название

Technology-Enabled Collaborative Care for Young Adults With Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention

Обзор

The goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Through this program, the investigators aim to deliver a collaborative care intervention, featuring a health coach and a virtual care team, designed to help participants manage mental health and overall wellbeing.

Подробное описание

A total of 60 young adults with Type 1 Diabetes (T1D) will be enrolled in the study. Participants will be randomly allocated to either a coaching intervention or an education intervention for 12 weeks. During the 12-week program, participants in the coaching intervention will take part in 8-10 sessions with a health coach, where experiences living with diabetes and goals related to diabetes management, communication with a support system, and overall wellbeing will be discussed. Participants in the education intervention will receive generalized educational messages about diabetes and diabetes distress exclusively via automated emails. Before and after the program, participants will complete surveys to provide an understanding of how diabetes and diabetes-related distress are being managed. After completing the respective interventions, participants will have a one-on-one interview with the research team to discuss their experience with the program and potential areas for improvement.

The goal of the program is to enhance the quality of life for young adults with T1D who experience significant emotional burdens associated with the condition. The study addresses a critical research gap by integrating mental health support with diabetes management, a need historically underserved in healthcare settings. By developing a structured mental health intervention that is accessible and scalable, the study addresses the need for a model of whole-person care that incorporates psychological aspects as part of standard diabetes management. The model of care and findings could potentially be applied to other chronic conditions, broadening the impact of the study beyond diabetes to other areas of chronic disease management.

Вмешательства

• Поведенческое TECC-T1D3 Program
  The TECC-T1D3 program is a twelve-week virtual care intervention designed to support individuals with Type 1 Diabetes (T1D) and Diabetes Distress. The program includes a health coach (HC) and a virtual care team (VCT) of T1D, mental health experts and peer support, offering comprehensive care through various communication channels, including WebEx, phone calls, and text messaging. The program aims to: i. Provide T1D specific mental health and wellbeing support, ii. Provide guidance on how to com
• Другое Education Intervention
  The Education Intervention is a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D.

Первичные конечные точки

• Feasibility - Recruitment Rate (Both Arms) [Срок оценки: Through the study completion, an average of 6 months]
• Feasibility - Engagement Rate (Both Arms) [Срок оценки: From consent to randomization throughout the study (average of 6 months)]
• Feasibility - Completion of Study Assessments (Both Arms) [Срок оценки: Up to 12-weeks]
• Acceptability - Qualitative (Both Arms) [Срок оценки: Within two weeks post-intervention, after completing the 12-weeks program]
• Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only) [Срок оценки: Up to 12-weeks]
• Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only) [Срок оценки: Up to 12-weeks]
• Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only) [Срок оценки: Up to 12-weeks]

Вторичные конечные точки (6)

• Quality of Life (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]
• Self-efficacy (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]
• Diabetes Distress (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]
• Diabetes Distress (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]
• Self-reported HbA1C Levels (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]
• Connectedness to Care (Both Arms) [Срок оценки: Baseline (Week 1) and Post-Intervention (Week 12)]

Критерии участия

Критерии включения

• Young adult (age 18-29 years)
• Resident of Ontario
• Living with a self-reported diagnosis of T1D of at least 1 year
• Individual is community-living (people who live independently in the community and are not residing in a setting that provide institutional care or support)

Критерии исключения

• Unable to participate in English language
• Unable to participate via telephone or web-conferencing

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Centre for Addiction and Mental Health — Toronto

Публикации

• Whitmore C, Mangialardi N, Saiva A, Cafazzo JA, McQuire T, Mytkolli L, St John A, Senior P, Sherifali D, Strudwick G, Selby P. Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol. Digit Health. 2025 Jul 29;11:20552076251365134. doi: 10.1177/20552076251365134. eCollection 2025 Jan-Dec. PMID 40755960

Идентификаторы

NCT: NCT06804694 · 2024/065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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