Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility - Recruitment Rate (Both Arms)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Unable to participate in English language
- •Unable to participate via telephone or web-conferencing
研究组 & 干预措施
Coaching Intervention (TECC-T1D3 Program)
Participants will complete a 12-weeks, virtual, TECC-T1D3 program, delivered through an omnichannel, patient-centered approach, which may include WebEx, phone calls, or text messaging. The participants will complete weekly coaching sessions with the health coach and is indirectly supported by a virtual care team comprised of mental health and T1D experts as well as peer support.
干预措施: TECC-T1D3 Program (Behavioral)
Education Intervention
Participants will receive 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.
干预措施: Education Intervention (Other)
结局指标
主要结局
Feasibility - Recruitment Rate (Both Arms)
时间窗: Through the study completion, an average of 6 months
The primary outcome in this study is feasibility specifically focusing on process outcomes. This includes assessing recruitment number.
Feasibility - Engagement Rate (Both Arms)
时间窗: From consent to randomization throughout the study (average of 6 months)
The primary outcome in this study is feasibility, specifically focusing on process outcomes. This includes percentage of consented participants who proceed to randomization.
Feasibility - Completion of Study Assessments (Both Arms)
时间窗: Up to 12-weeks
Coaching Intervention: Participants attending a minimum of 8 sessions out of a possible maximum of 10 sessions Education Intervention: Participants opening a minimum of 8 emails out of the 10 emails
Acceptability - Qualitative (Both Arms)
时间窗: Within two weeks post-intervention, after completing the 12-weeks program
Participants' perceptions, experiences, and satisfaction with the intervention assessed through post-intervention interviews. Interviews will explore perceived impact on health, motivation, and suggestions for improvement.
Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only)
时间窗: Up to 12-weeks
• The number of sessions completed.
Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only)
时间窗: Up to 12-weeks
Measurement include: • Number of interaction categorized by the mode of delivery (web-conference, telephone or text message).
Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only)
时间窗: Up to 12-weeks
• Average time spent by health coach per interaction/session with participants in minutes.
次要结局
- Diabetes Distress (Both Arms)(Baseline (Week 1) and Post-Intervention (Week 12))
- Quality of Life (Both Arms)(Baseline (Week 1) and Post-Intervention (Week 12))
- Self-efficacy (Both Arms)(Baseline (Week 1) and Post-Intervention (Week 12))
- Self-reported HbA1C Levels (Both Arms)(Baseline (Week 1) and Post-Intervention (Week 12))
- Connectedness to Care (Both Arms)(Baseline (Week 1) and Post-Intervention (Week 12))
研究者
Peter Selby
Senior Scientist
Centre for Addiction and Mental Health