Clinical trial NCT06804694: Technology-Enabled Collaborative Care for Young Adults With Type 1 Diabetes and Diabetes Distress: A Feasibility Trial
Official title: Technology-Enabled Collaborative Care for Young Adults With Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes (T1D)
Diabetes Distress
Keywords: Type 1 Diabetes
TECC model
Diabetes Distress
Technology-enabled Care
Young adults with T1D
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Brain Canada
name: Juvenile Diabetes Research Foundation
First posted: 2025-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility - Recruitment Rate (Both Arms)
timeFrame: Through the study completion, an average of 6 months
measure: Feasibility - Engagement Rate (Both Arms)
timeFrame: From consent to randomization throughout the study (average of 6 months)
measure: Feasibility - Completion of Study Assessments (Both Arms)
timeFrame: Up to 12-weeks
measure: Acceptability - Qualitative (Both Arms)
timeFrame: Within two weeks post-intervention, after completing the 12-weeks program
measure: Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only)
timeFrame: Up to 12-weeks
measure: Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only)
timeFrame: Up to 12-weeks
measure: Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only)
timeFrame: Up to 12-weeks
Secondary outcomes:
measure: Quality of Life (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
measure: Self-efficacy (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
measure: Diabetes Distress (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
measure: Diabetes Distress (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
measure: Self-reported HbA1C Levels (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
measure: Connectedness to Care (Both Arms)
timeFrame: Baseline (Week 1) and Post-Intervention (Week 12)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Peter Selby
role: PRINCIPAL_INVESTIGATOR
References: