About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Unable to participate in English language
Unable to participate via telephone or web-conferencing
Trial design
Parallel
Treatments tested in this trial
TECC-T1D3 Program
BehavioralThe 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 communicate with others about T1D, manage stigma and ask for help with diabetes management and iii. Facilitate connections with T1D communities. Participants can choose topics of discussion based on their needs and will be directly supported by the HC and indirectly monitored by VCT.
Education Intervention
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility - Recruitment Rate (Both Arms)
The primary outcome in this study is feasibility specifically focusing on process outcomes. This includes assessing recruitment number.
Feasibility - Engagement Rate (Both Arms)
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)
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)
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.
Secondary outcomes
Quality of Life (Both Arms)
the European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L) scale: This measure will assess overall well-being and satisfaction with life among participants. The scale evaluates five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Unit of Measure: EQ-5D-5L index score. Minimum Value: 0 (the worst possible health state). Maximum Value: 100 (the best possible health state). Interpretation: Higher scores indicate better health-related quality of life.
Self-efficacy (Both Arms)
Diabetes Empowerment Scale - Short Form (DES-SF) Scale: This measure will evaluate participants' beliefs in their ability to effectively manage their diabetes and related challenges. Minimum Value: 1 (low self-efficacy). Maximum Value: 5 (high self-efficacy). Interpretation: Higher scores indicate greater self-efficacy in managing diabetes.
Diabetes Distress (Both Arms)
Type 1 Diabetes Distress Assessment (T1DDAS) Scale: This scale evaluates ten distinct sources of diabetes-related distress. Each source is scored individually by averaging the responses to relevant items. Sources: Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack of Diabetes Resources, Technology Challenges, Burden to Others, Worries About Complications. Minimum Value: 1 (no distress). Maximum Value: 5 (highest distress). Interpretation: Higher scores indicate a greater impact of the source on diabetes distress.
Diabetes Distress (Both Arms)
Problem Areas in Diabetes Scale (PAID-5) Score: This will measure the level of emotional distress and burden associated with living with Type 1 Diabetes. Minimum Value: 0 (no distress). Maximum Value: 20 (high distress). Interpretation: Higher scores indicate greater levels of emotional distress related to diabetes.
Sponsors and contacts
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Centre for Addiction and Mental Health
Lead sponsor
Brain Canada
Collaborator
Juvenile Diabetes Research Foundation
Collaborator