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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorCentre for Addiction and Mental Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • TECC-T1D3 Program

    Behavioral

    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 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 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Coaching Intervention (TECC-T1D3 Program)Experimental treatment 1 intervention
Group B: Education InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - Recruitment Rate (Both Arms)

The primary outcome in this study is feasibility specifically focusing on process outcomes. This includes assessing recruitment number.

Time frame
Through the study completion, an average of 6 months
2

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.

Time frame
From consent to randomization throughout the study (average of 6 months)
3

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

Time frame
Up to 12-weeks
4

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.

Time frame
Within two weeks post-intervention, after completing the 12-weeks program

Secondary outcomes

1

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.

Time frame
Baseline (Week 1) and Post-Intervention (Week 12)
2

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.

Time frame
Baseline (Week 1) and Post-Intervention (Week 12)
3

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.

Time frame
Baseline (Week 1) and Post-Intervention (Week 12)
4

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.

Time frame
Baseline (Week 1) and Post-Intervention (Week 12)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre for Addiction and Mental Health

Lead sponsor

Brain Canada

Collaborator

Juvenile Diabetes Research Foundation

Collaborator