Recruiting

Collaborative Care

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06804694

Conditions

Type 1 Diabetes (T1D)

Diabetes Distress

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

TECC-T1D3 Program

Education Intervention

Study Details

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.

Conditions

Type 1 Diabetes (T1D)

Diabetes Distress

Study ID

NCT06804694

Start date

Nov 27, 2024

Status verified date

Jan, 2025

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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 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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anika Saiva, MPH

(416) 535-8501anika.saiva@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Anika Research Coordinator

4165358501anika.saiva@camh.ca

Principal Investigator:

Peter Selby

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Feb 3, 2025

Last verified

Jan, 2025

Keywords

  • Type 1 Diabetes
  • TECC model
  • Diabetes Distress
  • Technology-enabled Care
  • Young adults with T1D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2025-02-03.