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

NCT06804694 | Recruiting

• 1 other identifier: 2024/065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Feasibility - Recruitment Rate (Both Arms)

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

  Through the study completion, an average of 6 months

• 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.

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

• 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

  Up to 12-weeks

• 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.

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

• Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only)

  • The number of sessions completed.

  Up to 12-weeks

• Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only)

  Measurement include: • Number of interaction categorized by the mode of delivery (web-conference, telephone or text message).

  Up to 12-weeks

• Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only)

  • Average time spent by health coach per interaction/session with participants in minutes.

  Up to 12-weeks

Secondary Outcomes (6)

• 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)

• Diabetes Distress (Both Arms)

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

• Diabetes Distress (Both Arms)

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

• Self-reported HbA1C Levels (Both Arms)

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

Study Arms (2)

Coaching Intervention (TECC-T1D3 Program)

EXPERIMENTAL

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.

Behavioral: TECC-T1D3 Program

Education Intervention

ACTIVE COMPARATOR

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.

Other: Education Intervention

Interventions

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.

Coaching Intervention (TECC-T1D3 Program)

Education Intervention OTHER

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.

Education Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Brain Canada: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Publications (1)

• Whitmore C, Mangialardi N, Saiva A, Cafazzo JA, McQuire T, Mytkolli L, St John A, Senior P, Sherifali D, Strudwick G, Selby P. Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol. Digit Health. 2025 Jul 29;11:20552076251365134. doi: 10.1177/20552076251365134. eCollection 2025 Jan-Dec.

  PMID: 40755960 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Peter Selby

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anika Saiva, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: February 3, 2025
• Study Start: November 27, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)