Technology-Enabled Collaborative Care for Diabetes and Mental Health

NCT07181863 | Recruiting

• 1 other identifier: 19043
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Managing both type 2 diabetes and mental health challenges can be difficult, and many people do not receive care that supports both. This study looks at how virtual health coaching and support from interdisciplinary care teams can help people better manage their health. The purpose of this study is to test the effectiveness of a virtual health coaching program for adults living with type 2 diabetes and mental health challenges compared to usual care. The Technology-Enabled Collaborative Care for type 2 Diabetes and Mental health (TECC-DM) program includes weekly coaching calls, support from an interdisciplinary care team, and online tools to aid self-management. The findings from this study will be used to help improve services for people who have type 2 diabetes and co-occurring mental health symptoms.

Conditions

Type 2 Diabetes; Mental Health; Diabetes Distress

Keywords

type 2 diabetes; diabetes distress; technology; collaborative care

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Quality of life refers to an individual's overall well-being, encompassing physical, mental, emotional, and social dimensions of health. In this study, it is measured using the EuroQol-5D (EQ-5D), which captures participants' perceptions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 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.

  From baseline to 12 weeks post-intervention and at 6-month follow-up

Secondary Outcomes (6)

• Change in diabetes distress score (Diabetes Distress Scale, DDS)

  From baseline to 12 weeks post-intervention and at 6-month follow-up

• Change in psychological and behavioural health symptoms (Global Appraisal of Individual Needs Short Screener, GAIN-SS)

  From baseline to 12 weeks post-intervention and at 6-month follow-up

• Change in perceived stress score (Perceived Stress Scale, PSS)

  From baseline to 12 weeks post-intervention and at 6-month follow-up

• Change in depressive symptoms (Patient Health Questionnaire, PHQ-9)

  From baseline to 12 weeks post-intervention and at 6-month follow-up

• Change in diabetes self-management (Diabetes Self-Management Questionnaire, DSMQ)

  From baseline to 12 weeks post-intervention and at 6-month follow-up

Study Arms (2)

TECC-DM model

EXPERIMENTAL

Participants (n=80) are randomized to the TECC-DM arm, a 12-week, relation-driven and integrated model of care delivered virtually in addition to usual diabetes care. Weekly 1-hour sessions with a health coach are supported by guidance from an interdisciplinary virtual care team, using phone, text, Zoom, and REDCap. The program follows a structured protocol to ensure fidelity. TECC-DM is designed to improve quality of life (primary outcome) and goals of care (secondary outcomes: mental health, self-management, and physiological indicators).

Behavioral: Health coaching

Educational emails

ACTIVE COMPARATOR

Participants (n=80) receive usual diabetes care, which may include primary or specialist care and community-based supports, with services documented to capture variation. In addition, participants receive 10 standardized educational emails over 12 weeks. This arm provides a structured, fidelity-monitored comparison to TECC-DM.

Other: Educational emails

Interventions

Health coaching BEHAVIORAL

Health coaching is the active component of TECC-DM. In weekly 1-hour sessions, the coach builds a therapeutic relationship, supports goal-setting and behaviour change, addresses mental health needs, coordinates resources, and empowers participants to navigate care. Coaching is delivered according to a standardized protocol, in consultation with the virtual care team, and targets improvements in quality of life and goals of care. Coaches do not provide pharmacological treatment or replace usual diabetes care.

TECC-DM model

Educational emails OTHER

Participants receive usual diabetes care (e.g., primary care, endocrinology, community supports) plus 10 standardized educational emails over 12 weeks, delivered according to a consistent protocol. Unlike TECC-DM, this approach does not involve a therapeutic relationship, health coach, or interdisciplinary care team.

Educational emails

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years old
• Diagnosed with type 2 diabetes (T2D)
• Experiencing mental health challenges, defined as:
• Hospital Anxiety and Depression Scale (HADS) score ≥8 on either subscale OR
• Diabetes Distress Scale (DDS) score ≥2
• Community-living
• Able to communicate verbally in English
• Residing in Ontario during study participation

You may not qualify if:

• Diagnosis of severe mental illness (e.g., schizophrenia, psychotic disorder)

Sponsors & Collaborators

• Diabetes Canada: collaborator
• McMaster University: lead
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (2)

• Vojtila L, Sherifali D, Dragonetti R, Ashfaq I, Veldhuizen S, Naeem F, Agarwal SM, Melamed OC, Crawford A, Gerretsen P, Hahn M, Hill S, Kidd S, Mulsant B, Serhal E, Tackaberry-Giddens L, Whitmore C, Marttila J, Tang F, Ramdass S, Lourido G, Sockalingam S, Selby P. Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2023 Jan 17;12:e39724. doi: 10.2196/39724.

  PMID: 36649068 BACKGROUND

• Sherifali D, Whitmore C, Naeem F, Melamed OC, Dragonetti R, Kouzoukas E, Marttila J, Tang F, Tanzini E, Ramdass S, Selby P. Technology-Enabled Collaborative Care for Type-2 Diabetes and Mental Health (TECC-D): Findings From a Mixed Methods Feasibility Trial of a Responsive Co-Designed Virtual Health Coaching Intervention. Int J Integr Care. 2024 Feb 16;24(1):12. doi: 10.5334/ijic.7608. eCollection 2024 Jan-Mar.

  PMID: 38370569 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Personal Satisfaction; Behavior

Study Officials

• Carly Whitmore, RN PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Kervin, PhD

CONTACT

905 525 9140; kervinl@mcmaster.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: Assistant Professor

Model Details: TECC-DM is a relation-driven, integrated care model delivered through accessible technology (phone, text, Zoom, REDCap). Participants in the experimental group (n=80) meet weekly with a health coach, who supports motivation, goal-setting, behaviour change, and care navigation without providing direct pharmacological care. Coaches identify mental health needs, liaise with an interdisciplinary virtual care team, and map services and referrals. Weekly \~1-hour sessions focus on building therapeutic relationships, prioritizing behaviour change, and enhancing self-management. A virtual care team, comprised of interprofessional healthcare team members, meets with the coach to provide guidance. TECC-DM complements but does not replace usual diabetes care.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 18, 2025
• Study Start: March 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)