Type 2 DiabetesTECC-DMNCT07181863
Technology-Enabled Collaborative Care for Diabetes and Mental Health
A study testing Health coaching and Educational emails in people with Type 2 Diabetes and Mental Health, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Mental Health, Diabetes Distress
- What is being tested?
- Health coaching and Educational emails
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Mar 2025to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of severe mental illness (e.g., schizophrenia, psychotic disorder)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
- Recruiting
University of Toronto
Toronto, Ontario
Lucy Kervin, PhD, 416 946 3434, teccdm@utoronto.ca
Carly Whitmore, RN PhD
About this study
Official title: Bridging Gaps, Enhancing Wellbeing: Examining the Effectiveness of the Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-DM) Model
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.
Read the detailed description
This research will:
Implement and evaluate a relation-driven care solution that integrates physical and mental healthcare for adults living with type 2 diabetes (T2D) and comorbid mental health challenges. Applying the principles of relation-centred care which expands patient-centred care to all team members involved, the TECC-DM model was co-designed to improve collaborative care between and across sectors, settings, and professionals. This model enhances the core relationship between provider and patients while empowering the person to be an active agent in their health and care.
Assess the effectiveness of the TECC-DM intervention (n=80) on patient-relevant (quality of life) and provider-level (satisfaction) outcomes compared to usual care (n=80). Drawing upon established feasibility data, and delivered in addition to existing diabetes care, the TECC-DM model of care may address important health system challenges in primary care, including those related to access, resources, and skill mix, while delivering whole-person care.
Study the implementation of the TECC-DM model alongside its effectiveness. Engaging a partner advisory group, knowledge users, and clinicians reflects the shared values of our team and ensures that this research leverages a wealth of expertise and real-world insights to inform future applications.
- Conditions
- Type 2 Diabetes, Mental Health, Diabetes Distress
- Being tested
- Health coaching, Educational emails
- Keywords
- type 2 diabetes, diabetes distress, technology, collaborative care
- Medical subject headings
- Diabetes Mellitus, Type 2, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
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.
Educational emailsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Educational emails |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The DDS measures the emotional burden, regimen distress, interpersonal distress, and physician distress related to living with diabetes. Scores range from 1-6, with higher scores indicating greater distress. Outcome will be reported as mean change in total and subscale scores from baseline to 12 weeks and 6 months, with the proportion of participants achieving a clinically meaningful reduction (≥0.5 points) also reported.
Measured: 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)
The GAIN-SS is a validated screener for internalizing and externalizing disorders, substance use, and crime/violence problems. Scores range from 0-15 per subscale, with higher scores indicating more symptoms. Outcome will be reported as change in total and domain scores from baseline to 12 weeks and 6 months, along with the number of participants with reduced symptom severity.
Measured: From baseline to 12 weeks post-intervention and at 6-month follow-up
Change in perceived stress score (Perceived Stress Scale, PSS)
The PSS measures the degree to which situations in one's life are appraised as stressful, with scores ranging from 0-40. Higher scores indicate greater perceived stress. Outcome will be reported as change in mean score from baseline to 12 weeks and 6 months, with distribution of participants across mild, moderate, and high stress categories also described.
Measured: From baseline to 12 weeks post-intervention and at 6-month follow-up
Change in depressive symptoms (Patient Health Questionnaire, PHQ-9)
The PHQ-9 measures the presence and severity of depressive symptoms, with scores ranging from 0-27. Higher scores indicate more severe depression. Outcome will be reported as change in mean score from baseline to 12 weeks and 6 months, and the proportion of participants achieving clinically significant improvement (≥5-point reduction or remission, score <5).
Measured: From baseline to 12 weeks post-intervention and at 6-month follow-up
Change in diabetes self-management (Diabetes Self-Management Questionnaire, DSMQ)
The DSMQ assesses key self-management domains including glucose monitoring, medication adherence, diet, and physical activity. Scores range from 0-10, with higher scores indicating more effective self-management. Outcome will be reported as change in total and subscale scores from baseline to 12 weeks and 6 months.
Measured: From baseline to 12 weeks post-intervention and at 6-month follow-up
Change in technology-enabled self-management behaviour (Diabetes Self-Management Technology Questionnaire)
This questionnaire assesses use and integration of diabetes technologies such as continuous glucose monitoring, insulin pumps, and mobile applications. Higher scores indicate more frequent or effective use of technology for self-management. Outcome will be reported as change in mean scores from baseline to 12 weeks and 6 months.
Measured: From baseline to 12 weeks post-intervention and at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start16 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health, Diabetes Canada
- Responsible party
- Principal investigator, Carly Whitmore, University of Toronto
- Investigators
- Carly Whitmore, RN PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181863
- Sponsor's protocol ID
- 19043
- Acronym
- TECC-DM
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of health and mental health information, the risk of re-identification, and ethical requirements under local privacy legislation and research ethics board approvals. Aggregated data may be available upon reasonable request.
Publications
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.
PubMed 36649068Sherifali 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.
PubMed 38370569