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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Lucy Kervin, PhD contact

416 946 3434

lucy.kervin@utoronto.ca

Canada2 sites, 1 recruiting

  • McMaster University

    Hamilton, Ontario, L8S 4K1

    Active, not recruiting

  • University of Toronto

    Toronto, Ontario

    Lucy Kervin, PhD, 416 946 3434, teccdm@utoronto.ca

    Carly Whitmore, RN PhD

    Recruiting

Other trials in Canada

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.

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 groups in NCT07181863
Study groupRoleWhat they receive
TECC-DM modelExperimentalParticipants (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 emailsActive comparatorParticipants (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.

  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.

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

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted18 Sep 2025
  2. Study start16 Mar 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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 36649068

  • 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.

    PubMed 38370569

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucy Kervin, PhD (416 946 3434, lucy.kervin@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07181863, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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