Technology-Enabled Collaborative Care for Diabetes and Mental Health

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes; Mental Health; Diabetes Distress

• Registration Number: NCT07181863
• Lead Sponsor: McMaster University

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life	From baseline to 12 weeks post-intervention and at 6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Change in diabetes distress score (Diabetes Distress Scale, DDS)	From baseline to 12 weeks post-intervention and at 6-month follow-up	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.
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	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.
Change in perceived stress score (Perceived Stress Scale, PSS)	From baseline to 12 weeks post-intervention and at 6-month follow-up	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.
Change in depressive symptoms (Patient Health Questionnaire, PHQ-9)	From baseline to 12 weeks post-intervention and at 6-month follow-up	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).
Change in diabetes self-management (Diabetes Self-Management Questionnaire, DSMQ)	From baseline to 12 weeks post-intervention and at 6-month follow-up	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.
Change in technology-enabled self-management behaviour (Diabetes Self-Management Technology Questionnaire)	From baseline to 12 weeks post-intervention and at 6-month follow-up	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.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada