Technology-Enabled Collaborative Care for Diabetes and Mental Health

Official title

Bridging Gaps, Enhancing Wellbeing: Examining the Effectiveness of the Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-DM) Model

Overview

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.

Interventions

• Behavioral Health coaching
  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 d
• Other Educational emails
  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.

Primary outcome measures

• Quality of life [Time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up]

Secondary outcome measures (6)

• Change in diabetes distress score (Diabetes Distress Scale, DDS) [Time frame: 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) [Time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up]
• Change in perceived stress score (Perceived Stress Scale, PSS) [Time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up]
• Change in depressive symptoms (Patient Health Questionnaire, PHQ-9) [Time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up]
• Change in diabetes self-management (Diabetes Self-Management Questionnaire, DSMQ) [Time frame: 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) [Time frame: From baseline to 12 weeks post-intervention and at 6-month follow-up]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• McMaster University — Hamilton

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 Mixe PMID 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 PMID 38370569

Identifiers

NCT: NCT07181863 · 19043

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗