Bridging Gaps, Enhancing Wellbeing: Examining the Effectiveness of the Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-DM) Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of severe mental illness (e.g., schizophrenia, psychotic disorder)
研究组 & 干预措施
TECC-DM model
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).
干预措施: Health coaching (Behavioral)
Educational emails
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.
干预措施: Educational emails (Other)
结局指标
主要结局
Quality of life
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Carly Whitmore
Assistant Professor
McMaster University