Teams Advancing Patient Experience: Strengthening Quality for People Through Health Connectors for Diabetes Management (TAPESTRY-HC-DM): A Feasibility RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Diabetes self-efficacy
研究概览
简要总结
The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by strengthening connections between patients and the primary healthcare system through "health connectors" -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and McMaster Personal Health Record (PHR). It will explore whether strengthening primary care connections across patients, providers, and community organizations through TAPESTRY-HC-DM - i.e., the deployment of volunteer health connectors coordinated by a community organization, the use of the TAPESTRY Healthy Lifestyle e-Application by patients, and care coordination processes by the interprofessional primary healthcare team - can increase self-efficacy in managing chronic conditions.
详细描述
TAP-HC-DM is a feasibility randomized controlled trial (RCT) involving various pieces of intervention and their interactions to form a complex adaptive system. The purpose of the trial is to assess the effectiveness of the intervention not only through evaluating patient outcomes, but also through understanding the process of implementation and its fidelity to core elements.
The trial will be conducted within the McMaster Family Health Team (MFHT) in Hamilton, Ontario. The MFHT consists of two sites, with approximately 30,000 patients, as well as 30 family physicians, 70 family medicine residents, 10 nurse practitioners and other healthcare professionals.
Initial lists of potential participants will be created using an algorithm based on the inclusion criteria that will be run on the clinics' electronic medical records systems, with manual chart audits completed afterwards on an as-needed basis. The family physicians will then be asked to vet this list for further exclusion criteria. Patients from the list will then be sent a package including an invite letter from their family physician and a consent form.
Participants who have consented, will receive a welcome call from volunteers who will then provide detailed description of the program and expectations. The clients will then be invited to sign up for McMaster Personal Health Record (PHR) and asked to complete the modules (Diabetes, Hypertension, Sleep, Exercise, Nutrition, Medications, PHR) on the Healthy Lifestyle app. After completion of the modules, participants will receive a report and suggested tip sheets based on their responses. Volunteers as health connectors will connect with clients weekly, providing motivation, education, tech support, and community connections. The healthcare teams at the clinics will also receive the report and will triage it in their weekly huddles. Any follow-up recommended by the clinics will be communicated to volunteers who will then work with clients on the given recommendations, or directly to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Active patient at McMaster Family Health Team
- •Diagnosis of Diabetes
- •Diagnosis of Hypertension
- •Regular access to a computer
- •And at least ONE of:
- •Uncontrolled HbA1C measures (in the past 6 months, or most recent) - 10
- •Uncontrolled recent blood pressure (in the past 3 months, or most recent) - 140/90 or higher (either number higher)
- •Newly diagnosed with diabetes (diagnosed within 6 months)
- •End-stage organ damage/other complications of diabetes [e.g. renal dysfunction, diabetic neuropathy]
- •Doctor Recommendation
排除标准
- •identified as deceased
- •explicitly stated they do not want to be part of a research project
- •reside in long-term care
- •are receiving end-of-life care
- •directly related to anyone from the McMaster University Department of Family Medicine
- •not a participant in another TAPESTRY project
研究组 & 干预措施
Usual Care
Patients randomized to the control group will receive usual care and upon the end of study will receive access to the Healthy Lifestyle App and the McMaster PHR
干预措施: Usual Care (Other)
TAP-HC-DM
Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero
干预措施: TAP-HC-DM (Behavioral)
结局指标
主要结局
Diabetes self-efficacy
时间窗: 4-month
This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.
次要结局
- Satisfaction with Healthcare(4-month)
- Self-efficacy in Managing General Chronic Conditions(4-month)
- Attainment of Health Goals(4-month)
- Assessment of Care for Chronic Conditions(4-month)
- Patient Empowerment(4-month)
- Patient Centredness(4-month)
- Patient Activation(4-month)
- Patient Readiness for Change(4-month)
- Physical Activity(4-month)
研究者
Gina Agarwal
Associate Professor, Department of Family Medicine
McMaster University