TAPESTRY With Health Connnectors for Diabetes Management

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypertension
• Interventions: Other: Usual Care; Behavioral: TAP-HC-DM

• Registration Number: NCT02715791
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-11-03
• Study Start: 2016-02
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Primary Completion: 2016-12
• Study Completion: 2017-09-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Active patient at McMaster Family Health Team
• Aged 18+
• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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
TAP-HC-DM	TAP-HC-DM	Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero

Primary Outcome Measures

Name	Time	Method
Diabetes self-efficacy	4-month	This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy in Managing General Chronic Conditions	4-month	The outcome will be measured by a 6-item Stanford Self-Efficacy Scale for Managing Chronic Disease. It covers several domains that are common across many chronic diseases, symptom control, role function, emotional functioning and communicating with physicians.
Attainment of Health Goals	4-month	The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire
Assessment of Care for Chronic Conditions	4-month	The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items
Patient Empowerment	4-month	The outcome will be assessed using Patient Empowerment questionnaire, a 5-item survey questionnaire and Canadian Institutes of Health Research (CIHR) Common Indicator for the Community- Based Primary Health Care (CBPHC)
Patient Centredness	4-month	The outcome will be assessed using Patient Centeredness questionnaire, a 6-item questionnaire and CIHR Common Indicator for the Community- Based Primary Health Care (CBPHC)
Satisfaction with Healthcare	4-month	This will be measured using a one item questionnaire that inquires how clients would like to rate the quality of healthcare they received on a scale of 0-100 (0=not satisfied, 100=completely satisfied)
Patient Activation	4-month	This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.
Patient Readiness for Change	4-month	Readiness-for-Change Questionnaire (RCQ) for Diabetes Self-Management will be used to examine the clients' stage of readiness for diabetes management behaviour change (pre-contemplation, contemplation, action, maintenance), developed based on the Cardiovascular Risk Reduction Program Readiness-to-Change Lifestyle Behavior
Physical Activity	4-month	This will be assessed using the Rapid Assessment of Physical Activity (RAPA).

Trial Locations

Locations (3)

McMaster Family Health Practice; 🇨🇦 Hamilton, Ontario, Canada

Stonechurch Family Health Centre; 🇨🇦 Hamilton, Ontario, Canada

McMaster University Department of Family Medicine; 🇨🇦 Hamilton, Ontario, Canada