TAPESTRY With Health Connnectors for Diabetes Management

Hypertension Clinical Trial

— TAP-HC-DM  

Official title:

Teams Advancing Patient Experience: Strengthening Quality for People Through Health Connectors for Diabetes Management (TAPESTRY-HC-DM): A Feasibility RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715791
• Other study ID #: 0744
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: October 2, 2017
• Start date: February 2016
• Est. completion date: September 26, 2017

Study information

• Verified date: October 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 26, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• TAP-HC-DM
Patients randomized to the intervention group will complete the Healthy Lifestyle App modules. Their results will create a report with a suggested list of tip sheets that patients, volunteers, and clinics will see. Patients will also be encouraged to access the McMaster PHR in order to track their health, and communicate with volunteers or the clinic. Volunteer health connectors will connect with patients at least weekly, by phone, McMaster PHR message, or in person (depending on patient preference). They will be motivating, providing tip sheets or other education, doing tech support, providing community resources, and building a volunteer-patient relationship with the client. Clinicians will see and triage the reports, and may follow up on various aspects identified.

Other:
• Usual Care
Patients randomized to the control group will receive usual care and upon the end of the intervention arm of the study will receive the TAPESTRY-HC-DM intervention as detailed in the intervention group.

Locations

Country	Name	City	State
Canada	McMaster Family Health Practice	Hamilton	Ontario
Canada	McMaster University Department of Family Medicine	Hamilton	Ontario
Canada	Stonechurch Family Health Centre	Hamilton	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Health Canada, INSPIRE-PHC, McMaster Family Health Team, Ontario Ministry of Health and Long Term Care, Volunteer Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes self-efficacy	This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.	4-month
Secondary	Self-efficacy in Managing General Chronic Conditions	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.	4-month
Secondary	Attainment of Health Goals	The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire	4-month
Secondary	Assessment of Care for Chronic Conditions	The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items	4-month
Secondary	Patient Empowerment	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)	4-month
Secondary	Patient Centredness	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)	4-month
Secondary	Satisfaction with Healthcare	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)	4-month
Secondary	Patient Activation	This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.	4-month
Secondary	Patient Readiness for Change	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	4-month
Secondary	Physical Activity	This will be assessed using the Rapid Assessment of Physical Activity (RAPA).	4-month