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TAPESTRY With Health Connnectors for Diabetes Management (TAP-HC-DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715791
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Health Canada
McMaster Family Health Team
Volunteer Hamilton
INSPIRE-PHC
Information provided by (Responsible Party):
Gina Agarwal, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Behavioral: TAP-HC-DM Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Teams Advancing Patient Experience: Strengthening Quality for People Through Health Connectors for Diabetes Management (TAPESTRY-HC-DM): A Feasibility RCT
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

TAP-HC-DM
Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero
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.





Primary Outcome Measures :
  1. Diabetes self-efficacy [ Time Frame: 4-month ]
    This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.


Secondary Outcome Measures :
  1. Self-efficacy in Managing General Chronic Conditions [ Time Frame: 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.

  2. Attainment of Health Goals [ Time Frame: 4-month ]
    The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire

  3. Assessment of Care for Chronic Conditions [ Time Frame: 4-month ]
    The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items

  4. Patient Empowerment [ Time Frame: 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)

  5. Patient Centredness [ Time Frame: 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)

  6. Satisfaction with Healthcare [ Time Frame: 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)

  7. Patient Activation [ Time Frame: 4-month ]
    This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.

  8. Patient Readiness for Change [ Time Frame: 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

  9. Physical Activity [ Time Frame: 4-month ]
    This will be assessed using the Rapid Assessment of Physical Activity (RAPA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715791


Locations
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Canada, Ontario
McMaster Family Health Practice
Hamilton, Ontario, Canada, L8P 1H6
McMaster University Department of Family Medicine
Hamilton, Ontario, Canada, L8P 1H6
Stonechurch Family Health Centre
Hamilton, Ontario, Canada, L8W 3J6
Sponsors and Collaborators
McMaster University
Ontario Ministry of Health and Long Term Care
Health Canada
McMaster Family Health Team
Volunteer Hamilton
INSPIRE-PHC
Investigators
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Study Chair: David Price, MD, CCFP Professor and Chair, McMaster Department of Family Medicine
Principal Investigator: Lisa Dolovich, PharmD, MSc Co-Principal Investigator, McMaster Department of Family Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gina Agarwal, Associate Professor, Department of Family Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT02715791    
Other Study ID Numbers: 0744
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gina Agarwal, McMaster University:
Self-Management
Health Connectors
Volunteers
Technology
Interprofessional team
Chronic disease
Self-efficacy
Patient-centredness
Community Engagement
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases