TAPESTRY With Health Connnectors for Diabetes Management (TAP-HC-DM)
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|ClinicalTrials.gov Identifier: NCT02715791|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hypertension||Behavioral: TAP-HC-DM Other: Usual Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero
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.
- 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.
- 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.
- Attainment of Health Goals [ Time Frame: 4-month ]The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire
- 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
- 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)
- 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)
- 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)
- Patient Activation [ Time Frame: 4-month ]This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.
- 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
- Physical Activity [ Time Frame: 4-month ]This will be assessed using the Rapid Assessment of Physical Activity (RAPA).
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
|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|
|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|