TAPESTRY With Health Connnectors for Diabetes Management
NCT ID: NCT02715791
Last Updated: 2017-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-29
2017-09-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ontario Ministry of Health and Long Term Care
OTHER_GOV
Health Canada
OTHER_GOV
McMaster Family Health Team
UNKNOWN
Volunteer Hamilton
UNKNOWN
INSPIRE-PHC
UNKNOWN
McMaster University
OTHER
Responsible Party
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Gina Agarwal
Associate Professor, Department of Family Medicine
Principal Investigators
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David Price, MD, CCFP
Role: STUDY_CHAIR
Professor and Chair, McMaster Department of Family Medicine
Lisa Dolovich, PharmD, MSc
Role: PRINCIPAL_INVESTIGATOR
Co-Principal Investigator, McMaster Department of Family Medicine
Locations
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McMaster Family Health Practice
Hamilton, Ontario, Canada
McMaster University Department of Family Medicine
Hamilton, Ontario, Canada
Stonechurch Family Health Centre
Hamilton, Ontario, Canada
Countries
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References
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Agarwal G, Gaber J, Richardson J, Mangin D, Ploeg J, Valaitis R, Reid GJ, Lamarche L, Parascandalo F, Javadi D, O'Reilly D, Dolovich L. Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams. Pilot Feasibility Stud. 2019 Oct 27;5:118. doi: 10.1186/s40814-019-0504-8. eCollection 2019.
Other Identifiers
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0744
Identifier Type: -
Identifier Source: org_study_id