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

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McMaster University

Status

Completed

Conditions

Hypertension
Type 2 Diabetes Mellitus

Treatments

Other: Usual Care
Behavioral: TAP-HC-DM

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Usual Care
Other group
Description:
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
Treatment:
Other: Usual Care
TAP-HC-DM
Other group
Description:
Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero
Treatment:
Behavioral: TAP-HC-DM

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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