TAPESTRY With Health Connnectors for Diabetes Management

NCT02715791 | Completed

• 1 other identifier: 0744
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension

Keywords

Self-Management; Health Connectors; Volunteers; Technology; Interprofessional team; Chronic disease; Self-efficacy; Patient-centredness; Community Engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Self-efficacy in Managing General Chronic Conditions

  4-month

• Attainment of Health Goals

  4-month

• Assessment of Care for Chronic Conditions

  4-month

• Patient Empowerment

  4-month

• Patient Centredness

  4-month

Study Arms (2)

Usual Care

OTHER

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

TAP-HC-DM

OTHER

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

Behavioral: TAP-HC-DM

Interventions

TAP-HC-DM BEHAVIORAL

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.

TAP-HC-DM

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Ontario Ministry of Health and Long Term Care: collaborator
• Health Canada: collaborator
• McMaster Family Health Team: collaborator
• Volunteer Hamilton: collaborator
• INSPIRE-PHC: collaborator

Study Sites (3)

McMaster Family Health Practice

Hamilton, Ontario, L8P 1H6, Canada

Location

McMaster University Department of Family Medicine

Hamilton, Ontario, L8P 1H6, Canada

Location

Stonechurch Family Health Centre

Hamilton, Ontario, L8W 3J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 31673398 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Price, MD, CCFP

  Professor and Chair, McMaster Department of Family Medicine

  STUDY CHAIR

• Lisa Dolovich, PharmD, MSc

  Co-Principal Investigator, McMaster Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Family Medicine

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: March 22, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: September 26, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)