Clinical trial NCT02715791: TAPESTRY With Health Connnectors for Diabetes Management
Official title: Teams Advancing Patient Experience: Strengthening Quality for People Through Health Connectors for Diabetes Management (TAPESTRY-HC-DM): A Feasibility RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hypertension
Keywords: Self-Management
Health Connectors
Volunteers
Technology
Interprofessional team
Chronic disease
Self-efficacy
Patient-centredness
Community Engagement
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Health Canada
name: McMaster Family Health Team
name: Volunteer Hamilton
name: INSPIRE-PHC
First posted: 2016-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Diabetes self-efficacy
timeFrame: 4-month
Secondary outcomes:
measure: Self-efficacy in Managing General Chronic Conditions
timeFrame: 4-month
measure: Attainment of Health Goals
timeFrame: 4-month
measure: Assessment of Care for Chronic Conditions
timeFrame: 4-month
measure: Patient Empowerment
timeFrame: 4-month
measure: Patient Centredness
timeFrame: 4-month
measure: Satisfaction with Healthcare
timeFrame: 4-month
measure: Patient Activation
timeFrame: 4-month
measure: Patient Readiness for Change
timeFrame: 4-month
measure: Physical Activity
timeFrame: 4-month
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Family Health Practice
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Department of Family Medicine
state: Ontario
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre
state: Ontario
Study officials:
affiliation: Professor and Chair, McMaster Department of Family Medicine
name: David Price, MD, CCFP
role: STUDY_CHAIR
affiliation: Co-Principal Investigator, McMaster Department of Family Medicine
name: Lisa Dolovich, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.