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

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TAP-HC-DM
Usual Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring Self-Management, Health Connectors, Volunteers, Technology, Interprofessional team, Chronic disease, Self-efficacy, Patient-centredness, Community Engagement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • McMaster Family Health Practice
  • McMaster University Department of Family Medicine
  • Stonechurch Family Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Usual Care

TAP-HC-DM

Arm 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

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

Outcomes

Primary Outcome Measures

Diabetes self-efficacy
This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.

Secondary Outcome Measures

Self-efficacy in Managing General Chronic Conditions
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
The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire
Assessment of Care for Chronic Conditions
The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items
Patient Empowerment
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
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
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
This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.
Patient Readiness for Change
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
This will be assessed using the Rapid Assessment of Physical Activity (RAPA).

Full Information

First Posted
November 3, 2015
Last Updated
October 2, 2017
Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care, Health Canada, McMaster Family Health Team, Volunteer Hamilton, INSPIRE-PHC
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1. Study Identification

Unique Protocol Identification Number
NCT02715791
Brief Title
TAPESTRY With Health Connnectors for Diabetes Management
Acronym
TAP-HC-DM
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care, Health Canada, McMaster Family Health Team, Volunteer Hamilton, INSPIRE-PHC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypertension
Keywords
Self-Management, Health Connectors, Volunteers, Technology, Interprofessional team, Chronic disease, Self-efficacy, Patient-centredness, Community Engagement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Other
Arm 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
Arm Title
TAP-HC-DM
Arm Type
Other
Arm Description
Patients randomized to the intervention group will get TAP-HC-DM intervention from time zero
Intervention Type
Behavioral
Intervention Name(s)
TAP-HC-DM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes self-efficacy
Description
This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.
Time Frame
4-month
Secondary Outcome Measure Information:
Title
Self-efficacy in Managing General Chronic Conditions
Description
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.
Time Frame
4-month
Title
Attainment of Health Goals
Description
The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire
Time Frame
4-month
Title
Assessment of Care for Chronic Conditions
Description
The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items
Time Frame
4-month
Title
Patient Empowerment
Description
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)
Time Frame
4-month
Title
Patient Centredness
Description
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)
Time Frame
4-month
Title
Satisfaction with Healthcare
Description
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)
Time Frame
4-month
Title
Patient Activation
Description
This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.
Time Frame
4-month
Title
Patient Readiness for Change
Description
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
Time Frame
4-month
Title
Physical Activity
Description
This will be assessed using the Rapid Assessment of Physical Activity (RAPA).
Time Frame
4-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Price, MD, CCFP
Organizational Affiliation
Professor and Chair, McMaster Department of Family Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lisa Dolovich, PharmD, MSc
Organizational Affiliation
Co-Principal Investigator, McMaster Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Family Health Practice
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 1H6
Country
Canada
Facility Name
McMaster University Department of Family Medicine
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 1H6
Country
Canada
Facility Name
Stonechurch Family Health Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8W 3J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31673398
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.
Results Reference
derived

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TAPESTRY With Health Connnectors for Diabetes Management

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