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TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)

Primary Purpose

Diabetes Mellitus, Hypertension

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

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring chronic conditions, self-management, PHR

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients over the age of 55 at the start of the study
  • Patients with both diabetes and hypertension
  • Patients with access to a computer and the internet

Exclusion Criteria:

  • Patient is palliative or receiving end-of-life care
  • Patient is deceased
  • Has explicitly stated that they do not want to be part of a research project
  • Patient resides in long-term care
  • Patient has indicated that they do not want to receive a home visit from trained community volunteers.
  • Patient or family member does not speak English
  • Patient will be out of the country for more than 50% of trial duration
  • Patients without access to a computer with the internet

Sites / Locations

  • McMaster Family Practice
  • Stonechurch Family Health Centre (SFHC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAP-CM Intervention

Arm Description

Patients in this arm will be encouraged to complete the Healthy Lifestyle App modules and use McMaster PHR to self manage their chronic disease. Participants will also be completing the health and life goals using the App. The TAPESTRY-CM reports generated will then be reviewed by the clinic huddle teams

Outcomes

Primary Outcome Measures

The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
Qualitative measure and chart audit evaluating the experience of all participants in the pilot

Secondary Outcome Measures

Experience of enrollment by patients
Qualitative measure - focus groups/interviews with patients
Extent volunteers needed to facilitate PHR set-up
Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
Burden on healthcare providers to respond to PHR queries from patients
Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
Patient interest in digital step tracking devise
Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
Developmental decision evaluation - I
mportant decisions during the TAPESTRY-CM intervention development process that affected initial implementation or changes in delivery of the TAP-CM intervention and what data supported the decisions made. Using a template to record the number and type of decisions, assessed using qualitative and quantitative analysis

Full Information

First Posted
December 3, 2014
Last Updated
September 13, 2016
Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT02716064
Brief Title
TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study
Acronym
TAPESTRY-CM
Official Title
Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
TAPESTRY-CM pilot study is a 12-week pilot test of the TAPESTRY-CM using a web application (APP) to help patient manage their diabetes and hypertension and other chronic conditions by assisting them in setting goals and connecting them to their healthcare team.
Detailed Description
This pilot study is a program evaluation that will employ developmental evaluation techniques to collect qualitative and quantitative data that will be handled, using a sequential explanatory mixed methods approach.Developmental evaluation is particularly useful for pre-formative development of potential scalable interventions. Developmental evaluation tracks and attempts to make sense of what emerges under conditions of complexity, documenting and interpreting the dynamics, interactions, and interdependencies that occur as innovations unfold. It will be helpful to explicitly understand: 1) what important decisions occur during the TAPESTRY-CM intervention development process and; 2) what data have validated those decisions about how the intervention will be structured and delivered. This understanding will provide a basis for describing key decisions and their rationale to our community and to other communities so that they make more informed adaptations to their local context. TAPESTRY-CM has applied the principles of participatory design by engaging community stakeholders to co-create and refine TAPESTRY-CM interventions in the early phases of the project. The use of mixed methods was purposefully chosen for this developmental evaluation. Answering a set of related research questions which included the collecting, analyzing and interpreting of qualitative and quantitative data increases the depth of understanding of results, provides stronger evidence for patterns or themes if data converge, can neutralize or cancel out some of the disadvantages of each method alone, and explicitly recognizes that social phenomena are complex such that varied methods are helpful to best understand these complexities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension
Keywords
chronic conditions, self-management, PHR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP-CM Intervention
Arm Type
Experimental
Arm Description
Patients in this arm will be encouraged to complete the Healthy Lifestyle App modules and use McMaster PHR to self manage their chronic disease. Participants will also be completing the health and life goals using the App. The TAPESTRY-CM reports generated will then be reviewed by the clinic huddle teams
Intervention Type
Behavioral
Intervention Name(s)
TAP-CM Intervention
Intervention Description
The intervention includes: 1) Healthy Lifestyle App Goal Setting and Prioritization and modules, 2) TAP-CM Report triage Huddle with Interprofessional Team 3) The connection of patients to appropriate community resources 4) Volunteer helping with technology use
Primary Outcome Measure Information:
Title
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
Description
Qualitative measure and chart audit evaluating the experience of all participants in the pilot
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Experience of enrollment by patients
Description
Qualitative measure - focus groups/interviews with patients
Time Frame
12 weeks
Title
Extent volunteers needed to facilitate PHR set-up
Description
Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
Time Frame
12 weeks
Title
Burden on healthcare providers to respond to PHR queries from patients
Description
Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
Time Frame
12 weeks
Title
Patient interest in digital step tracking devise
Description
Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
Time Frame
12 weeks
Title
Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
Description
Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
Time Frame
12 weeks
Title
Developmental decision evaluation - I
Description
mportant decisions during the TAPESTRY-CM intervention development process that affected initial implementation or changes in delivery of the TAP-CM intervention and what data supported the decisions made. Using a template to record the number and type of decisions, assessed using qualitative and quantitative analysis
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over the age of 55 at the start of the study Patients with both diabetes and hypertension Patients with access to a computer and the internet Exclusion Criteria: Patient is palliative or receiving end-of-life care Patient is deceased Has explicitly stated that they do not want to be part of a research project Patient resides in long-term care Patient has indicated that they do not want to receive a home visit from trained community volunteers. Patient or family member does not speak English Patient will be out of the country for more than 50% of trial duration Patients without access to a computer with the internet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Agarwal, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Family Practice
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1A4
Country
Canada
Facility Name
Stonechurch Family Health Centre (SFHC)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8W3J6
Country
Canada

12. IPD Sharing Statement

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TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study

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