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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Hypertension
• Interventions: Behavioral: TAP-CM Intervention

• Registration Number: NCT02716064
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-03
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-23
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAP-CM Intervention	TAP-CM Intervention	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

Primary Outcome Measures

Name	Time	Method
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program	12 weeks	Qualitative measure and chart audit evaluating the experience of all participants in the pilot

Secondary Outcome Measures

Name	Time	Method
Burden on healthcare providers to respond to PHR queries from patients	12 weeks	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	12 weeks	Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
Extent volunteers needed to facilitate PHR set-up	12 weeks	Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
Developmental decision evaluation - I	12 weeks	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
Experience of enrollment by patients	12 weeks	Qualitative measure - focus groups/interviews with patients
Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling	12 weeks	Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;

Trial Locations

Locations (2)

Stonechurch Family Health Centre (SFHC); 🇨🇦 Hamilton, Ontario, Canada

McMaster Family Practice; 🇨🇦 Hamilton, Ontario, Canada