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

McMaster University

Status: Completed

Conditions: Hypertension; Diabetes Mellitus

Treatments: Behavioral: TAP-CM Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02716064

14-450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

TAP-CM Intervention

Experimental group

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

Treatment:

Behavioral: TAP-CM Intervention