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

NCT ID: NCT02716064

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Diabetes Mellitus; Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TAP-CM Intervention

Intervention Type: BEHAVIORAL

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

Interventions

TAP-CM Intervention

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gina Agarwal, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Family Practice

Hamilton, Ontario, Canada

Stonechurch Family Health Centre (SFHC)

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

14-450

Identifier Type: -

Identifier Source: org_study_id