Clinical trial NCT02716064: TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study
Official title: Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: chronic conditions, self-management, PHR
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2016-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
timeFrame: 12 weeks
Secondary outcomes:
measure: Experience of enrollment by patients
timeFrame: 12 weeks
measure: Extent volunteers needed to facilitate PHR set-up
timeFrame: 12 weeks
measure: Burden on healthcare providers to respond to PHR queries from patients
timeFrame: 12 weeks
measure: Patient interest in digital step tracking devise
timeFrame: 12 weeks
measure: Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
timeFrame: 12 weeks
measure: Developmental decision evaluation - I
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Family Practice
state: Ontario
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre (SFHC)
state: Ontario
Study officials:
affiliation: McMaster University
name: Gina Agarwal, PhD
role: PRINCIPAL_INVESTIGATOR
References: