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

Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02716064
Acronym
TAPESTRY-CM
Enrollment
30
Registered
2016-03-23
Start date
2014-12-31
Completion date
2015-12-31
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypertension

Keywords

chronic conditions, self-management, PHR

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.

Interventions

BEHAVIORALTAP-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

Sponsors

Ontario Ministry of Health and Long Term Care
CollaboratorOTHER_GOV
McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program12 weeksQualitative measure and chart audit evaluating the experience of all participants in the pilot

Secondary

MeasureTime frameDescription
Extent volunteers needed to facilitate PHR set-up12 weeksQuantitaive 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 patients12 weeksQualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
Experience of enrollment by patients12 weeksQualitative measure - focus groups/interviews with patients
Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling12 weeksQualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
Developmental decision evaluation - I12 weeksmportant 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
Patient interest in digital step tracking devise12 weeksMeasure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026