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

Hypertension Clinical Trial

— TAPESTRY-CM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716064
• Other study ID #: 14-450
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: September 13, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension
• Metabolic Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Canada	McMaster Family Practice	Hamilton	Ontario
Canada	Stonechurch Family Health Centre (SFHC)	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program	Qualitative measure and chart audit evaluating the experience of all participants in the pilot	12 weeks	No
Secondary	Experience of enrollment by patients	Qualitative measure - focus groups/interviews with patients	12 weeks	No
Secondary	Extent volunteers needed to facilitate PHR set-up	Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries	12 weeks	No
Secondary	Burden on healthcare providers to respond to PHR queries from patients	Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.	12 weeks	No
Secondary	Patient interest in digital step tracking devise	Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.	12 weeks	No
Secondary	Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling	Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;	12 weeks	No
Secondary	Developmental decision evaluation - I	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	12 weeks	No