TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)
|ClinicalTrials.gov Identifier: NCT02716064|
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Hypertension||Behavioral: TAP-CM Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
Experimental: 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
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
- The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program [ Time Frame: 12 weeks ]Qualitative measure and chart audit evaluating the experience of all participants in the pilot
- Experience of enrollment by patients [ Time Frame: 12 weeks ]Qualitative measure - focus groups/interviews with patients
- Extent volunteers needed to facilitate PHR set-up [ Time Frame: 12 weeks ]Quantitaive 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 patients [ Time Frame: 12 weeks ]Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
- Patient interest in digital step tracking devise [ Time Frame: 12 weeks ]Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
- Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling [ Time Frame: 12 weeks ]Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
- Developmental decision evaluation - I [ Time Frame: 12 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716064
|McMaster Family Practice|
|Hamilton, Ontario, Canada, L8S 1A4|
|Stonechurch Family Health Centre (SFHC)|
|Hamilton, Ontario, Canada, L8W3J6|
|Principal Investigator:||Gina Agarwal, PhD||McMaster University|