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TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716064
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Behavioral: TAP-CM Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Experience of enrollment by patients [ Time Frame: 12 weeks ]
    Qualitative measure - focus groups/interviews with patients

  2. 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

  3. 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.

  4. 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.

  5. 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;

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
McMaster Family Practice
Hamilton, Ontario, Canada, L8S 1A4
Stonechurch Family Health Centre (SFHC)
Hamilton, Ontario, Canada, L8W3J6
Sponsors and Collaborators
McMaster University
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Gina Agarwal, PhD McMaster University
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02716064    
Other Study ID Numbers: 14-450
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Keywords provided by McMaster University:
chronic conditions, self-management, PHR
Additional relevant MeSH terms:
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Metabolic Diseases