NCT02716064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

December 3, 2014

Last Update Submit

September 13, 2016

Conditions

Keywords

chronic conditions, self-management, PHR

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Experience of enrollment by patients

    12 weeks

  • Extent volunteers needed to facilitate PHR set-up

    12 weeks

  • Burden on healthcare providers to respond to PHR queries from patients

    12 weeks

  • Patient interest in digital step tracking devise

    12 weeks

  • Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

TAP-CM Intervention

EXPERIMENTAL

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

Interventions

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

TAP-CM Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster Family Practice

Hamilton, Ontario, L8S 1A4, Canada

Location

Stonechurch Family Health Centre (SFHC)

Hamilton, Ontario, L8W3J6, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionChronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gina Agarwal, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

March 23, 2016

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations