Evaluate the Value of Telehomecare for Diabetes

NCT02813343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2017-09-14

No results posted yet for this study

Summary

This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 300 participants that are randomized to an immediate treatment group or a delayed intervention group. The primary outcomes include changes in HbA1c and patient reported outcomes and experience measures. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.

Conditions

Interventions

DEVICE

BlueStar app

BlueStar is a smart-phone enabled application that is designed to serve as a virtual coach for patients. The app sends daily evidence-based, real-time messages as well as longitudinal feedback on how to improve diabetes management. The Bluestar app has been shown to be effective at teaching patients about dietary impacts on their blood glucose levels, encouraging patients to generate higher-quality blood glucose data for enhanced self-monitoring, and to improve overall management of diabetes as represented by reductions in levels of HgbA1c. Benefits have been demonstrated in time periods as brief as three months. One US based study showed a decrease in hospitalizations and emergency department visits among participants who use the application.

Sponsors & Collaborators

  • North York General Hospital

    collaborator OTHER
  • William Osler Health System

    collaborator OTHER
  • St. Joseph's Care Group

    collaborator OTHER
  • Ontario Telemedicine Network (OTN)

    collaborator UNKNOWN
  • Unity Health Toronto

    collaborator OTHER
  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Sacha Bhatia, MD, FRCP(C) · Women's College Hospital Institute for Health Systems Solutions and Virtual Care (WIHV)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02813343 on ClinicalTrials.gov