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Evaluate the Value of Telehomecare for Diabetes

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: NCT02813343
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
North York General Hospital
William Osler Health System
St. Joseph's Care Group
Ontario Telemedicine Network (OTN)
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Women's College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: BlueStar app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluate the Value of Telehomecare for Diabetes
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate Treatment Group
The Immediate Treatment group will receive access to the study intervention - BlueStar app, immediately after consenting for a total duration of 6 months.
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.

Delayed Treatment Group
The Delayed Treatment group will receive access to the study intervention - BlueStar app, 3 months after consenting for a total duration of 3 months.
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.




Primary Outcome Measures :
  1. Glucose control (HbA1c levels) [ Time Frame: Baseline, 3 months and 6 months ]
    Change in HbA1c from baseline to 6 months


Secondary Outcome Measures :
  1. Patient reported health outcomes and utilization - ER visit [ Time Frame: Baseline, 3 months and 6 months ]
    a. Emergency department visits for hyper/hypoglycemia

  2. Patient reported health outcomes and utilization - Hypoglycemic episodes [ Time Frame: Baseline, 3 months and 6 months ]
    b. Hypoglycemic episodes

  3. Patient reported health outcomes and utilization - Hospitalizations [ Time Frame: Baseline, 3 months and 6 months ]
    c. Hospitalizations

  4. Patient reported health outcomes and utilization - Physician visits [ Time Frame: Baseline, 3 months and 6 months ]
    d. Physician visits

  5. Patient reported health outcomes and utilization - Med Adherence [ Time Frame: Baseline, 3 months and 6 months ]
    e. Medication Adherence

  6. Patient reported health outcomes and utilization - Blood glucose monitoring [ Time Frame: Baseline, 3 months and 6 months ]
    f. Frequency of blood glucose monitoring

  7. Health system utilization data collected using Institute for Clinical and Evaluative Sciences (ICES). [ Time Frame: 12 to 18 months ]
    This will be collected using the patient OHIP number.

  8. An adapted version of the Mobile App Rating Scale will collected from all participants [ Time Frame: After 3 or 6 months on the app. ]
  9. App utilization data - time of use [ Time Frame: Through study completion, an average of 3 or 6 months ]
    a. Time spent with each use

  10. App utilization data - Frequency of use [ Time Frame: Through study completion, an average of 3 or 6 months ]
    b. Frequency of Utilization (i. Over study period; ii. By app feature; iii. Time of day)

  11. Standardized PROMs/PREMs [ Time Frame: Baseline, 3 months and 6 months for all participants ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults, 18 years or older, currently being treated for Type II diabetes
  2. HgbA1C greater or equal to 8.0% and at least 1.0% above target within the last 3 months
  3. Have a functional email address or be willing to obtain one
  4. Be functional in reading the English language (self reported)

Exclusion Criteria:

  1. Have Type I diabetes or Latent autoimmune diabetes of adults (LADA)
  2. Are on continuous glucose monitoring
  3. Have an insulin pump
  4. Are on dialysis
  5. Are pregnant.
  6. Are unable to use a computer or mobile phone due to severe mental or physical impairment

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): NCT02813343


Locations
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Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
North York General Hospital
William Osler Health System
St. Joseph's Care Group
Ontario Telemedicine Network (OTN)
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Sacha Bhatia, MD, FRCP(C) Women's College Hospital Institute for Health Systems Solutions and Virtual Care (WIHV)
Publications:
Pawson R. The science of evaluation: a realist manifesto. Sage. 2013.
Marchal B, van Belle S, van Olmen J, Hoerée T, Kegels G. Is realist evaluation keepings its promise? A review of published empirical studies in the field of health systems research. Evaluation. 2012;18(2):192-212.
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02813343    
Other Study ID Numbers: REB # 2016-0010-E
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There are agreements in place to share individual participant data between all the study sites and Women's College Hospital
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases