Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mobile application for diabetes self-management
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Hb A1c, Self-management
Eligibility Criteria
Inclusion Criteria:
- English-speaking individuals
- Diagnosed with non-insulin requiring type 2 diabetes
- Outpatients
- Baseline A1c of 7.5% or higher
Exclusion Criteria:
- Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
- Diabetes duration <1 year
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Mobile application plus standard of care
Standard of care
Outcomes
Primary Outcome Measures
Change in HbA1c from baseline to 12 months
Secondary Outcome Measures
Blood pressure
Weight
Cholesterol (LDL and total)
Medication changes
Glycemic excursions
BMI
Diabetes Distress Scale
Diabetes Empowerment Scale
Summary of Diabetes Self-Care Activities
Full Information
NCT ID
NCT02370719
First Posted
February 18, 2015
Last Updated
September 2, 2021
Sponsor
University Health Network, Toronto
Collaborators
MOUNT SINAI HOSPITAL, University of Toronto, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02370719
Brief Title
Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes
Official Title
Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the inability to recruit the required number of participants, the study has been terminated.
Study Start Date
June 28, 2015 (undefined)
Primary Completion Date
October 28, 2017 (Actual)
Study Completion Date
October 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
MOUNT SINAI HOSPITAL, University of Toronto, Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Hb A1c, Self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Mobile application plus standard of care
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Mobile application for diabetes self-management
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline to 12 months
Time Frame
Baseline, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Weight
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Cholesterol (LDL and total)
Time Frame
Baseline, 6 and 12 months
Title
Medication changes
Time Frame
3, 6, 9 and 12 months
Title
Glycemic excursions
Time Frame
3, 6, 9 and 12 months
Title
BMI
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Diabetes Distress Scale
Time Frame
Baseline, 6 and 12 months
Title
Diabetes Empowerment Scale
Time Frame
Baseline, 6 and 12 months
Title
Summary of Diabetes Self-Care Activities
Time Frame
Baseline, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking individuals
Diagnosed with non-insulin requiring type 2 diabetes
Outpatients
Baseline A1c of 7.5% or higher
Exclusion Criteria:
Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
Diabetes duration <1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Cafazzo, PEng, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T3L9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27542325
Citation
Goyal S, Lewis G, Yu C, Rotondi M, Seto E, Cafazzo JA. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Aug 19;5(3):e174. doi: 10.2196/resprot.5959.
Results Reference
derived
Learn more about this trial
Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes
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