Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change in HbA1c from baseline to 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention Group
Mobile application plus standard of care
Intervention: Mobile application for diabetes self-management (Behavioral)
Control Group
Standard of care
Outcomes
Primary Outcomes
Change in HbA1c from baseline to 12 months
Time Frame: Baseline, 3, 6, 9 and 12 months
Secondary Outcomes
- Diabetes Distress Scale(Baseline, 6 and 12 months)
- Blood pressure(Baseline, 3, 6, 9 and 12 months)
- Cholesterol (LDL and total)(Baseline, 6 and 12 months)
- Summary of Diabetes Self-Care Activities(Baseline, 6 and 12 months)
- Medication changes(3, 6, 9 and 12 months)
- Weight(Baseline, 3, 6, 9 and 12 months)
- Glycemic excursions(3, 6, 9 and 12 months)
- BMI(Baseline, 3, 6, 9 and 12 months)
- Diabetes Empowerment Scale(Baseline, 6 and 12 months)
Investigators
Joseph Cafazzo
Senior Director
University Health Network, Toronto