Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Mobile application for diabetes self-management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Mobile application plus standard of care | Behavioral: Mobile application for diabetes self-management<br> <br> |
| No Intervention: Control Group<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to 12 months |  | Baseline, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Baseline, 3, 6, 9 and 12 months | 
| Weight |  | Baseline, 3, 6, 9 and 12 months | 
| Cholesterol (LDL and total) |  | Baseline, 6 and 12 months | 
| Medication changes |  | 3, 6, 9 and 12 months | 
| Glycemic excursions |  | 3, 6, 9 and 12 months | 
| BMI |  | Baseline, 3, 6, 9 and 12 months | 
| Diabetes Distress Scale |  | Baseline, 6 and 12 months | 
| Diabetes Empowerment Scale |  | Baseline, 6 and 12 months | 
| Summary of Diabetes Self-Care Activities |  | Baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hb A1c, Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Self-management