Clinical trial NCT02370719: 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
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
Randomized controlled trial
Primary care
Physical activity
Lifestyle
Blood glucose
Mobile health
Hb A1c
Self-management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
name: University of Toronto
name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-02-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c from baseline to 12 months
timeFrame: Baseline, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Weight
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Cholesterol (LDL and total)
timeFrame: Baseline, 6 and 12 months
measure: Medication changes
timeFrame: 3, 6, 9 and 12 months
measure: Glycemic excursions
timeFrame: 3, 6, 9 and 12 months
measure: BMI
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Diabetes Distress Scale
timeFrame: Baseline, 6 and 12 months
measure: Diabetes Empowerment Scale
timeFrame: Baseline, 6 and 12 months
measure: Summary of Diabetes Self-Care Activities
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Joseph A Cafazzo, PEng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.