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

NCT02370719 | Terminated

• 1 other identifier: BantII
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus; Randomized controlled trial; Primary care; Physical activity; Lifestyle; Blood glucose; Mobile health; Hb A1c; Self-management

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline to 12 months

  Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Mobile application plus standard of care

Behavioral: Mobile application for diabetes self-management

Control Group

NO INTERVENTION

Standard of care

Interventions

Mobile application for diabetes self-management BEHAVIORAL

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking individuals
• Diagnosed with non-insulin requiring type 2 diabetes
• Outpatients
• Baseline A1c of 7.5% or higher

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• MOUNT SINAI HOSPITAL: collaborator
• University of Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5T3L9, Canada

Location

Related Publications (1)

• 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.

  PMID: 27542325 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Joseph A Cafazzo, PEng, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Director

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: June 28, 2015
• Primary Completion: October 28, 2017
• Study Completion: October 28, 2017
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

CA (1)