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

NCT ID: NCT02370719

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-28

Study Completion Date

2017-10-28

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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Mobile application plus standard of care

Group Type EXPERIMENTAL

Mobile application for diabetes self-management

Intervention Type BEHAVIORAL

Control Group

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile application for diabetes self-management

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MOUNT SINAI HOSPITAL

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Joseph Cafazzo

Senior Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph A Cafazzo, PEng, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27542325 (View on PubMed)

Other Identifiers

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BantII

Identifier Type: -

Identifier Source: org_study_id

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