Electronically Connected Health Coaching in Type 2 Diabetes

January 13, 2014 updated by: Paul Ritvo, York University

Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial

Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3.

Exclusion criteria: Axis I and II psychiatric disorders.

Primary outcome: HBA1c at 6 months follow up.

Secondary outcome: Centre for Epidemiological Studies Depression Scale

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3M1A4
        • Recruiting
        • Black Creek Community Health Centre
        • Contact:
        • Sub-Investigator:
          • Noah Wayne, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes
  • Fluency in English and/or Spanish

Exclusion Criteria:

  • > 75 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling with smartphones
Lifestyle counseling assisted by smartphones
Behavioral: Lifestyle counseling with smartphone
Lifestyle counseling with health promoting smartphone software
Active Comparator: Lifestyle counseling
Behavioral: Lifestyle counseling
Lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 6 months follow up from baseline
Finger prick A1c test or lab test
6 months follow up from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies Depression Scale
Time Frame: 6 months follow up from baseline assessment
Self report measure of psychological distress
6 months follow up from baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

York University

Collaborators

Public Health Agency of Canada (PHAC)

Investigators

  • Principal Investigator: Paul Ritvo, PhD, York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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