Electronically Connected Health Coaching in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by York University
Sponsor:
Collaborator:
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Paul Ritvo, York University
ClinicalTrials.gov Identifier:
NCT02036892
First received: January 6, 2014
Last updated: January 13, 2014
Last verified: January 2014

January 6, 2014
January 13, 2014
February 2012
May 2014   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: 6 months follow up from baseline ] [ Designated as safety issue: No ]
Finger prick A1c test or lab test
Same as current
Complete list of historical versions of study NCT02036892 on ClinicalTrials.gov Archive Site
Center for Epidemiological Studies Depression Scale [ Time Frame: 6 months follow up from baseline assessment ] [ Designated as safety issue: No ]
Self report measure of psychological distress
Same as current
Not Provided
Not Provided
 
Electronically Connected Health Coaching in Type 2 Diabetes
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).

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Behavioral: Lifestyle counseling with smartphone
    Lifestyle counseling with health promoting smartphone software
  • Behavioral: Lifestyle counseling
    Lifestyle counseling
  • Experimental: Lifestyle counseling with smartphones
    Lifestyle counseling assisted by smartphones
    Intervention: Behavioral: Lifestyle counseling with smartphone
  • Active Comparator: Lifestyle counseling
    Lifestyle counseling
    Intervention: Behavioral: Lifestyle counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
115
June 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • > 75 years of age
Both
18 Years to 75 Years
No
Contact: Paul Ritvo, PhD 4165808021 pritvo@yorku.ca
Contact: Noah Wayne, MSc 4168897289 noahwayne@gmail.com
Canada
 
NCT02036892
13-001
No
Paul Ritvo, York University
York University
Public Health Agency of Canada (PHAC)
Principal Investigator: Paul Ritvo, PhD York University
York University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP