Electronically Connected Health Coaching in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lifestyle counseling with smartphone
Lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Type 2 Diabetes
- Fluency in English and/or Spanish
Exclusion Criteria:
- > 75 years of age
Sites / Locations
- Black Creek Community Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifestyle counseling with smartphones
Lifestyle counseling
Arm Description
Lifestyle counseling assisted by smartphones
Lifestyle counseling
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Finger prick A1c test or lab test
Secondary Outcome Measures
Center for Epidemiological Studies Depression Scale
Self report measure of psychological distress
Full Information
NCT ID
NCT02036892
First Posted
January 6, 2014
Last Updated
January 13, 2014
Sponsor
York University
Collaborators
Public Health Agency of Canada (PHAC)
1. Study Identification
Unique Protocol Identification Number
NCT02036892
Brief Title
Electronically Connected Health Coaching in Type 2 Diabetes
Official Title
Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Public Health Agency of Canada (PHAC)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling with smartphones
Arm Type
Experimental
Arm Description
Lifestyle counseling assisted by smartphones
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Lifestyle counseling
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling with smartphone
Intervention Description
Lifestyle counseling with health promoting smartphone software
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Lifestyle counseling
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Finger prick A1c test or lab test
Time Frame
6 months follow up from baseline
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale
Description
Self report measure of psychological distress
Time Frame
6 months follow up from baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Type 2 Diabetes
Fluency in English and/or Spanish
Exclusion Criteria:
> 75 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Wayne, MSc
Phone
4168897289
Email
noahwayne@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Creek Community Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name & Degree
Noah Wayne, MSc
Phone
4168897289
Email
NoahWayne@gmail.com
First Name & Middle Initial & Last Name & Degree
Noah Wayne, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
26441467
Citation
Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
Results Reference
derived
PubMed Identifier
26199275
Citation
Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
Results Reference
derived
Learn more about this trial
Electronically Connected Health Coaching in Type 2 Diabetes
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