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NCT02036892 Clinical Trial

Electronically Connected Health Coaching in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02036892
Other study ID # 13-001
Secondary ID
Status Recruiting
Phase Phase 3
First received January 6, 2014
Last updated January 13, 2014
Start date February 2012
Est. completion date June 2014

Study information
Verified date January 2014
Source York University
Contact Paul Ritvo, PhD
Phone 4165808021
Email pritvo@yorku.ca
Is FDA regulated No
Health authority Canada: Public Health Agency of Canada
Study type Interventional

Clinical Trial 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).

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

Recruitment information / eligibility
Status Recruiting
Enrollment 115
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Type 2 Diabetes

- Fluency in English and/or Spanish

Exclusion Criteria:

- > 75 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle counseling with smartphone
Lifestyle counseling with health promoting smartphone software
• Lifestyle counseling
Lifestyle counseling

Locations
Country Name City State
Canada Black Creek Community Health Centre Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
York University Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c Finger prick A1c test or lab test 6 months follow up from baseline No
Secondary Center for Epidemiological Studies Depression Scale Self report measure of psychological distress 6 months follow up from baseline assessment No
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