Electronically Connected Health Coaching in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2014 by York University.
Recruitment status was Recruiting

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

History of Changes

Purpose

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).

Condition	Intervention	Phase
Type 2 Diabetes	Behavioral: Lifestyle counseling with smartphone Behavioral: Lifestyle counseling	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

Further study details as provided by York University:

Primary Outcome Measures:

Hemoglobin A1c [ Time Frame: 6 months follow up from baseline ] [ Designated as safety issue: No ]
Finger prick A1c test or lab test

Secondary Outcome Measures:

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


Estimated Enrollment:	115
Study Start Date:	February 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Lifestyle counseling	Behavioral: Lifestyle counseling Lifestyle counseling

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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

> 75 years of age

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036892

Contacts


Contact: Paul Ritvo, PhD	4165808021	pritvo@yorku.ca
Contact: Noah Wayne, MSc	4168897289	noahwayne@gmail.com

Locations


Canada, Ontario
Black Creek Community Health Centre	Recruiting
Toronto, Ontario, Canada, M3M1A4
Contact: Paul Ritvo, PhD 4165808021 pritvo@yorku.ca
Contact: Noah Wayne, MSc 4168897289 NoahWayne@gmail.com
Sub-Investigator: Noah Wayne, MSc

Sponsors and Collaborators

York University

Public Health Agency of Canada (PHAC)

Investigators


Principal Investigator:	Paul Ritvo, PhD	York University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Paul Ritvo, Associate Professor, School of Kinesiology and Health Science, York University
ClinicalTrials.gov Identifier:	NCT02036892 History of Changes
Other Study ID Numbers:	13-001
Study First Received:	January 6, 2014
Last Updated:	January 13, 2014
Health Authority:	Canada: Public Health Agency of Canada

Keywords provided by York University:


Diabetes

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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