- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746861
Peer-Supported Diabetes Self-Management Support (DSMS)
April 19, 2016 updated by: Ashwin Patel, InquisitHealth, Inc.
Web-based Training of Peers to Deliver Diabetes Self-Management Support
The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Not Applicable
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
-
-
New Jersey
-
River Edge, New Jersey, United States, 07661
- Recruiting
- InquisitHealth
-
Contact:
- Ashwin Patel
- Phone Number: 855-412-1787
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes
- HbA1c>9%
- African American or Hispanic ethnicity
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetes Self-Management Support (DSMS)
Patient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS).
|
Phone, SMS/text, and smartphone-based intervention.
|
|
No Intervention: Usual Care
Patient continues to receive usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Average reduction in HbA1c from baseline
Time Frame: 6-months
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashwin Patel, MD PhD, Chief Medical Officer
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
April 1, 2016
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSMS24
- 5R43MD009555 (U.S. NIH Grant/Contract)
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.