NCT02746861

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 19, 2016

Last Update Submit

April 19, 2016

Conditions

Diabetes

Keywords

peer mentorpeer supporterpeer coachpeer-to-peer mentoring

Outcome Measures

Primary Outcomes (1)

  • Average reduction in HbA1c from baseline

    6-months

Study Arms (2)

Diabetes Self-Management Support (DSMS)

EXPERIMENTAL

Patient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS).

Behavioral: Peer-Supported DSMS

Usual Care

NO INTERVENTION

Patient continues to receive usual care.

Interventions

Peer-Supported DSMSBEHAVIORAL

Phone, SMS/text, and smartphone-based intervention.

Diabetes Self-Management Support (DSMS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • HbA1c\>9%
  • African American or Hispanic ethnicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InquisitHealth

River Edge, New Jersey, 07661, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ashwin Patel, MD PhD

    Chief Medical Officer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashwin Patel, MD PhD

CONTACT

855-412-1787

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

US(1)