Peer-Supported Diabetes Self-Management Support | NCT02746861

Studies
Peer-Supported Diabetes Self-Management Support

NCT02746861

Sponsor

InquisitHealth, Inc.

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

Peer-Supported DSMS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R43MD009555	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ashwin Patel, Chief Medical Officer, InquisitHealth, Inc.Principal Investigator

Lead Sponsor

InquisitHealth, Inc.OTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Peer-Supported DSMS	Behavioral	Phone, SMS/text, and smartphone-based intervention.	Diabetes Self-Management Support (DSMS)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average reduction in HbA1c from baseline		6-months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ashwin Patel, MD PhD	Contact	855-412-1787

Overall Officials

Name	Affiliation	Role
Ashwin Patel, MD PhD	Chief Medical Officer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
InquisitHealth	Recruiting	River Edge	New Jersey	07661	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided