Impact of Type 2 Diabetes Peer Counseling on Behavioral,... | NCT01299844

Studies
Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos

NCT01299844

Sponsor

University of Connecticut

Status

Completed

Last Update Posted

Feb 18, 2011Estimated

Enrollment

208Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Diabetes Peer Counseling

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

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Apr 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Feb 15, 2011

First Submission Date that Met QC Criteria

Feb 17, 2011

First Posted Date

Feb 18, 2011Estimated

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

Feb 17, 2011

Last Update Posted Date

Feb 18, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of ConnecticutOTHER

Collaborators

Name	Class
Hartford Hospital	OTHER
Hispanic Health Council, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objectives of this study are:

To develop a comprehensive culturally tailored model of diabetes management that integrates the work of community-based peer counselors and clinical specialists into a multi-disciplinary health care team serving the Latino community.
To implement an intervention that provides education and support to Latino adults diagnosed with Type 2 diabetes in both clinical and home settings.
To evaluate this intervention for its impact on program adherence, and improved outcomes sustained over time as reflected by metabolic, clinical, cognitive and behavioral measures.

Detailed Description

A randomized two group longitudinal design with clinical measurements and behavioral assessments collected at baseline, 3,6,12 and 18 months will be used. It is hypothesized that participants in the home-based peer-counseling intervention will have greater reductions and will better maintain their reductions in their HbA1c levels compared to participants in the standard of care hospital based program currently in place. Additional secondary hypotheses state the participants in the home-based peer-counseling intervention will have improved lipid profile values, cholesterol levels, and BMI compared to participants in the standard of care hospital based program.

Participants in the home-based peer-counseling intervention will monitor their glucose more regularly (defined by the mean and variance in number of monitored days per month) than participants in the standard of care hospital based program. Lastly, participants in the home-based peer-counseling intervention will have a higher rate of program participation (defined by adherence to appointments and referrals) and completion than participants in the standard of care hospital based program.

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

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care	No Intervention
Diabetes Peer Counseling	Experimental		Behavioral: Diabetes Peer Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes Peer Counseling	Behavioral	16 Home visits from a bilingual/bicultural diabetes peer counselor.	Diabetes Peer Counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1c		Change in Baseline in HbA1c at 6 Months

Secondary Outcomes

Measure	Description	Time Frame
Diabetes Knowledge Test Score		Change from Baseline in Diabetes Knowledge Test Score at 6 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Latinos older than 21
Diagnosed with type 2 diabetes
Referred to the "Amigos en Salud" program at Hartford Hospital
Residents of Hartford

Exclusion Criteria:

Advanced renal failure
Advanced heart disease
Diagnosis of major psychological disorder or mental condition
Limb amputation(s) that prevent following study's exercise recommendations
Any other health condition that prevents individual from consuming all their meals orally

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rafael Pérez-Escamilla, PhD	University of Connecticut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Connecticut		Storrs	Connecticut	06269-4017	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25125508	Derived	Perez-Escamilla R, Damio G, Chhabra J, Fernandez ML, Segura-Perez S, Vega-Lopez S, Kollannor-Samuel G, Calle M, Shebl FM, D'Agostino D. Impact of a community health workers-led structured program on blood glucose control among latinos with type 2 diabetes: the DIALBEST trial. Diabetes Care. 2015 Feb;38(2):197-205. doi: 10.2337/dc14-0327. Epub 2014 Aug 14.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases