NCT01299844

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
Last Updated

February 18, 2011

Status Verified

February 1, 2011

Enrollment Period

3.3 years

First QC Date

February 15, 2011

Last Update Submit

February 17, 2011

Conditions

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Change in Baseline in HbA1c at 6 Months

Secondary Outcomes (1)

  • Diabetes Knowledge Test Score

    Change from Baseline in Diabetes Knowledge Test Score at 6 Months

Study Arms (2)

Standard Care

NO INTERVENTION

Diabetes Peer Counseling

EXPERIMENTAL
Behavioral: Diabetes Peer Counseling

Interventions

16 Home visits from a bilingual/bicultural diabetes peer counselor.

Also known as: DIALBEST
Diabetes Peer Counseling

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269-4017, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rafael Pérez-Escamilla, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 18, 2011

Study Start

December 1, 2006

Primary Completion

April 1, 2010

Study Completion

September 1, 2010

Last Updated

February 18, 2011

Record last verified: 2011-02

Locations