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

This study has been completed.
Sponsor:
Collaborators:
Hartford Hospital
Hispanic Health Council, Inc.
Information provided by:
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01299844
First received: February 15, 2011
Last updated: February 17, 2011
Last verified: February 2011
History of Changes

February 15, 2011
February 17, 2011
December 2006
April 2010   (final data collection date for primary outcome measure)
Hemoglobin A1c [ Time Frame: Change in Baseline in HbA1c at 6 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01299844 on ClinicalTrials.gov Archive Site
Diabetes Knowledge Test Score [ Time Frame: Change from Baseline in Diabetes Knowledge Test Score at 6 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos
Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
Behavioral: Diabetes Peer Counseling
16 Home visits from a bilingual/bicultural diabetes peer counselor.
Other Name: DIALBEST
  • No Intervention: Standard Care
  • Experimental: Diabetes Peer Counseling
    Intervention: Behavioral: Diabetes Peer Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
September 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01299844
H05-351
No
Rafael Pérez-Escamilla, Ph.D., Director, Center for Eliminating Health Disparities among Latinos
University of Connecticut
  • Hartford Hospital
  • Hispanic Health Council, Inc.
Principal Investigator: Rafael Pérez-Escamilla, PhD University of Connecticut
University of Connecticut
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP