Clinical trial NCT01299844: Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos
Official title: Impact of Type 2 Diabetes Peer Counseling on Behavioral, Metabolic, and Health Outcomes Among Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
name: Hispanic Health Council, Inc.
First posted: 2011-02-18
Enrollment: 208
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Change in Baseline in HbA1c at 6 Months
Secondary outcomes:
measure: Diabetes Knowledge Test Score
timeFrame: Change from Baseline in Diabetes Knowledge Test Score at 6 Months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Rafael Pérez-Escamilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.