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Clinical Trials/NCT02804698
NCT02804698
Completed
N/A

Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico

University of Arizona1 site in 1 country518 target enrollmentAugust 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Arizona
Enrollment
518
Locations
1
Primary Endpoint
Framingham cardiovascular disease risk
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This project will look to improve standards of care for diabetic patients by evaluating a program that supports participants in making healthy lifestyle changes.

The program consists of 13 educational sessions that contain information about the prevention and care of diabetes and cardiovascular disease, physical activity, nutrition, community health and emotional well being.

Detailed Description

Researchers propose to address extremely high rates of cardiovascular disease morbidity and mortality in Sonora, Mexico through use of an evidence-based community health worker intervention for adult patients with diabetes who receive care at health centers operated by the Secretaría de Salud, an office of the Mexican government. Researchers will conduct a cluster-randomized trial with a total of 400 patients at 20 health centers to understand whether the 13-week educational intervention, Meta Salud Diabetes, can effectively reduce clinical, behavioral, and psychosocial risk for cardiovascular disease among adults with diabetes. Researchers will also conduct an implementation study that will consist of systematic engagement of local, state and national decision makers to identify barriers, facilitators, and strategies to adopt and integrate community health worker-led cardiovascular disease prevention interventions throughout the 209 health centers in Sonora.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
May 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cecilia B Rosales

Professor, Public Health / Assistant Dean, Phoenix Campus

University of Arizona

Eligibility Criteria

Inclusion Criteria

  • adults ≥18 years old
  • have been diagnosed with controlled or uncontrolled diabetes

Exclusion Criteria

  • \< than 18 years of age
  • not diagnosed with diabetes

Outcomes

Primary Outcomes

Framingham cardiovascular disease risk

Time Frame: 12 months

Risk Scores estimate the probability that a person will develop CVD

Study Sites (1)

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