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Clinical Trials/NCT02804698
NCT02804698CompletedNot Applicable

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

University of Arizona1 site in 1 country518 target enrollmentStarted: August 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
518
Locations
1
Primary Endpoint
Framingham cardiovascular disease risk

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecilia B Rosales

Professor, Public Health / Assistant Dean, Phoenix Campus

University of Arizona

Study Sites (1)

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