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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804698
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
El Colegio de Sonora
Information provided by (Responsible Party):
Cecilia B Rosales, University of Arizona

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Framingham cardiovascular disease risk [ Time Frame: 12 months ]
Risk Scores estimate the probability that a person will develop CVD
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
Official Title  ICMJE Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes
  • Cardiovascular Disease
Intervention  ICMJE Behavioral: Education intervention
13-week educational and physical activity intervention
Study Arms  ICMJE
  • Experimental: Meta Salud Diabetes-Intervention
    1. Attend the thirteen weekly educational classes and physical activity group (prior physician approval) that are part of the Meta Salud Diabetes program.
    2. Allow the research staff to collect your cholesterol, glucose, A1c, triglyceride levels, as well as your blood pressure, height, weight, and waist and hip circumference.
    3. Respond to a survey about your nutrition and physical activity habits on three separate occasions (at the start of the 13-week program, just after you finish the program, and nine months after you finish the program).
    4. You may also be invited to participate in a follow-up interview, where you will be asked about your experience during and after the Meta Salud Diabetes program.
    Intervention: Behavioral: Education intervention
  • No Intervention: Meta Salud Diabetes-Comparison Group
    1. Allow the research staff to collect your cholesterol, glucose, A1c, triglyceride levels, as well as your blood pressure, height, weight, and waist and hip circumference.
    2. Respond to a survey about your nutrition and physical activity habits on three separate occasions (you will answer the first survey as soon as you finish reading and agree to participate by signing this form, the second survey will be three months from now, and the third survey will be 12 months from now).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cecilia B Rosales, MD 520-626-3202 crosales@email.arizona.edu
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804698
Other Study ID Numbers  ICMJE 1508040144
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cecilia B Rosales, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE El Colegio de Sonora
Investigators  ICMJE
Principal Investigator: Cecilia B Rosales, MD, MS University of Arizona
PRS Account University of Arizona
Verification Date October 2017

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