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Eastern Caribbean Health Outcomes Research Network (ECHORN) (ECHORN)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994811
Recruitment Status : Active, not recruiting
First Posted : November 26, 2013
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The Eastern Caribbean Health Outcomes Research Network (ECHORN) is a collaborative research study that examines the lifestyles, eating habits, and health behaviors associated with cancer, diabetes and heart disease in adult men and women living in the Eastern Caribbean.

Condition or disease
Cancer Cardiovascular Disease Diabetes

Detailed Description:
The Eastern Caribbean Health Outcomes Research Network (ECHORN) has two aims: (1) To form a research collaborative across the Eastern Caribbean islands of Puerto Rico, the U.S. Virgin Islands, Barbados, and Trinidad & Tobago to recruit and follow a community-dwelling adult cohort to estimate the prevalence of known and potential risk factors associated with the development of heart disease, cancer, and diabetes and (2) To enhance health outcomes research leadership capacity in the region through a series of dedicated activities locally and abroad. ECHORN will expand clinical research with racial/ethnic minority populations in a transitioning part of the globe now threatened with an epidemic of noncommunicable chronic diseases (NCD). ECHORN's findings will have direct implications for the health disparities research and policy agenda in the mainland United States. In the long term, the links ECHORN will facilitate with local health policy delegations and global strategic organizational partners will promote the translation of research to improve health outcomes across the region. The collection and storage of biological specimens will also contribute to national biomonitoring projects and has the potential to identify unique risk and protective factors in the development of NCD.

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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eastern Caribbean Health Outcomes Research Network (ECHORN)
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 14, 2018
Estimated Study Completion Date : May 2021



Primary Outcome Measures :
  1. Diabetes [ Time Frame: 5 years ]
    Development of diabetes


Secondary Outcome Measures :
  1. Cardiovascular disease [ Time Frame: 5 years ]
    Development of cardiovascular disease


Other Outcome Measures:
  1. Cancer [ Time Frame: 5 years ]
    Development of cancer


Biospecimen Retention:   Samples With DNA
Blood and Saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We have enrolled and are following a community-based sample of the 4 ECHORN sites combined (total n = 2,957). We seek to populate the cohort to roughly approximate the populations of the participating sites and deliberately oversample from Barbados and the U.S.Virgin Islands(USVI) to maximize sample heterogeneity along race/ethnicity/culture. Puerto Rico residents comprise 26% of the cohort (n=766 total), Trinidad and Tobago residents at 28% (n=829 total), Barbados residents at 34% (n=1009) and the USVI at 12% (n=353).
Criteria

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • English or Spanish language speaking
  • Resident of island at least 10 years
  • Able to provide informed consent
  • Non-institutionalized at the time of data collection
  • Stable contact/residential information
  • No plans to relocate from island within the next 5 years

Exclusion Criteria:

  • Pregnant at time of recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994811


Locations
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Barbados
University of the West Indies, Cave Hill Campus
Bridgetown, Barbados, BB 11000
Puerto Rico
University of Puerto Rico Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Trinidad and Tobago
University of the West Indies, St. Augustine Campus
St. Augustine, West Indies, Trinidad and Tobago
Virgin Islands (U.S.)
University of the Virgin Islands
Charlotte Amalie, Virgin Islands (U.S.), 00802-9990
Sponsors and Collaborators
Yale University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Marcella Nunez-Smith, MD, MHS Yale School of Medicine
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01994811    
Other Study ID Numbers: 1108008959
5U24MD006938 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A Data Access and Scientific Review Committee (DASR), was been established to oversee requests for research collaboration (e.g. ancillary studies, secondary data analyses, etc.) to ensure they are within the scope of ECHORN's research mandate. Per the ECHORN Data Access Policy, data from ECHORN's research studies will be available to only internal ECHORN researchers for up to 3 years post data collection completion. Following that period, de-identified, limited ECHORN datasets will be made available for public access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
cancer
cardiovascular disease
diabetes
Additional relevant MeSH terms:
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Cardiovascular Diseases