- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01994811
Eastern Caribbean Health Outcomes Research Network (ECHORN) (ECHORN)
July 13, 2022 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
2961
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bridgetown, Barbados, BB 11000
- University of the West Indies, Cave Hill Campus
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico Medical Sciences Campus
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West Indies
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St. Augustine, West Indies, Trinidad and Tobago
- University of the West Indies, St. Augustine Campus
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Charlotte Amalie, Virgin Islands (U.S.), 00802-9990
- University of the Virgin Islands
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population-based prospective cohort is comprised of adults aged 40 and older living in four countries: Puerto Rico (PR), Barbados (BB), the US Virgin Islands (USVI), and Trinidad and Tobago (TT).
Description
Inclusion Criteria:
- Greater than or equal to 40 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of non-communicable diseases
Time Frame: 5 years
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Prevalence of non-communicable diseases, including cancer, heart disease and diabetes.
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcella Nunez-Smith, MD, MHS, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
June 14, 2018
Study Completion (Actual)
June 14, 2018
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 26, 2013
Study Record Updates
Last Update Posted (Actual)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1108008959
- 5U24MD006938 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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, de-identified, limited ECHORN datasets have been made available for public access.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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