Eastern Caribbean Health Outcomes Research Network (ECHORN) (ECHORN)
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ClinicalTrials.gov Identifier: NCT01994811 |
Recruitment Status :
Active, not recruiting
First Posted : November 26, 2013
Last Update Posted : January 20, 2021
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Sponsor:
Yale University
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Yale University
Tracking Information | |||||
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First Submitted Date | November 19, 2013 | ||||
First Posted Date | November 26, 2013 | ||||
Last Update Posted Date | January 20, 2021 | ||||
Actual Study Start Date | April 2013 | ||||
Actual Primary Completion Date | June 14, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Diabetes [ Time Frame: 5 years ] Development of diabetes
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Original Primary Outcome Measures |
Diabetes [ Time Frame: 2 years ] Development of diabetes
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Change History | |||||
Current Secondary Outcome Measures |
Cardiovascular disease [ Time Frame: 5 years ] Development of cardiovascular disease
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Original Secondary Outcome Measures |
Cardiovascular disease [ Time Frame: 2 years ] Development of cardiovascular disease
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Current Other Pre-specified Outcome Measures |
Cancer [ Time Frame: 5 years ] Development of cancer
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Original Other Pre-specified Outcome Measures |
Cancer [ Time Frame: 2 years ] Development of cancer
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Descriptive Information | |||||
Brief Title | Eastern Caribbean Health Outcomes Research Network (ECHORN) | ||||
Official Title | Eastern Caribbean Health Outcomes Research Network (ECHORN) | ||||
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. | ||||
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 | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Blood and Saliva samples
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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). | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
3000 | ||||
Original Estimated Enrollment |
5500 | ||||
Estimated Study Completion Date | May 2021 | ||||
Actual Primary Completion Date | June 14, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Barbados, Puerto Rico, Trinidad and Tobago, Virgin Islands (U.S.) | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01994811 | ||||
Other Study ID Numbers | 1108008959 5U24MD006938 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Yale University | ||||
Study Sponsor | Yale University | ||||
Collaborators | National Institute on Minority Health and Health Disparities (NIMHD) | ||||
Investigators |
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PRS Account | Yale University | ||||
Verification Date | January 2021 |