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

• ClinicalTrials.gov Identifier: NCT01994811
• Recruitment Status: Active, not recruiting
• First Posted: November 26, 2013
• Last Update Posted: January 20, 2021
• Sponsor: Yale University
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Marcella Nunez-Smith, MD, MHS; Yale School of Medicine

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01994811
• Other Study ID Numbers: 1108008959; 5U24MD006938 ( U.S. NIH Grant/Contract )
• First Posted: November 26, 2013
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

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.

• 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:

Cardiovascular Diseases