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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
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Yale University

Tracking Information
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
 (submitted: October 28, 2019)		 Diabetes [ Time Frame: 5 years ]
Development of diabetes
Original Primary Outcome Measures
 (submitted: November 19, 2013)		 Diabetes [ Time Frame: 2 years ]
Development of diabetes
Change History
Current Secondary Outcome Measures
 (submitted: October 28, 2019)		 Cardiovascular disease [ Time Frame: 5 years ]
Development of cardiovascular disease
Original Secondary Outcome Measures
 (submitted: November 19, 2013)		 Cardiovascular disease [ Time Frame: 2 years ]
Development of cardiovascular disease
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2019)		 Cancer [ Time Frame: 5 years ]
Development of cancer
Original Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)		 Cancer [ Time Frame: 2 years ]
Development of cancer
 
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
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and Saliva samples
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
  • Cancer
  • Cardiovascular Disease
  • Diabetes
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.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 28, 2019)		 3000
Original Estimated Enrollment
 (submitted: November 19, 2013)		 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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Yale University
Study Sponsor Yale University
Collaborators National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Marcella Nunez-Smith, MD, MHS Yale School of Medicine
PRS Account Yale University
Verification Date January 2021