Eastern Caribbean Health Outcomes Research Network (ECHORN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01994811
First received: November 19, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition
Cancer
Cardiovascular Disease
Diabetes
Non Communicable Chronic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eastern Caribbean Health Outcomes Research Network (ECHORN)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Development of diabetes


Secondary Outcome Measures:
  • Cardiovascular disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Development of cardiovascular disease


Other Outcome Measures:
  • Cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Development of cancer


Estimated Enrollment: 5500
Study Start Date: April 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We plan to enroll and follow a community-based sample of 1% of the total population of the 4 ECHORN sites combined (total n = 5,500). 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 will comprise 40% of the cohort (n=2200 total), Trinidad and Tobago residents at 30% (n=1650 total), Barbados residents at 20% (n =1100) and the USVI at 10% (n=550).

Criteria

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994811

Contacts
Contact: Terri-Ann M Thompson, Ph.D. 203-785-5233 terri-ann.thompson@yale.edu
Contact: Katina B Gionteris 203-785-3532 katina.gionteris@yale.edu

Locations
Barbados
University of the West Indies, Cave Hill Campus Recruiting
Bridgetown, Barbados, BB 11000
Contact: Peter O Adams, BSc. MBBS DM    246 417 4264      
Principal Investigator: Peter O Adams, BSc. MBBS DM         
Puerto Rico
University of Puerto Rico Medical Sciences Campus Active, not recruiting
San Juan, Puerto Rico, 00936-5067
Trinidad and Tobago
University of the West Indies, St. Augustine Campus Active, not recruiting
St. Augustine, West Indies, Trinidad and Tobago
Virgin Islands (U.S.)
University of the Virgin Islands Recruiting
St. Thomas, Virgin Islands (U.S.), 00802-9990
Contact: Maxine Nunez, DPH, MSN, CNE, RN    340-693-1289      
Principal Investigator: Mazine Nunez, DPH, MSN, CNE, RN         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marcella Nunez-Smith, MD, MHS Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01994811     History of Changes
Other Study ID Numbers: U24MD006938
Study First Received: November 19, 2013
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
cancer
cardiovascular disease
diabetes
non communicable chronic diseases

Additional relevant MeSH terms:
Cardiovascular Diseases
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014