We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified December 2016 by Marcella Nunez-Smith, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01994811
First Posted: November 26, 2013
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Marcella Nunez-Smith, Yale University
  Purpose
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
Cancer Cardiovascular Disease Diabetes

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

Further study details as provided by Marcella Nunez-Smith, Yale University:

Primary Outcome Measures:
  • Diabetes [ Time Frame: 2 years ]
    Development of diabetes


Secondary Outcome Measures:
  • Cardiovascular disease [ Time Frame: 2 years ]
    Development of cardiovascular disease


Other Outcome Measures:
  • Cancer [ Time Frame: 2 years ]
    Development of cancer


Biospecimen Retention:   Samples With DNA
Blood and Saliva samples

Estimated Enrollment: 4400
Study Start Date: April 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We plan to enroll and follow a community-based sample of the 4 ECHORN sites combined (total n = 4,400). 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=1760 total), Trinidad and Tobago residents at 30% (n=1320 total), Barbados residents at 20% (n =880) and the USVI at 10% (n=440).
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994811


Contacts
Contact: Josefa L Martinez, Ph.D. 203-785-3532 josefa.martinez@yale.edu
Contact: Tara Rizzo, MPH tara.rizzo@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 Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Cruz M Nazario, PhD    787-758-2525 ext 1-1429      
Principal Investigator: Cruz M Nazario, PhD         
Trinidad and Tobago
University of the West Indies, St. Augustine Campus Recruiting
St. Augustine, West Indies, Trinidad and Tobago
Contact: Rohan Maharaj, DM, MBBS    868 645 2018      
Principal Investigator: Rohan Maharaj, DM, MBBS         
Virgin Islands (U.S.)
University of the Virgin Islands Recruiting
St. Thomas, Virgin Islands (U.S.), 00802-9990
Contact: Maxine Nunez, DPH, RN    340-693-1289      
Principal Investigator: Mazine Nunez, DPH, RN         
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: Marcella Nunez-Smith, Study Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01994811     History of Changes
Other Study ID Numbers: 5U24MD006938-04 ( U.S. NIH Grant/Contract )
5U24MD006938 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2013
First Posted: November 26, 2013
Last Update Posted: December 13, 2016
Last Verified: December 2016
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.

Keywords provided by Marcella Nunez-Smith, Yale University:
cancer
cardiovascular disease
diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases