NCT05006729

Brief Summary

The University of Texas Health Science Center at San Antonio (UTHSCSA) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an administrative liaison between all of the RURAL study's cores. The SCC schedules, facilitates, and hosts, all RURAL meetings including preparation for Observational Study Monitoring Board (OSMB) meetings, and maintains direct communication with the study's program officers at NHLBI. The SCC monitors the overall progress of RURAL and keeps all RURAL cores abreast of study updates through meetings, emails, newsletters. It also maintains the official RURAL website and serves as an administrator for investigators seeking to collaborate with RURAL through the submission of Ancillary Studies. The SCC will have no direct interaction with any participants, nor will it have access to identifiable data.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5.2 years

First QC Date

August 9, 2021

Last Update Submit

May 13, 2025

Conditions

Keywords

Risk factors for heart diseaseRisk factors for lung diseasePsychosocial factorsFamilial factorsEconomic factorsMobile examination unit (MEU)AlabamaKentuckyLouisianaMississippi

Outcome Measures

Primary Outcomes (2)

  • Risk factors for lung disease in rural areas

    5 years

  • Risk factors for heart disease in rural areas

    5 years

Secondary Outcomes (2)

  • Pulmonary function

    5 years

  • Heart function

    5 years

Study Arms (1)

RURAL cohort study

A longitudinal research project in ten rural counties in Alabama, Kentucky, Louisiana, and Mississippi enrolling approximately 4,600 participants from these communities, examining several different aspects of their health, including heart and lung function.

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Risk Underlying Rural Areas Longitudinal (RURAL) Cohort is a health research project in ten rural counties throughout Alabama, Kentucky, Louisiana, and Mississippi of residents 25-64 years of age.

You may qualify if:

  • Be a resident of specific counties in Alabama, Kentucky, Louisiana, and Mississippi
  • Have resided in the specific county for the past two years and plan to reside at the residence for the next two years
  • Speak English or Spanish

You may not qualify if:

  • Currently incarcerated or institutionalized
  • Currently in hospice care with a terminal illness and less than 6 month life expectancy
  • Being actively treated for cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens will be de-identified. All phenotype and genotype information associated with the biospecimens may be shared in accordance with the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) data repository sharing policies, in which investigators may obtain de-identified and limited data sets via formal agreements.

MeSH Terms

Conditions

Lung DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesCardiovascular Diseases

Study Officials

  • Vasan Ramachandran, MD

    University of Texas Health Science Center San Antonio

    STUDY DIRECTOR
  • Suzanne Judd, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR
  • Paul Targonski, MD PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasan Ramachandran, MD

CONTACT

Rachael Langey, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean School of Public Health

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 16, 2021

Study Start

January 15, 2021

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations