Risk Underlying Rural Areas Longitudinal Cohort Study (RURAL) Heart and Lung Study

Heart Diseases Clinical Trial

— RURAL  

Official title:

RURAL Study Coordinating Center and Pulmonary Core

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006729
• Other study ID #: H-42363
• Secondary ID: U01HL146382HSC20
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Vasan Ramachandran, MD
• Phone: (210) 450 7355
• Email: vasan[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The Risk Underlying Rural Areas Longitudinal (RURAL) Cohort is a health research project that plans to enroll approximately 4,600 adults in ten rural counties throughout Alabama (AL), Kentucky (KY), Louisiana (LA), and Mississippi (MS). The ten specific counties are: Dallas County, AL; Wilcox County, AL; Boyle County, KY; Perry County, KY; Garrard County, KY; Breathitt County, KY; Assumption Parish, LA; Franklin Parish, LA; Oktibbeha County, MS; and Panola County, MS. The study will help to better understand health and disease in these rural areas. The information gathered in this study will help build future health programs to improve the health of local people in your community, which may promote healthier lives. Several different aspects of the participants' health will be examined including heart and lung function.

Broad goals of the RURAL Cohort Study include:

• Identifying the frequency of and risk factors for heart and lung diseases in the RURAL communities

• Identifying unique factors contributing to health disorders in these communities - including psychosocial, economic, and familial factors - and how they interact together

• Identifying potential solutions by examining differences between higher and lower risk rural counties

Findings from the RURAL study will inform health care providers, participants, researchers and the community regarding the frequency, burden, determinants, and prognosis of heart, lung, blood, and sleep diseases in the rural South, provide new knowledge that is critical for rural implementation science, and set the stage for collaborative opportunities for a wider community of scientists.

Participants in the RURAL Study will receive information on different areas of their health, including their heart and lungs.

Investigators will visit participants in their communities to complete a research exam about heart and lung health. Participants will attend an in-person exam at the RURAL study mobile exam vehicle. On the mobile exam unit participants will also receive a Fitbit [activity tracker] device and a RURAL cell phone app that will be used to collect information about their health and lifestyle.

Participants will receive results from their research exam, which they can also share with their doctor. The RURAL Study team will refer participants to a health center if there are immediate health concerns found during the research exam.

The RURAL Study follows all HIPAA rules and regulations, in addition to the NIH and institutional guidelines, for the protection of all research participants. No information from the study that could identify a participant will be publicly shared.

The RURAL study team will track participants' physical activity using the provided Fitbit device. The RURAL health team will also ask questions about overall health and lifestyle through the RURAL cell phone app. Participants will receive a kit to measure environmental and health factors in your home.

The visit in the mobile exam vehicle will take about 3 hours and will include:

• Vital signs including height and weight

• Blood draw

• Interviews and surveys asking about lifestyle and health history

• Tests related to heart, lung, and blood vessel health

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4600
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Currently incarcerated or institutionalized

• Currently in hospice care with a terminal illness and less than 6 month life expectancy

• Being actively treated for cancer

Related Conditions & MeSH terms

• Heart Diseases
• Pulmonary Disease
• Rural Health

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for lung disease in rural areas		5 years
Primary	Risk factors for heart disease in rural areas		5 years
Secondary	Pulmonary function		5 years
Secondary	Heart function		5 years

External Links

•   The RURAL (Risk Underlying Rural Areas Longitudinal) Cohort Study aims to address critical gaps in our knowledge of heart and lung disorders in rural counties in the southeastern US.