Rural HealthRURALNCT05006729
Risk Underlying Rural Areas Longitudinal Cohort Study (RURAL) Heart and Lung Study
An observational study of Rural Health and Pulmonary Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rural Health, Pulmonary Disease, Heart Diseases
- How many people
- 4,600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Currently incarcerated or institutionalized
- Currently in hospice care with a terminal illness and less than 6 month life expectancy
- Being actively treated for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RURAL Heart and Lung Study
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.
Read the detailed 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
- Conditions
- Rural Health, Pulmonary Disease, Heart Diseases
- Keywords
- Risk factors for heart disease, Risk factors for lung disease, Psychosocial factors, Familial factors, Economic factors, Mobile examination unit (MEU), Alabama, Kentucky, Louisiana, Mississippi
- Medical subject headings
- Lung Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for lung disease in rural areas
Measured: 5 years
Risk factors for heart disease in rural areas
Measured: 5 years
Secondary outcomes (2)
Pulmonary function
Measured: 5 years
Heart function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start15 Jan 2021
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rural HealthStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Vasan Ramachandran, The University of Texas Health Science Center at San Antonio
- Investigators
- Vasan Ramachandran, MD, Study director, The University of Texas Health Science Center at San AntonioSuzanne Judd, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006729
- Sponsor's protocol ID
- H-42363
- Other IDs
- U01HL146382, 5N98026D00018, HSC20230132H
- Acronym
- RURAL
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2021
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RURAL Heart and Lung Study
- ClinicalTrials.gov ID
- NCT05006729
- Acronym / sponsor ID
- RURAL / H-42363
- Conditions
- Rural Health, Pulmonary Disease, Heart Diseases
- Keywords
- Risk factors for heart disease, Risk factors for lung disease, Psychosocial factors, Familial factors, Economic factors, Mobile examination unit (MEU), Alabama, Kentucky
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,600 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Currently incarcerated or institutionalized
- Currently in hospice care with a terminal illness and less than 6 month life expectancy
- Being actively treated for cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors for lung disease in rural areas
Time frame: 5 years
Risk factors for heart disease in rural areas
Time frame: 5 years
2 secondary outcomes
Pulmonary function
Time frame: 5 years
Heart function
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasan Ramachandran, MD study director
The University of Texas Health Science Center at San Antonio
Suzanne Judd, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rural Health and Pulmonary Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for lung disease in rural areas (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.