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

  • STATUS
    Recruiting
  • End date
    Mar 21, 2025
  • participants needed
    4600
  • sponsor
    Boston University
Updated on 22 August 2021

Summary

The Boston University Medical Campus (BUMC) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD, and the Pulmonary Core, led by George O'Connor, 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.

The RURAL pulmonary core's primary function will be to read the daily Pulmonary Function Tests (PFTs) performed by participants at each of RURAL's recruiting sites (Alabama, Kentucky, Louisiana, Mississippi). The BUMC Pulmonary Core investigators will receive de-identified data on a daily basis sent by the Statistical Data Coordinating Center at the University of Pennsylvania and will provide a clinical interpretation for each test and "score" the results for quality assurance purposes. Although the Pulmonary Core investigators will not have direct interaction with any participants, in rare circumstances, there may be a need to review identifiable results in the case of a medical emergency at one of the recruiting sites. The pulmonary core will also provide training for all staff who will carry out PFTs.

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. To get started, investigators will first speak with participants over the phone or by computer for a baseline visit. After this visit, participants will 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 then attend an in-person exam at the RURAL study mobile exam vehicle.

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.

During the baseline visit, participants will answer surveys about their medical history, lifestyle, and other health-related factors. The baseline visit will take about 35 to 50 minutes.

After the baseline visit, 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

Details
Condition Lung Disease, lung diseases, Cardiac Disease, rural health, Heart Disease, cardiac disorder, heart disorder, Heart disease, heart diseases, Cardiovascular Disease, cardiac diseases, cardiac disorders, pulmonary disorders, pulmonary diseases, Pulmonary Disease
Clinical Study IdentifierNCT05006729
SponsorBoston University
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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