Attachment 3: Statement of Work Revised 0001

Attachment 3 – Statement of Work

STATEMENT OF WORK

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

Background
The Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study was initially funded as a Cooperative Agreement (U01HL146382) with the first Notice of Award being issued on May 2, 2019. The RURAL grant application was funded in response to NHLBI PAR-18-577, “New Epidemiology Cohort Studies in Heart, Lung, Blood, and Sleep Diseases and Disorders”. PAR-18577 solicited grant applications directly from the investigator community to establish a new longitudinal cohort study using a competitive, peer-reviewed process. The RURAL grant application had two specific aims:
Aim 1. Characterize a broad range of exposures across multiple domains both at the individual and at the community-level in RURAL participants. We will assess cross-sectionally how these exposures conjointly influence biological function and the prevalence of Heart, Lung, Blood, and Sleep (HLBS) risk factors, subclinical and clinical disease, and how these associations may be modified by age, sex, race/ethnicity, and residence in high vs. low-risk Appalachia, and Mississippi Delta (AMD) counties.
Aim 2. Relate the exposures (at the individual and group-level) to the incidence of overt HLBS disease and mortality prospectively, and evaluate both potential mediation by the presence of subclinical disease and effect modification by age, sex, race/ethnicity, and residence in high vs. low-risk AMD counties. As an ancillary aim, compare the associations of various exposures with HLBS risk in RURAL counties with corresponding associations in existing urban cohorts in the South using harmonized data.
The initial recruitment goal of the RURAL Heart and Lung Study (https://theruralstudy.org) was to enroll a cohort of 4,600 participants, ages 25-64, in the rural Southeastern US to better understand the health of those living in rural, underserved communities. The design of RURAL utilizes a mobile exam unit (MEU) to enroll and examine participants in 6 high risk, and 4 low risk, rural Southeastern counties in Alabama, Mississippi, Louisiana, and Kentucky. Enrollment in MS (2 counties), LA (2 counties), and KY (4 counties), have an ecological paired design in that rural counties at high risk for cardiopulmonary outcomes are paired with counties at lower risk based on county level demographic profiles. In AL, both counties are at high risk as demographically similar lower risk