Rural communities can be defined as “all territory, population, and housing units located outside of urbanized areas and urban clusters. Urbanized areas include populations of at least 50,000, and urban clusters include populations between 2,500 and 50,000.” (http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf   Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007 (Issue Brief #2)). Using this definition, the most recent data indicate about 70 million rural residents in the United States. Rural communities are characterized by a high prevalence of and varying disparities in heart disease morbidity and mortality (Brown and O'Connor, http://www.nejm.org/doi/full/10.1056/NEJMp1003880), including obesity, Chronic Obstructive Pulmonary Disease (COPD), hypertension and diabetes. As noted by Murray et al. (http://www.sciencedirect.com/science/article/pii/S0749379705002898), "startling life expectancy gaps as high as 15 years are evident, and “tens of millions of Americans are experiencing levels of health that are more typical of middle-income or low-income developing countries.” Clearly, the burden of cardiovascular disease risk factors, the wide life-expectancy gaps, and the unique challenges (and opportunities) in rural communities call for targeted research. The prevention and management of cardiovascular disease risk factors such as hypertension, obesity, diabetes, and adverse health behaviors (e.g., physical inactivity, poor dietary habits, sleep disorders, and smoking) in rural settings are often stymied by many challenges including:

1. Limited use of appropriate study designs or failure of investigators to evaluate the likelihood of success in rural settings of controlled trials that have had demonstrable efficacy in other settings.

2.  Interventions that are not sustained in rural communities and are characterized by brief, superficial encounters of investigators with rural communities, frequently resulting in research findings that are inadequately communicated and of little use to participants.

3.  Failure to consider the financial and transportation constraints, cultural barriers, and limited educational attainment of rural populations or to form partnerships with community agencies, to engage community members and health workers in their interventions or to test strategies to improve policies and infrastructure that have the potential to reduce cardiovascular disease risk.

4.  Limited number of studies that adapt evidence- or practice-based interventions to rural settings and address multiple cardiovascular disease risk factors even though such multiple risk factors co-exist and are more prevalent in rural populations. In addition, to successfully translate and sustain evidence- or practice-based interventions into practice in rural settings will require longer times and often more than five years. 

To overcome these challenges, applicants must address in their applications the following two stages:

1. Stage 1 is a planning phase to develop partnerships among a multi-disciplinary team of investigators (e.g., community agencies, academic institutions, social workers, policy makers, anthropologists and economists) and rural community health promoters, including community health workers to: (a) assess the community's resources and cardiovascular risk reduction needs, (b) engage the community through, for example, community-based participatory approaches, and (c) identify appropriate study design, target audience, recruitment and retention strategies, intervention approaches and evaluation methods. This initiative encourages collaboration among organizations, including collaboration among a network of community health centers or hospitals for optimal care of patients (e.g., hypertensive patients or patients with acute MI).

2.  Stage 2 is a developmental phase of small-scale, feasibility controlled clinical trials to explore approaches for adapting efficacious, evidence- or practice-based interventions into rural community settings. Investigators may identify ongoing practice-based interventions that are open to research and implement evidence-based interventions that have been found efficacious in non-rural settings. Investigators may also test new intervention approaches. Interventions must be based on sound study designs (e.g., RCTs) and analytic methods. Justification and threats to internal and external validity must be addressed if non-randomized study designs are used. Stage 1 activities will be expanded and integrated into the intervention.

Stage 1 planning phase (about 18 months) activities may include the following:

1. Identifying community stakeholders and partners, including those in public or regional health departments and health care organizations.  Applicants are encouraged to collaborate with local agencies (e.g., USDA Cooperative Extension Service or community-based agencies located in the rural county).

2. Forming leadership teams and coalitions to advise on development and implementation of the intervention.

3.  Obtaining cardiovascular disease risk factor burden assessment; review and analyze data.

4.  Identifying community engagement opportunities and how to best facilitate community development, training and partnerships. Applicants may use geographic information systems (geo-spatial mapping) and other novel approaches to identify their rural communities.

5. Applicants must specify their rural community and must select and justify their definitions (see definitions in this URL http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007, Issue Brief #2 http://www.hrsa.gov/advisorycommittees/rural/2008secreport.pdf).  

6.  Determine the best study design that will be used in the preliminary/feasibility study in Stage 2, and recruitment and retention strategies.

7.  Conduct formative research (e.g., focus groups, in-depth interviews, ethnography, photovoice) and determine the scope of the intervention and the specific risk reduction applicable to the study population (e.g., behavioral, environmental, and/or policy focused).  

Stage 2 feasibility phase (about 18 months) activities may include:

1. Testing on a small scale the hypothesis that adults who participate in multi-component interventions in multiple settings compared to a single component intervention (e.g., economic development intervention) will prevent or reduce multiple cardiovascular disease risk factors.

2.  Exploring the utility of various technologies for cardiovascular disease prevention in rural communities (e.g., telemedicine, electronic health records).

3.  Piloting research strategies to improve policies and community infrastructure shown in epidemiologic studies to have the potential to reduce cardiovascular disease risk factors.

4.  Exploring innovative approaches for adapting efficacious studies into practice in rural communities.

Applicants must delineate performance milestones in both Stages 1 and 2 that would assure the likelihood and feasibility of a successful larger-scale trial. Applicants must provide study timelines to be completed in Stages 1 and 2, rationale for the clinical trial to be developed in Stage 3, potential sustainability plans, and evidence that the intervention to be tested in Stage 3 is based on sound research findings in Stage 2. Applicants will be evaluated at the end of Stage 2 by an External Advisory Group to assess whether identified performance milestones have been met.

Successful Stage 1 and 2 awardees as well as others who can show promise of completing required activities and milestones in Stages 1 and 2 or have demonstrated feasibility in adapting efficacious interventions in rural settings would be eligible to apply for Stage 3 (Issuance of Stage 3 FOA to be determined at a later date). A major goal is to build the evidence base for interventions in rural communities; to implement and translate research findings into community and public health practice; and to accelerate the diffusion, adoption, integration, and sustainability of tested intervention. Applicants must design their studies to be sustainable and cost-effective.

In June 2010, NHLBI convened a workshop, in collaboration with other federal agencies to identify research gaps and to provide recommendations for future research in the development, implementation and evaluation of community interventions to reduce cardiovascular disease risk factors in rural communities. Recommendations from the workshop are available at http://www.nhlbi.nih.gov/meetings/workshops/cvd_rural_workshop/report.htm

Applicants are encouraged to be familiar with CDC's Million Hearts Initiative http://millionhearts.hhs.gov/ and to incorporate the Million Hearts strategies in their interventions to reduce the prevalence of CVD risk factors.  

The National Heart, Lung, and Blood Institute and other NIH Institutes have supported studies that have demonstrable efficacy or effectiveness in the prevention of cardiovascular risk factors including hypertension (e.g., Dietary Approaches to Stop Hypertension [DASH], and DASH sodium, DASH for Kids), obesity (POUNDS Lost, PREMIER), physical activity (e.g., Trial of Activity for Adolescent Girls, Activity Counseling Trial), diabetes (e.g., Diabetes Prevention Program, Look Ahead), all of which can be implemented and tested in rural community settings.

For coordination among investigators, applicants are required to participate in biannual meetings to enable sharing and collaborative problems solving. Applicants should budget for key investigators to attend two-day biannual face-to-face meetings in the Bethesda/Washington, D.C. Metro area. NHLBI, CDC and other staff will participate in the biannual meetings to provide technical and scientific assistance.

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