NCT01884246

Improving Heart Health in Appalachia

Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Debra Moser · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Individuals in Appalachian Kentucky are vulnerable to cardiovascular disease (CVD) by virtue of having high rates of multiple CVD risk factors. There is a critical need to develop and test CVD risk reducing interventions that are appropriate and effective in Appalachia. In the absence of such interventions, the dramatic CVD disparities seen in this area will continue to rise. Lifestyle interventions reduce CVD risk by 44%. The investigators and others have demonstrated that lifestyle change is most effective when patients are given the tools to engage in effective self-care, and that interventions individualized to patients' specific needs and barriers are more effective than interventions that are not. The central hypothesis is that to be successful in Appalachia, CVD risk reducing interventions must focus on patient-centered lifestyle change that increase individuals' abilities to engage in self-care, must be culturally appropriate, and must have components that overcome barriers faced by individuals living in Appalachia. The investigators propose a randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider and who are at risk for CVD by virtue of having two or more modifiable CVD risk factors. The investigators will compare (1) a patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success with (2) referral of patients to a primary care provider for management of their CVD risk factors. The investigators propose the following specific aims to be tested at 4 months and 1 year after baseline. To compare the short and long-term impact of the interventions on: 1\) the risk factor selected by patients (i.e., tobacco use, blood pressure, lipid profile, hemoglobin-A1c (HgA1c) for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all of the CVD risk factors of each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction measures, and retention of recruited individuals. The investigators hypothesize that in comparison to the referral strategy, the multifaceted patient-centered, self-care intervention will engender more favorable outcomes across all measures.

Conditions

• Obesity
• Hypertension
• Hyperlipidemia
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Self-care CVD risk reduction	A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
OTHER	Referral to primary care provider for CVD risk management	The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2013-06-21
• Last updated: 2017-03-10

Locations

1 site across 1 country: United States