DOI: 10.3886/icpsr36985.v1
title: Reduction of Health Disparities in Appalachians with Multiple Cardiovascular Disease Risk Factors: A Randomized Controlled Trial, 2013-2016
title: Version 1

description: This study consists of a two-group, randomized, controlled comparative effectiveness trial with 300 individuals from Appalachian Kentucky who do not have a primary care provider (and thus are not able to receive the standard of care without intercession) and who are at risk for CVD (cardiovascular disease) by virtue of having two or more modifiable CVD risk factors. The researchers compared (1) the standard of care alone, referral to a primary care provider for management of CVD risk factors, with (2) standard of care supplemented by patient-centered, culturally appropriate, self-care CVD risk reduction intervention (HeartHealth) designed to improve multiple CVD risk factors while overcoming barriers to success. The researchers compared the 4 month (short-term) and 1 year (long-term) impact of the interventions on: 1) CVD risk factors selected by patients (i.e., tobacco use, blood pressure, lipid profile, HgA1c for diabetics, body mass index, waist circumference, depressive symptoms, or physical activity level); 2) all CVD risk factors for each patient; 3) quality of life; 4) patient and healthcare provider satisfaction; 5) desirability and adoptability by assessing adherence to recommended CVD risk reduction protocols, and retention of recruited individuals. Demographic variables include gender, age, ethnicity, marital status, employment status, and level of education.
description: The central hypothesis of the study is that to be successful in distressed environments CVD risk reducing interventions must focus on patient-centered lifestyle change that increases individuals' abilities to engage in self-care, be culturally appropriate, and have components that overcome barriers in such environments.
description: A two-group randomized, controlled comparative effectiveness trial (Figure 2) was used to compare the effect of: the standard of care alone, which is referral to a healthcare provider for management of CVD risk factors with referral to a healthcare provider for CVD risk factor management plus a patient-centered, culturally appropriate, self-care CVD risk reduction intervention designed to improve multiple CVD risk factors while overcoming barriers to success (the HeartHealth intervention). The study enrolled individuals who, at the time of recruitment, did not have a primary care provider and who were at risk for CVD. The sample of 300 was randomly assigned to one of the two groups once the informed consent process was completed.
description: None.
description: Presence of Common Scales: Montreal Cognitive Assessment (MoCA) Patient Health Questionnaire-9 (PHQ-9) SF-12v2 (a shorter version of the Medical Outcomes Trust Short Form SF36 Health Survey versions 2.0 (SF-36v2)) Patient Satisfaction Questionnaire-III Healthcare Provider Satisfaction Questionnaire Medical Outcomes Study Specific Adherence Scale Charlson Comorbidity Index
description: The study was offered to residents of eastern Appalachian KY. Individuals were included if they do not have a primary care provider. All individuals of either gender, any ethnicity, and any age 21 or older and who are at risk for CVD as reflected by having two or more of the following modifiable risk factors were eligible: Clinical diagnosis of hypertension or taking medications for hypertension or found to be hypertensive by us based on JNCVII guidelines for hypertension Clinical diagnosis of hyperlipidemia or taking medication for treating abnormal lipid levels, or any lipid abnormality found on our screening that indicates hyperlipidemia based on Adult Treatment Panel III guidelines68; diagnosis of type 2 diabetes or HgA1c &gt; 7% found on our screening; overweight or obese (body mass index ≥ to 25 kg/m2); waist circumference &gt; 40 inches in men or &gt; 35 inches in women; clinical diagnosis of depression, on medications for depression or found to have depressive symptoms (score of &gt; 9 on the PHQ-9) by our baseline screening; sedentary lifestyle meaning that the individual does not engage in at least 30 minutes of moderate activity (e.g., sustained gardening or yard care; brisk housework such a vacuuming, mopping floors; brisk walking; swimming; bicycling; physically demanding activity that produces sustained aerobic exercise) for at least 4 days per week. Individuals will be excluded if they have known coronary artery disease, cerebrovascular disease, history of acute coronary syndrome or peripheral arterial disease. Although CVD risk reduction is vitally important in this population, the presence of existing CVD, in which CVD risk factors are treated more aggressively with medications, may introduce a confounding influence. Individuals will also be excluded for any of the following: taking medications (e.g., protease inhibitors) that interfere with lipid metabolism; cognitive impairment that precludes an individual from understanding the consent process, answering questionnaires, or participating in the intervention (cognitive impairment will be assessed using the Mini-Cog); chronic drug abuse; end-stage renal or liver or pulmonary disease; current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer treatable by simple excision; gastrointestinal disease that requires special diets (e.g., Crohn's disease; celiac disease).
description: Datasets: DS1: Reduction of Health Disparities in Appalachians with Multiple Cardiovascular Disease Risk Factors: A Randomized Controlled Trial, 2013-2016
description: Residents of eastern Appalachian Kentucky aged 21 and older and without a primary care provider who are at risk for cardiovascular disease.
description: computer-assisted personal interview (CAPI); on-site questionnaireData collected from the Jawbone UP activity tracker is not available as part of this release.Additional information about the Reduction of Health Disparities in Appalachians with Multiple Cardiovascular Disease risk Factors: A Randomized Controlled Trial, 2013-2016 study can be found on the PCORI project website.Medical Subject Heading (MeSH) terms that apply to this study include: Behavioral Medicine, Cardiovascular Diseases, Comorbidity, Depression, Health Services Accessibility, Hypertension, Metabolic Diseases, Obesity, Patient Care, Stroke, Tobacco Use Cessation.