Reduction of Health Disparities in Appalachians with Multiple Cardiovascular Disease Risk Factors: A Randomized Controlled Trial, 2013-2016 (ICPSR 36985)

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Study Purpose View help for Study Purpose

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.

Study Design View help for Study Design

A two-group randomized, controlled comparative effectiveness trial (Figure 2) was used to compare the effect of:

1. the standard of care alone, which is referral to a healthcare provider for management of CVD risk factors with
2. 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.

Sample View help for Sample

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:

1. Clinical diagnosis of hypertension or taking medications for hypertension or found to be hypertensive by us based on JNCVII guidelines for hypertension
2. 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;
3. diagnosis of type 2 diabetes or HgA1c > 7% found on our screening;
4. overweight or obese (body mass index ≥ to 25 kg/m2);
5. waist circumference > 40 inches in men or > 35 inches in women;
6. clinical diagnosis of depression, on medications for depression or found to have depressive symptoms (score of > 9 on the PHQ-9) by our baseline screening;
7. 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:

1. taking medications (e.g., protease inhibitors) that interfere with lipid metabolism;
2. 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);
3. chronic drug abuse;
4. end-stage renal or liver or pulmonary disease;
5. current active cancer (i.e., undergoing active treatment for cancer) other than isolated skin cancer treatable by simple excision;
6. gastrointestinal disease that requires special diets (e.g., Crohn's disease; celiac disease).

Time Method View help for Time Method

Universe View help for Universe

Residents of eastern Appalachian Kentucky aged 21 and older and without a primary care provider who are at risk for cardiovascular disease.

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Mode of Data Collection View help for Mode of Data Collection

Presence of Common Scales View help for 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

Original Release Date View help for Original Release Date

2018-02-09

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Weight View help for Weight

None.