Improving Heart Health in Appalachia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, High Blood Pressure (Hypertension), High Cholesterol, Obesity Weight Loss, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | December 2016 |
Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors
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.
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.
Inclusion Criteria:
- residents of eastern Appalachian Kentucky
- do not have a primary care provider
- at risk for CVD as reflected by having two or more of the following modifiable risk
factors
1. clinical diagnosis of hypertension or taking medications diagnosed for
hypertension or found to be hypertensive on screening;
2. clinical diagnosis of hyperlipidemia or taking medication for treating abnormal
lipid levels, or any lipid abnormality found on screening that indicates
hyperlipidemia;
3. diagnosis of type 2 diabetes or HgA1c > 7% found on screening;
4. overweight or obese (body mass index ≥ 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 Patient Health Questionnaire-9) by
baseline screening;
7. sedentary lifestyle meaning that the individual does not engage in at least 30
minutes of moderate activity for at least 4 days per week
Exclusion Criteria:
- known coronary artery disease, cerebrovascular disease, history of acute coronary
syndrome or peripheral arterial disease;
- 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;
- 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)
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