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| Name | Class |
|---|---|
| University of Kentucky Center for Excellence in Rural Health-Hazard | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-care CVD risk reduction | Experimental | A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients. |
|
| Referral to primary care provider | Active Comparator | The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-care CVD risk reduction | Behavioral | A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular risk factor selected by patient | Patient selects their own risk reduction goal from the following: smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference | 4 months |
| cardiovascular risk factor selected by patient | Patient selects their own risk reduction goal from the following: smoking, blood pressure, lipid profile, body mass index, hemoglobin-A1c for diabetics, depression, physical activity level, waist circumference | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| all CVD risk factors of each patient | All CVD risk factors that each patient has are secondary outcomes | 4 months |
| all CVD risk factors of each patient | All CVD risk factors that each patient has are secondary outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | 4 months | |
| quality of life | 12 months |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra K Moser, DNSc, RN | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40535 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D003863 | Depression |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Referral to primary care provider for CVD risk management | Other | The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider. |
|
| 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |