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OpenTrials
Completed

NCT Number: NCT01884246

Improving Heart Health in Appalachia

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • clinical diagnosis of hypertension or taking medications diagnosed for hypertension or found to be hypertensive on screening;
  • clinical diagnosis of hyperlipidemia or taking medication for treating abnormal lipid levels, or any lipid abnormality found on screening that indicates hyperlipidemia;
  • diagnosis of type 2 diabetes or HgA1c > 7% found on screening;
  • overweight or obese (body mass index ≥ 25 kg/m2);
  • waist circumference > 40 inches in men or > 35 inches in women;
  • 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;
  • 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)

Treatment and study plan

Self-care CVD risk reduction

Behavioral

A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.

Other names: HeartHealth

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.

Primary outcomes

  1. cardiovascular risk factor selected by patient

    Time frame: 4 months

    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

  2. cardiovascular risk factor selected by patient

    Time frame: 12 months

    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

Secondary outcomes

  1. all CVD risk factors of each patient

    Time frame: 4 months

    All CVD risk factors that each patient has are secondary outcomes

  2. all CVD risk factors of each patient

    Time frame: 12 months

    All CVD risk factors that each patient has are secondary outcomes

Other outcomes

  1. quality of life

    Time frame: 4 months

  2. quality of life

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Debra Moser

Other

Collaborators

  • University of Kentucky Center for Excellence in Rural Health-Hazard

Registry information

Official study title

Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors

Acronym: HeartHealth

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2013
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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