Improving Heart Health in Appalachia (HeartHealth)

March 7, 2017 updated by: Debra Moser

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40535
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Self-care CVD risk reduction
A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
Other Names:
  • HeartHealth
The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.
ACTIVE_COMPARATOR: Referral to primary care provider
The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.
The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

4 months
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

12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all CVD risk factors of each patient
Time Frame: 4 months
All CVD risk factors that each patient has are secondary outcomes
4 months
all CVD risk factors of each patient
Time Frame: 12 months
All CVD risk factors that each patient has are secondary outcomes
12 months

Other Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 4 months
4 months
quality of life
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Debra K Moser, DNSc, RN, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (ESTIMATE)

June 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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