Improving Heart Health in Appalachia (HeartHealth)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Debra Moser, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01884246
First received: June 14, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Obesity
Hypertension
Hyperlipidemia
Depression
Behavioral: patient-centered, culturally appropriate, self-care CVD risk reduction
Other: Referral to primary care provider for CVD risk management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Health Disparities in Appalachians With Multiple Cardiovascular Disease Risk Factors

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • cardiovascular risk factor selected by patient [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    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


  • cardiovascular risk factor selected by patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • all CVD risk factors of each patient [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    All CVD risk factors that each patient has are secondary outcomes

  • all CVD risk factors of each patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    All CVD risk factors that each patient has are secondary outcomes


Other Outcome Measures:
  • quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-care CVD risk reduction
A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
Behavioral: patient-centered, culturally appropriate, self-care CVD risk reduction Other: Referral to primary care provider for CVD risk management
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.
Other: Referral to primary care provider for CVD risk management

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884246

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40535
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Debra K Moser, DNSc, RN University of Kentucky
  More Information

No publications provided

Responsible Party: Debra Moser, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01884246     History of Changes
Other Study ID Numbers: PCORI 3048110484
Study First Received: June 14, 2013
Last Updated: June 19, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Kentucky:
lifestyle change
behavior change
obesity
hypertension
hyperlipidemia
physical inactivity
depression

Additional relevant MeSH terms:
Hyperlipidemias
Cardiovascular Diseases
Depression
Depressive Disorder
Hypertension
Obesity
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014