Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Keyserling, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01245686
First received: November 19, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.

Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).

The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.

Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.


Condition Intervention
Cardiovascular Disease
Coronary Heart Disease
Behavioral: Lifestyle and medication intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Predicted 10-year CHD risk [ Time Frame: 4-month follow-up ] [ Designated as safety issue: No ]

    Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period.

    We will examine absolute changes in this outcome in both intervention arms. We will also examine whether this outcome varies by subgroups of the following variables: baseline level of predicted CHD risk, age, race, SES, insurance status, overall health status, numeracy, literacy, # medications, # of perceived barriers to adherence, use of the intervention, time with the intervention, study practice site, and health counselor



Secondary Outcome Measures:
  • Predicted 10-year CHD risk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period.

  • Use of and adherence to cardiovascular medicines [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]

    Use of cardiovascular medicines will be by self-report. Adherence to cardiovascular medicines will be measured by the 8-Item Morisky scale and a single-item specifying overall percentage adherence to cardiovascular medicines(categorical).

    Participants will additionally report use of and adherence to individual medicines, including aspirin, blood pressure medicine, and cholesterol medicine. Aspirin adherence will be validated by serum thromboxane b2 in a subsample of participants. Blood pressure and cholesterol medicine use will be confirmed by changes in blood pressure and cholesterol.


  • Dietary Intake [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Dietary intake will be measured through a combination of self-report and objective measures. Participants will self-report diet on two validated questionnaires: the block questionnaire (fruit and vegetable intake) and the fat quality screener. Fruit and vegetable intake will be objectively measured by serum carotenoids. Fat quality will be objectively measured using RBC membrane fatty acids.

  • Physical activity [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Physical activity will be measured through a combination of self-report and objective measures. Participants will report physical activity on the validated modified RESIDE questionnaire. They will additionally wear a pedometer to monitor their daily total and aerobic steps.

  • Blood pressure [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor

  • Total, HDL, and direct LDL cholesterol [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.

  • Smoking status [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).

  • Adverse events [ Time Frame: 4 and 12 months ] [ Designated as safety issue: Yes ]
    We will monitor the following adverse events: ED visits (self-report), hospitalizations (self-report), deaths (family report confirmed by death registry), GI bleeds (self-report), hemorrhagic stroke (self-report), musculoskeletal injury (self-report), renal dysfunction (serum creatinine), and liver dysfunction (AST).

  • Acceptability of the Intervention [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    We will measure the acceptability of the intervention using process measures querying participants, office staff, and clinicians about the perceptions of the acceptability of the intervention and the time to deliver it.

  • Cost-effectiveness [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
    We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.


Enrollment: 489
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One-on-one counseling
Participants in this arm will receive 4 intensive one-on-one counseling sessions (either in person or on the phone) and 3 brief maintenance sessions.
Behavioral: Lifestyle and medication intervention
The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence). The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
Active Comparator: Web counseling
Participants in this arm will receive 4 intensive counseling sessions over the web. They will also receive 3 maintenance sessions over the web.
Behavioral: Lifestyle and medication intervention
The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence). The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.

  Eligibility

Ages Eligible for Study:   35 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Established patients
  • Men ages 35-79
  • Women ages 45-79
  • History of CVD (100 participants)
  • CHD risk equal or greater than 10%
  • elevated CHD risk factor

Exclusion Criteria:

  • non-English speaking
  • no phone
  • treatment of psychosis
  • history of alcohol/substance abuse within last 2 years
  • pregnancy, breast feeding, or anticipated pregnancy in next 18 months
  • history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for >5 years
  • recent history (in past year) of hypoglycemic event requiring medical attention
  • estimated creatinine clearance less than 30 ml/min
  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: NCT01245686

Locations
United States, North Carolina
Durham Family Practice
Durham, North Carolina, United States, 27704
Dayspring Family Medicine
Eden, North Carolina, United States, 27288
Cabarrus Family Medicine Residency
Kannapolis, North Carolina, United States, 28081
Moncure Community Health Center
Moncure, North Carolina, United States, 27559
Caswell Family Medical Clinic
Yanceyville, North Carolina, United States, 27379
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Thomas C Keyserling, MD, MPH UNC-Chapel Hill
Study Director: Stacey L Sheridan, MD, MPH UNC-Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Keyserling, MD, MPH, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01245686     History of Changes
Other Study ID Numbers: 10-2028, 1U48DP002658
Study First Received: November 19, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Diet interventions
Physical activity interventions
Medication adherence
Tailored interventions

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014