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

A Combined Lifestyle and Medication Intervention to Reduce CVD Risk

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Lifestyle and medication intervention

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Durham Family Practice
    • Eden, North Carolina, United States, 27288
      • Dayspring Family Medicine
    • Kannapolis, North Carolina, United States, 28081
      • Cabarrus Family Medicine Residency
    • Moncure, North Carolina, United States, 27559
      • Moncure Community Health Center
    • Yanceyville, North Carolina, United States, 27379
      • Caswell Family Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted 10-year CHD risk	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	4-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted 10-year CHD risk	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.	12 months
Use of and adherence to cardiovascular medicines	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.	4 and 12 months
Dietary Intake	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.	4 and 12 months
Physical activity	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.	4 and 12 months
Blood pressure	Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor	4 and 12 months
Total, HDL, and direct LDL cholesterol	Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.	4 and 12 months
Smoking status	Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).	4 and 12 months
Adverse events	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).	4 and 12 months
Acceptability of the Intervention	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.	4 and 12 months
Cost-effectiveness	We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.	4 and 12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Thomas C Keyserling, MD, MPH, UNC-Chapel Hill; Study Director: Stacey L Sheridan, MD, MPH, UNC-Chapel Hill

Publications and helpful links

General Publications

• Keyserling TC, Sheridan SL, Draeger LB, Finkelstein EA, Gizlice Z, Kruger E, Johnston LF, Sloane PD, Samuel-Hodge C, Evenson KR, Gross MD, Donahue KE, Pignone MP, Vu MB, Steinbacher EA, Weiner BJ, Bangdiwala SI, Ammerman AS. A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. JAMA Intern Med. 2014 Jul;174(7):1144-57. doi: 10.1001/jamainternmed.2014.1984.
• Sheridan SL, Draeger LB, Pignone MP, Sloane PD, Samuel-Hodge C, Finkelstein EA, Gizlice Z, Vu MB, Gitterman DP, Bangdiwala SI, Donahue KE, Evenson K, Ammerman AS, Keyserling TC. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study. Contemp Clin Trials. 2013 Nov;36(2):394-405. doi: 10.1016/j.cct.2013.07.013. Epub 2013 Aug 2. Erratum In: Contemp Clin Trials. 2014 Jul;38(2):420-3.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 19, 2010
• First Submitted That Met QC Criteria: November 19, 2010
• First Posted (Estimate): November 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Medication adherence; Tailored interventions; Diet interventions; Physical activity interventions
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases
• Other Study ID Numbers: 10-2028; 1U48DP002658 (U.S. NIH Grant/Contract)