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

NCT01245686 | Completed DMC

• 2 other identifiers: 10-20281U48DP002658
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cardiovascular Disease; Coronary Heart Disease

Keywords

Diet interventions; Physical activity interventions; Medication adherence; Tailored interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Predicted 10-year CHD risk

  12 months

• Use of and adherence to cardiovascular medicines

  4 and 12 months

• Dietary Intake

  4 and 12 months

• Physical activity

  4 and 12 months

• Blood pressure

  4 and 12 months

Study Arms (2)

One-on-one counseling

ACTIVE COMPARATOR

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

Web counseling

ACTIVE COMPARATOR

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

Interventions

Lifestyle and medication intervention BEHAVIORAL

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.

One-on-one counseling; Web counseling

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (5)

Durham Family Practice

Durham, North Carolina, 27704, United States

Location

Dayspring Family Medicine

Eden, North Carolina, 27288, United States

Location

Cabarrus Family Medicine Residency

Kannapolis, North Carolina, 28081, United States

Location

Moncure Community Health Center

Moncure, North Carolina, 27559, United States

Location

Caswell Family Medical Clinic

Yanceyville, North Carolina, 27379, United States

Location

Related Publications (2)

• 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.

  PMID: 24861959 DERIVED

• 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.

  PMID: 23916919 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Thomas C Keyserling, MD, MPH

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Stacey L Sheridan, MD, MPH

  UNC-Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (5)