Clinical trial NCT01245686: Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
Official title: A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Coronary Heart Disease
Keywords: Diet interventions
Physical activity interventions
Medication adherence
Tailored interventions
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-11-22
Enrollment: 489
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Predicted 10-year CHD risk
timeFrame: 4-month follow-up
Secondary outcomes:
measure: Predicted 10-year CHD risk
timeFrame: 12 months
measure: Use of and adherence to cardiovascular medicines
timeFrame: 4 and 12 months
measure: Dietary Intake
timeFrame: 4 and 12 months
measure: Physical activity
timeFrame: 4 and 12 months
measure: Blood pressure
timeFrame: 4 and 12 months
measure: Total, HDL, and direct LDL cholesterol
timeFrame: 4 and 12 months
measure: Smoking status
timeFrame: 4 and 12 months
measure: Adverse events
timeFrame: 4 and 12 months
measure: Acceptability of the Intervention
timeFrame: 4 and 12 months
measure: Cost-effectiveness
timeFrame: 4 and 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Family Practice
state: North Carolina
city: Eden
country: United States
facility: Dayspring Family Medicine
state: North Carolina
city: Kannapolis
country: United States
facility: Cabarrus Family Medicine Residency
state: North Carolina
city: Moncure
country: United States
facility: Moncure Community Health Center
state: North Carolina
city: Yanceyville
country: United States
facility: Caswell Family Medical Clinic
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Thomas C Keyserling, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC-Chapel Hill
name: Stacey L Sheridan, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.