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

Cardiovascular Disease Clinical Trial

Official title:

A Combined Lifestyle and Medication Intervention to Reduce CVD Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245686
• Other study ID #: 10-2028
• Secondary ID: 1U48DP002658
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: February 5, 2013
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Durham Family Practice	Durham	North Carolina
United States	Dayspring Family Medicine	Eden	North Carolina
United States	Cabarrus Family Medicine Residency	Kannapolis	North Carolina
United States	Moncure Community Health Center	Moncure	North Carolina
United States	Caswell Family Medical Clinic	Yanceyville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Blood pressure	Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor	4 and 12 months	No
Secondary	Total, HDL, and direct LDL cholesterol	Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.	4 and 12 months	No
Secondary	Smoking status	Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).	4 and 12 months	No
Secondary	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	Yes
Secondary	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	No
Secondary	Cost-effectiveness	We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.	4 and 12 months	No