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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Disease Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lifestyle and medication intervention

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Lifestyle and medication intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes