The Department of Veterans Affairs is sponsoring a trial to determine the effectiveness of spousal intervention in reducing low-density lipoprotein cholesterol (LDL-C) by increasing patient treatment adherence. The 3-year randomized controlled trial will compare a 1-year, telephone-based patient-spouse intervention to usual care vs no intervention. The patient subject will choose monthly goals related to diet, exercise, patient-provider communication, or medication adherence. The spouse subject will be encouraged to support the subject (his or her spouse) in achieving these goals. Couples in the other, or “No Intervention” group, will not receive phone calls.

Study Rationale

Coronary heart disease (CHD) is the leading cause of death in the United States, and is responsible for more than 500,000 heart attacks and an additional 50,000 deaths per year. Closer to home, more than 80% of veterans have two-plus risk factors for CHD. One major risk factor that can be modified or eliminated is elevated LDL-C. However, due to patient non-adherence to proper diet, exercise, or prescribed medication, optimum LDL-C levels are frequently not achieved.

Risk Factors for CHD

What are the risk factors for CHD? The American Heart Association has identified several risk factors, some of which can be modified, treated or controlled, and some that cannot. The more risk factors an individual has, the greater the chance of developing coronary heart disease. Also, the greater the level of each risk factor, the greater the risk. For example, a person with a total cholesterol of 300 mg/dL has a greater risk than someone with a total cholesterol of 245 mg/dL, even though everyone with a total cholesterol greater than 240 is considered high-risk.

Risk factors that cannot be changed include:

• Age
• Gender
• Heredity

Risk factors that can be changed or eliminated include:

• Tobacco smoke
• High blood cholesterol
• High blood pressure
• Physical inactivity
• Obesity/excess weight
• Diabetes

What We Hope to Achieve

This study will endeavor to analyze the impact of a patient/spouse intervention aimed at lowering LDL-C by increasing patient adherence to treatment. The primary and secondary hypotheses of the study respectively are:

• Patients will experience a clinically meaningful 10% reduction in LDL-C.
• Patients will show a significant increase in adherence to medication, diet, and exercise.

How the Study Will Be Conducted

The study itself will be a three-year randomized control trial, telephone-based patient-spouse intervention to usual care. The target population goal is 250 couples who will be randomly assigned to the intervention or usual care arm. During the first fi ve months, a nurse will deliver four educational modules (medication, diet, exercise, and patient-physician communication) to the intervention couples. Each patient and spouse will receive two calls per module, and patients will create goals and action plans for that particular module. The respective spouses will be informed of the patients’ goals, and given strategies to help their patients achieve their goals.

Adherence will be reassessed at six months, and during the subsequent four months, the intervention will be re-delivered, along with the creation of new goals and action plans.

At 11 months, LDL-C and adherence will be re-assessed, with the primary outcome being LDL-C measured at baseline, 6 and 11 months. Secondary outcomes will be adherence to medication, diet, and exercise measured at the same benchmarks. Additionally, cost efficacy per 1% reduction in LDL-C will factor.

Current Status

To date, there are no findings to report. One hundred seventy couples are participating, and recruitment is ongoing.

The criteria for inclusion are:

• Veteran
• Above-goal low-density lipoprotein cholesterol level
• Married

Exclusion criteria are:

• No telephone number
• Spouse unwilling to participate
• Patient or spouse cognitively impaired, unable to communicate via telephone, living in a nursing home or receiving home health care, or refusal to provide informed consent
• Hospitalized in the past three months
• Survival prognosis less than one year
• Active psychosis or dementia
• No primary care physician at VA
• No medical visit to VA in past year
• Currently enrolled in another study focusing on lifestyle changes

The study is being conducted at the VA Medical Center in Durham, North Carolina, under the direction of principal investigator Corrine Voils, PhD. The sub-investigators are Hayden Bosworth, PhD and Stacey Kovac, PhD. The study is sponsored by the Department of Veteran Affairs, and can be referred to by its Clinical Trials.gov identifi er NCT00321789.