A Patient-Spouse Intervention for Self-Managing High Cholesterol

• low-density lipoprotein cholesterol [ Time Frame: Baseline, 6-month follow-up, 11-month follow-up ] [ Designated as safety issue: No ]
  

• adherence to medication, diet, and physical activity, and patient-physician communication [ Time Frame: Baseline, 6-month follow-up, 11-month follow-up ] [ Designated as safety issue: No ]
  

Background: Background/Rationale: Coronary heart disease (CHD) is the leading cause of death in the United States, resulting in more than 500,000 heart attacks and another 500,00 deaths per year. More than 80% of veterans have > 2 risk factors for CHD, underscoring the need for intervention. One major modifiable risk factor for CHD is elevated low-density lipoprotein cholesterol (LDL-C). Despite the proven success of diet, exercise, and medication, LDL-C frequently is not at the optimum level, due in part to patient nonadherence. Therefore, interventions are needed to increase adherence, thereby lowering LDL-C.

Objectives: Objectives: We will examine the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. The primary hypothesis is that patients enrolled in a 10-month, telephone-based patient-spouse intervention will experience a clinically meaningful 10% reduction in LDL-C. The secondary hypothesis is that patients who receive the intervention will show a significant increase in adherence to medication, diet, and exercise.

Methods: Methods: A 3-year randomized controlled trial will compare a one-year, telephone-based patient-spouse intervention to usual care. Married patients with above-goal LDL-C and their spouses will be consented (N = 250 couples), complete a baseline assessment, and then be randomly assigned to the intervention or usual care arm. During months 1-5, a nurse will deliver 4 educational modules (medication, diet, exercise, and patient-physician communication) to intervention couples via telephone. Each patient and spouse will receive two phone calls per module; the patient phone call will always precede the spouse phone call. During the patient calls, patients will create goals and action plans for that module. During the spouse calls, spouses will be informed of patients' goals and be given strategies to help patients achieve their goals. At 6 months, LDL-C and adherence will be re-assessed. During months 7-10, the intervention will be re-delivered, with the creation of new goals and action plans. At 11 months, LDL-C and adherence will be re-assessed. The primary outcome will be LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes will be adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months. Descriptive statistics will be computed for all study variables within each study arm. Mixed effects models will be used to evaluate the intervention's effect on the primary and secondary outcomes. We will also examine the cost effectiveness per 1% reduction in LDL-C.

Findings: None to date.

Status: Enrollment began in Fall, 2007 and was completed in July of 2009.

Impact: Elevated LDL-C is a major risk factor for CHD, stroke, and peripheral vascular disease, all of which are common among veterans. The expected increase in prevalence of CHD over the next several decades will result in an increased burden for both veterans and the VA health care system. Despite the known risk of hypercholesterolemia, many veterans have suboptimal LDL-C levels. As the latest evidence and recommendations suggest that these goals should be even lower, interventions to assist patients to lower LDL-C increasingly will be needed. The VA considers the reduction of LDL-C an important goal, as indicated by the major effort of the Ischemic Heart Disease Quality Enhancement Research Initiatives (QUERI). This study is important because (1) it addresses a highly prevalent risk factor for CHD among veterans; (2) it proposes a potentially low-cost method for improving LDL-C levels, which in turn could reduce VA healthcare costs; (3) the intervention is practical and could be disseminated easily in the VA healthcare system if proven effective; and (4) this intervention provides a model for self-management of other chronic diseases, such as diabetes and hypertension.