A Patient-Spouse Intervention for Self-Managing High Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00321789
First received: May 3, 2006
Last updated: February 6, 2014
Last verified: October 2010
  Purpose

We will examine the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A 3-year randomized controlled trial will compare a one-year, telephone-based patient-spouse intervention to usual care. 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.


Condition Intervention
Hypercholesterolemia
Behavioral: patient-spouse self-management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Patient-Spouse Intervention for Self-Managing High Cholesterol

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 255
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Couples enrolled in the experimental arm will receive nine monthly phone calls from a nurse. 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 patient in achieving the goals.
Behavioral: patient-spouse self-management
Couples enrolled in the experimental arm will receive nine monthly phone calls from a nurse. 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 patient in achieving the goals.
No Intervention: Arm 2
Couples assigned to this group will not receive the monthly phone calls.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • veteran;
  • above-goal low-density lipoprotein cholesterol level;
  • married

Exclusion Criteria:

  • no telephone number;
  • spouse unwilling to participate;
  • patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent;
  • hospitalized past 3 months;
  • survival prognosis less than 1 year;
  • active psychosis or dementia; no primary care physician at VA;
  • no medical visit to VA in past year;
  • enrolled in another study focusing on lifestyle changes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321789

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Corrine I. Voils, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00321789     History of Changes
Other Study ID Numbers: IIR 05-273
Study First Received: May 3, 2006
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
self care
social support

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 09, 2014