A Patient-Spouse Intervention for Self-Managing High Cholesterol (CouPLES)

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: September 25, 2014
Last verified: September 2014

May 3, 2006
September 25, 2014
September 2007
July 2010   (final data collection date for primary outcome measure)
Low-density Lipoprotein Cholesterol [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
assessed with non-fasting blood test
low-density lipoprotein cholesterol
Complete list of historical versions of study NCT00321789 on ClinicalTrials.gov Archive Site
  • Caloric Intake [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Saturated Fat (Grams/Day) [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Total Fat (Grams/Day) [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Cholesterol Intake [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Fiber Intake [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire.
  • Frequency of Moderate Intensity Physical Activity [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported via Community Health Activities Model Program for Seniors questionnaire.
  • Duration of Moderate Intensity Physical Activity [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported via Community Health Activities Model Program for Seniors questionnaire.
  • Total Fat (%) [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Saturated Fat (%) [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
  • Number of Participants With Goal LDL-C [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    Assessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).
  • Number of Participants Prescribed Cholesterol Medication [ Time Frame: 11-month follow-up ] [ Designated as safety issue: No ]
    This was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).
adherence to medication, diet, and physical activity, and patient-physician communication
Not Provided
Not Provided
 
A Patient-Spouse Intervention for Self-Managing High Cholesterol
A Patient-Spouse Intervention for Self-Managing High Cholesterol

We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months.

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 examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. The primary hypothesis was that patients enrolled in a telephone-based, spouse-assisted intervention will experience a clinically meaningful 7% reduction in LDL-C. The secondary hypotheses were that patients who receive the intervention would show a significant increase in adherence to medication, diet, and exercise.

Methods: In a 3-year study, a randomized controlled trial compared a 10-month, telephone-based, spouse-assisted intervention to usual care. Married patients with above-goal LDL-C and their spouses were consented, completed a baseline assessment, and then were randomly assigned to the intervention or usual care arm. Month 1 involved an educational call delivered to patients and spouses. Months 2-10 (except month 6) involved monthly goal setting calls delivered to patients and calls focused on increasing social support to spouses. The patient phone call will always preceded the spouse phone call. At 6 and 11 months, LDL-C and adherence were re-assessed. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months. Descriptive statistics were computed for all study variables within each study arm. Mixed effects models were used to evaluate the intervention's effect on the primary and secondary outcomes at 11 months. We also calculated intervention cost.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Hypercholesterolemia
Behavioral: spouse-assisted intervention
Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.
  • Experimental: Spouse-assisted intervention
    Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse developed a plan to support patient goal achievement.
    Intervention: Behavioral: spouse-assisted intervention
  • No Intervention: Usual care
    Couples assigned to this arm received educational materials at baseline and usual care thereafter, with no contact from the study interventionist.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
August 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • veteran
  • elevated baseline 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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00321789
IIR 05-273
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Corrine I. Voils, PhD Department of Veterans Affairs
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP