A Patient-Spouse Intervention for Self-Managing High Cholesterol (CouPLES)
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|ClinicalTrials.gov Identifier: NCT00321789|
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : September 26, 2014
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Behavioral: spouse-assisted intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Patient-Spouse Intervention for Self-Managing High Cholesterol|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2010|
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.
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.
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.
- Low-density Lipoprotein Cholesterol [ Time Frame: 11-month follow-up ]assessed with non-fasting blood test
- Caloric Intake [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Saturated Fat (Grams/Day) [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Total Fat (Grams/Day) [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Cholesterol Intake [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Fiber Intake [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire.
- Frequency of Moderate Intensity Physical Activity [ Time Frame: 11-month follow-up ]Self-reported via Community Health Activities Model Program for Seniors questionnaire.
- Duration of Moderate Intensity Physical Activity [ Time Frame: 11-month follow-up ]Self-reported via Community Health Activities Model Program for Seniors questionnaire.
- Total Fat (%) [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Saturated Fat (%) [ Time Frame: 11-month follow-up ]Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
- Number of Participants With Goal LDL-C [ Time Frame: 11-month follow-up ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321789
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Corrine I. Voils, PhD||Durham VA Medical Center, Durham, NC|