- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00321789
A Patient-Spouse Intervention for Self-Managing High Cholesterol (CouPLES)
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-density Lipoprotein Cholesterol
Time Frame: 11-month follow-up
|
assessed with non-fasting blood test
|
11-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caloric Intake
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Saturated Fat (Grams/Day)
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Total Fat (Grams/Day)
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Cholesterol Intake
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Fiber Intake
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire.
|
11-month follow-up
|
Frequency of Moderate Intensity Physical Activity
Time Frame: 11-month follow-up
|
Self-reported via Community Health Activities Model Program for Seniors questionnaire.
|
11-month follow-up
|
Duration of Moderate Intensity Physical Activity
Time Frame: 11-month follow-up
|
Self-reported via Community Health Activities Model Program for Seniors questionnaire.
|
11-month follow-up
|
Total Fat (%)
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
Saturated Fat (%)
Time Frame: 11-month follow-up
|
Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).
|
11-month follow-up
|
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).
|
11-month follow-up
|
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).
|
11-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Corrine I. Voils, PhD, Durham VA Medical Center, Durham, NC
Publications and helpful links
General Publications
- Voils CI, Yancy WS Jr, Weinberger M, Bolton J, Coffman CJ, Jeffreys A, Oddone EZ, Bosworth HB. The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model. Patient Educ Couns. 2011 Jul;84(1):33-40. doi: 10.1016/j.pec.2010.06.005. Epub 2010 Jul 5.
- Voils CI, Yancy WS Jr, Kovac S, Coffman CJ, Weinberger M, Oddone EZ, Jeffreys A, Datta S, Bosworth HB. Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial. Trials. 2009 Feb 6;10:10. doi: 10.1186/1745-6215-10-10.
- Voils CI, Coffman CJ, Yancy WS Jr, Weinberger M, Jeffreys AS, Datta S, Kovac S, McKenzie J, Smith R, Bosworth HB. A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol. Prev Med. 2013 Jan;56(1):46-52. doi: 10.1016/j.ypmed.2012.11.001. Epub 2012 Nov 9.
- Gallagher P, Yancy WS Jr, Jeffreys AS, Coffman CJ, Weinberger M, Bosworth HB, Voils CI. Patient self-efficacy and spouse perception of spousal support are associated with lower patient weight: baseline results from a spousal support behavioral intervention. Psychol Health Med. 2013;18(2):175-81. doi: 10.1080/13548506.2012.715176. Epub 2012 Sep 10.
- King HA, Jeffreys AS, McVay MA, Coffman CJ, Voils CI. Spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle change intervention to improve patient low-density lipoprotein cholesterol. J Behav Med. 2014 Dec;37(6):1102-7. doi: 10.1007/s10865-014-9559-4. Epub 2014 Mar 2.
- Sperber NR, Sandelowski M, Voils CI. Spousal support in a behavior change intervention for cholesterol management. Patient Educ Couns. 2013 Jul;92(1):121-6. doi: 10.1016/j.pec.2013.02.015. Epub 2013 Mar 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 05-273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypercholesterolemia
-
National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
-
Direct PlantesUnknownHYPERCHOLESTEROLEMIAFrance
-
Chong Kun Dang PharmaceuticalRecruitingPrimary HypercholesterolemiaKorea, Republic of
-
Addpharma Inc.CompletedPrimary HypercholesterolemiaKorea, Republic of
-
JW PharmaceuticalCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Provident Clinical ResearchGlaxoSmithKlineUnknownPrimary HypercholesterolemiaUnited States
-
Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
-
Merck Sharp & Dohme LLCTerminated
-
Danone JapanCompletedHealthy | Mild HypercholesterolemiaJapan
Clinical Trials on spouse-assisted intervention
-
University of MichiganWayne State UniversityCompletedQuality of Life | Prostate Cancer | Cancer SurvivorshipUnited States
-
Centre For International HealthMakerere UniversityCompleted
-
University of AlbertaCanadian Breast Cancer FoundationCompleted
-
Corindus Inc.CompletedMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive DiseasesUnited States, Israel
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain
-
Daniel Collado-MateoPurina España (Reg. Trademark of Nestle S.A.)Enrolling by invitationEating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/BulimiaSpain
-
Daniel Collado-MateoAsociación de Padres de Personas Con Autismo (APNA); Asociación Nuevo Horizonte and other collaboratorsEnrolling by invitationAutism Spectrum Disorder | AutismSpain
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research...Completed
-
University of RochesterNational Cancer Institute (NCI); National Library of Medicine (NLM)Completed
-
Atlas UniversityNot yet recruitingDepression | Loneliness | Old Age; Debility | Nursing Home | Loss of Interest in Activities