A Patient-Spouse Intervention for Self-Managing High Cholesterol

Hypercholesterolemia Clinical Trial

— CouPLES  

Official title:

A Patient-Spouse Intervention for Self-Managing High Cholesterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321789
• Other study ID #: IIR 05-273
• Status: Completed
• Phase: N/A
• First received: May 3, 2006
• Last updated: April 6, 2015
• Start date: September 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 interventio — View Citation

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) — View Citation

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. — View Citation

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-densit — View Citation

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: 10.1186/174 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density Lipoprotein Cholesterol	assessed with non-fasting blood test	11-month follow-up	No
Secondary	Caloric Intake	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Saturated Fat (Grams/Day)	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Total Fat (Grams/Day)	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Cholesterol Intake	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Fiber Intake	Self-reported, assessed via Block Brief Food Frequency Questionnaire.	11-month follow-up	No
Secondary	Frequency of Moderate Intensity Physical Activity	Self-reported via Community Health Activities Model Program for Seniors questionnaire.	11-month follow-up	No
Secondary	Duration of Moderate Intensity Physical Activity	Self-reported via Community Health Activities Model Program for Seniors questionnaire.	11-month follow-up	No
Secondary	Total Fat (%)	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Saturated Fat (%)	Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).	11-month follow-up	No
Secondary	Number of Participants With Goal LDL-C	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	No
Secondary	Number of Participants Prescribed Cholesterol Medication	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	No