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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spouse-assisted intervention | Experimental | 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. |
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| Usual care | No Intervention | Couples assigned to this arm received educational materials at baseline and usual care thereafter, with no contact from the study interventionist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spouse-assisted intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density Lipoprotein Cholesterol | assessed with non-fasting blood test | 11-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Caloric Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | 11-month follow-up |
| Saturated Fat (Grams/Day) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrine I. Voils, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20599337 | Result | 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. | |
| 19200384 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal. |
| FG001 | Usual Care | Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Low-density Lipoprotein Cholesterol | assessed with non-fasting blood test | Posted | Mean | Standard Deviation | mg/dL | 11-month follow-up |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment |
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The dietary measure underestimates dietary intake but should not invalidate differences between groups or across time. Sample size for dietary analyses was reduced due to missing data, but non-responders did not differ on measured characteristics.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corrine I. Voils | Veterans Affairs Medical Center | 919-286-0411 | 5196 | corrine.voils@va.gov |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 11-month follow-up |
| Total Fat (Grams/Day) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | 11-month follow-up |
| Cholesterol Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | 11-month follow-up |
| Fiber Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire. | 11-month follow-up |
| Frequency of Moderate Intensity Physical Activity | Self-reported via Community Health Activities Model Program for Seniors questionnaire. | 11-month follow-up |
| Duration of Moderate Intensity Physical Activity | Self-reported via Community Health Activities Model Program for Seniors questionnaire. | 11-month follow-up |
| Total Fat (%) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | 11-month follow-up |
| Saturated Fat (%) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | 11-month follow-up |
| 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 |
| 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 |
| 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. |
| 23146744 | Result | 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. |
| 22963235 | Result | 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. |
| 24584818 | Result | 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. |
| 23541217 | Result | 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. |
| Protocol Violation |
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| BG001 | Usual Care | Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Number | participants |
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| Employment status | Number | participants |
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| High risk for cardiovascular event based on Framingham score | Number | participants |
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| number of participants who met goal for low-density lipoprotein cholesterol at baseline | 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 | participants |
|
| number of participants prescribed cholesterol medication at baseline | Number | participants |
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| Missed at least one dose of cholesterol medication in previous 30 days at baseline | Based on self-report to a single item querying whether participants missed doses in the previous 30 days. | Number | participants |
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| Secondary | Caloric Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | kcal/day | 11-month follow-up |
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| Secondary | Saturated Fat (Grams/Day) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | grams per day | 11-month follow-up |
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| Secondary | Total Fat (Grams/Day) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | grams per day | 11-month follow-up |
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| Secondary | Cholesterol Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | milligrams per day | 11-month follow-up |
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| Secondary | Fiber Intake | Self-reported, assessed via Block Brief Food Frequency Questionnaire. | Posted | Mean | Standard Deviation | grams per day | 11-month follow-up |
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| Secondary | Frequency of Moderate Intensity Physical Activity | Self-reported via Community Health Activities Model Program for Seniors questionnaire. | Posted | Median | Inter-Quartile Range | times per week | 11-month follow-up |
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| Secondary | Duration of Moderate Intensity Physical Activity | Self-reported via Community Health Activities Model Program for Seniors questionnaire. | Posted | Median | Inter-Quartile Range | hours per week | 11-month follow-up |
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| Secondary | Total Fat (%) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | percentage of calories | 11-month follow-up |
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| Secondary | Saturated Fat (%) | Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ). | Posted | Mean | Standard Deviation | percentage of calories | 11-month follow-up |
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| 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). | Posted | Number | participants | 11-month follow-up |
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| 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). | Posted | Number | participants | 11-month follow-up |
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| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | Usual Care | Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist. | 1 | 128 | 0 | 128 |
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| D009750 |
| Nutritional and Metabolic Diseases |