Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321789
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-05-03
Brief Title:
A Patient-Spouse Intervention for Self-Managing High Cholesterol
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Patient-Spouse Intervention for Self-Managing High Cholesterol
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CouPLES
Brief 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
Detailed Description:
Background BackgroundRationale Coronary heart disease CHD is the leading cause of death in the United States resulting in more than 500000 heart attacks and another 50000 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 interventions 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
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 interventions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None