Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005344
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Mediators of Social Support in Coronary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
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:
None
Brief Summary:
To determine prospectively the extent to which structural and functional aspects of social support influences hard cardiac events such as death and non-fatal myocardial infarction in patients with coronary artery disease CAD and to identify the behavioral and biological mediators of these influences
Detailed Description:
BACKGROUND
Besides extending our understanding of the mechanisms of social support effects on health the findings of this project helped in the design and development of more effective and efficient approaches to secondary prevention in coronary artery disease
DESIGN NARRATIVE
Social support was assessed in a large consecutive cohort of coronary disease patients referred for diagnostic catheterization Group A and in a subgroup of medically treated patients Group B with severe coronary artery disease andor poor left ventricular function with an expected two year hard cardiac event rate death or nonfatal myocardial infarction of 25 percent or more A brief baseline questionnaire assessment of structural and functional aspects of social support as well as other aspects of quality of life was obtained on all coronary artery disease patients without prior revascularization who were referred to the Duke University Cardiac Catheterization Laboratory over a three year period Group A Detailed questionnaire and interview assessment of perceived and received social support and psychological traits that is hostility was obtained on a high risk subgroup Group B and a randomly selected 10 percent subgroup of other Group A patients Potential behavioral mediators including smoking behavior physical activity medical care utilization and biological mediatorsincluding vagal tone ambulatory ischemic burden of the social support effects on outcomes were measured in Group B patients and the random subset of Group A Group A patients were followed by mailed questionnaire at three months and one year and then annually Group B and the random subset of Group A returned for a one month clinic visit At that time repeat social support interviews were administered and patients were sent home with a 48 hour ambulatory ECG monitor to allow measurement of total ischemic burden and heart rate variability vagal tone
Group B patients and the random subset of Group A were then followed by telephone interview at one year and then annually In addition these patients had brief bimonthly telephone contacts to assess interval changes in social support as well as levels of environmental stress and mood states including depression and anger All patients were followed for up to three years Outcome events including death and myocardial infarction were ascertained at each point in follow-up Multivariable analyses using the spline proportional hazards regression model tested the prognostic importance of the social support and psychological measures on outcome and evaluated the role of biological and behavioral variables as mediators controlling for baseline disease severity
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Besides extending our understanding of the mechanisms of social support effects on health the findings of this project helped in the design and development of more effective and efficient approaches to secondary prevention in coronary artery disease
DESIGN NARRATIVE
Social support was assessed in a large consecutive cohort of coronary disease patients referred for diagnostic catheterization Group A and in a subgroup of medically treated patients Group B with severe coronary artery disease andor poor left ventricular function with an expected two year hard cardiac event rate death or nonfatal myocardial infarction of 25 percent or more A brief baseline questionnaire assessment of structural and functional aspects of social support as well as other aspects of quality of life was obtained on all coronary artery disease patients without prior revascularization who were referred to the Duke University Cardiac Catheterization Laboratory over a three year period Group A Detailed questionnaire and interview assessment of perceived and received social support and psychological traits that is hostility was obtained on a high risk subgroup Group B and a randomly selected 10 percent subgroup of other Group A patients Potential behavioral mediators including smoking behavior physical activity medical care utilization and biological mediatorsincluding vagal tone ambulatory ischemic burden of the social support effects on outcomes were measured in Group B patients and the random subset of Group A Group A patients were followed by mailed questionnaire at three months and one year and then annually Group B and the random subset of Group A returned for a one month clinic visit At that time repeat social support interviews were administered and patients were sent home with a 48 hour ambulatory ECG monitor to allow measurement of total ischemic burden and heart rate variability vagal tone
Group B patients and the random subset of Group A were then followed by telephone interview at one year and then annually In addition these patients had brief bimonthly telephone contacts to assess interval changes in social support as well as levels of environmental stress and mood states including depression and anger All patients were followed for up to three years Outcome events including death and myocardial infarction were ascertained at each point in follow-up Multivariable analyses using the spline proportional hazards regression model tested the prognostic importance of the social support and psychological measures on outcome and evaluated the role of biological and behavioral variables as mediators controlling for baseline disease severity
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL045702 | NIH | None | httpsreporternihgovquickSearchR01HL045702 |