Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128687
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2005-08-08
Brief Title:
Improving Coronary Prevention in a County Health System
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Improving Coronary Prevention in a County Health System
Status:
COMPLETED
Status Verified Date:
2014-02
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 examine whether the Stanford Health Education and Risk Reduction Training HEAR2T program a case management approach can be effectively used to manage the risk of coronary artery disease
Detailed Description:
BACKGROUND
Evidence from extensive population studies and clinical trials shows the effectiveness of risk factor management in reducing morbidity and mortality from coronary artery disease CAD These studies have generated important national clinical practice guidelines Current prevention practices however fall short of attaining the goals recommended in these national guidelines These shortfalls lead to unnecessary CAD disease burden as well as perpetuation of socioeconomic disparities Case management proves to augment current CAD prevention activities and improve adherence with national guidelines The Stanford Health Education and Risk Reduction Training HEAR2T program is an innovative yet well-tested case management tool which will be evaluated in this study HEAR2T has been developed and evaluated in several studies at Stanford It is based upon the social cognitive model of Bandura and uses case managers to work intensely with patients to educate them and change their overall behavior related to health
DESIGN NARRATIVE
The Stanford Health Education and Risk Reduction Training HEAR2T program will be evaluated in a high-risk population of low socioeconomic status SES served by the county health care system of San Mateo County SMC California The study will 1 enhance the HEAR2T program for use in low-SES populations 2 implement this program as an integral part of clinical care 3 implement a randomized controlled trial to evaluate the effectiveness of HEAR2T in lowering aggregate CAD risk 4 determine if HEAR2T diminishes socioeconomic disparities 5 estimate HEAR2Ts cost effectiveness and 6 transition the intervention from a research study to an ongoing County CAD case management program The primary outcome measure will be change in aggregate CAD risk score calculated from a Framingham model based on individual CAD risk factors The primary hypothesis is that patients case-management via the HEAR2T model will produce favorable changes in aggregate CAD risk score compared to control patients in usual care An estimated 200 intervention and 200 usual care patients will be enrolled from four health centers in the SMC system Usual care patients will crossover to the intervention after 15 months allowing for additional assessment of the interventions impact Continued follow-up of the participants will assess the durability of risk changes achieved during initial intensive case-management This study will make a critical and innovative contribution to defining optimal disease management in a low-SES population
Evidence from extensive population studies and clinical trials shows the effectiveness of risk factor management in reducing morbidity and mortality from coronary artery disease CAD These studies have generated important national clinical practice guidelines Current prevention practices however fall short of attaining the goals recommended in these national guidelines These shortfalls lead to unnecessary CAD disease burden as well as perpetuation of socioeconomic disparities Case management proves to augment current CAD prevention activities and improve adherence with national guidelines The Stanford Health Education and Risk Reduction Training HEAR2T program is an innovative yet well-tested case management tool which will be evaluated in this study HEAR2T has been developed and evaluated in several studies at Stanford It is based upon the social cognitive model of Bandura and uses case managers to work intensely with patients to educate them and change their overall behavior related to health
DESIGN NARRATIVE
The Stanford Health Education and Risk Reduction Training HEAR2T program will be evaluated in a high-risk population of low socioeconomic status SES served by the county health care system of San Mateo County SMC California The study will 1 enhance the HEAR2T program for use in low-SES populations 2 implement this program as an integral part of clinical care 3 implement a randomized controlled trial to evaluate the effectiveness of HEAR2T in lowering aggregate CAD risk 4 determine if HEAR2T diminishes socioeconomic disparities 5 estimate HEAR2Ts cost effectiveness and 6 transition the intervention from a research study to an ongoing County CAD case management program The primary outcome measure will be change in aggregate CAD risk score calculated from a Framingham model based on individual CAD risk factors The primary hypothesis is that patients case-management via the HEAR2T model will produce favorable changes in aggregate CAD risk score compared to control patients in usual care An estimated 200 intervention and 200 usual care patients will be enrolled from four health centers in the SMC system Usual care patients will crossover to the intervention after 15 months allowing for additional assessment of the interventions impact Continued follow-up of the participants will assess the durability of risk changes achieved during initial intensive case-management This study will make a critical and innovative contribution to defining optimal disease management in a low-SES population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070781 | NIH | None | httpsreporternihgovquickSearchR01HL070781 |