Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127751
Status:
COMPLETED
Last Update Posted:
2005-08-25
First Post:
2005-08-05
Brief Title:
Heart Disease on the Mend
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
Status:
COMPLETED
Status Verified Date:
2005-08
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:
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease CVD risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care Patients were randomized to case management 99 or usual care 49 with baseline 6-month and 12-month evaluations of CVD risk factors clinical status and quality of life
Detailed Description:
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease CVD risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care Patients were randomized to case management 99 or usual care 49 with baseline 6-month and 12-month evaluations of CVD risk factors clinical status and quality of life Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California Primary eligibility was 35 years of age one or more CVD risk factors with or without clinical CVD low family income and residing in Santa Clara County Patients in the case management group were provided counseling services by specially trained registered nurses RNs and registered dieticians RDs and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized On average patients in case management were seen by staff 6-9 in the 12 months
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