Heart Disease on the Mend
Primary Purpose
Coronary Heart Disease, Stroke, Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhance health lifestyle changes and medication compliance
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Risk factor reduction, cardiovascular disease prevention
Eligibility Criteria
Inclusion Criteria: Men and women ≥ 35 years One or more major risk factors Live in Santa Clara County Low family income that limits access to medical care Exclusion Criteria: Under active medical treatment for cancer, CVD or other major medical disorder Reasonable access to health care Under 35 years of age Not a resident of Santa Clara County
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Cardiovascular disease risk score
Low-density lipoprotein (LDL)-cholesterol
Systolic blood pressure
Secondary Outcome Measures
Body mass index (BMI)
Physical activity score
Nutrition score
Full Information
NCT ID
NCT00127751
First Posted
August 5, 2005
Last Updated
August 24, 2005
Sponsor
Stanford University
Collaborators
The Health Trust of Santa Clara County
1. Study Identification
Unique Protocol Identification Number
NCT00127751
Brief Title
Heart Disease on the Mend
Official Title
A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
The Health Trust of Santa Clara County
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Stroke, Hyperlipidemia, Hypertension
Keywords
Risk factor reduction, cardiovascular disease prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Enhance health lifestyle changes and medication compliance
Primary Outcome Measure Information:
Title
Cardiovascular disease risk score
Title
Low-density lipoprotein (LDL)-cholesterol
Title
Systolic blood pressure
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Title
Physical activity score
Title
Nutrition score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women ≥ 35 years
One or more major risk factors
Live in Santa Clara County
Low family income that limits access to medical care
Exclusion Criteria:
Under active medical treatment for cancer, CVD or other major medical disorder
Reasonable access to health care
Under 35 years of age
Not a resident of Santa Clara County
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William L Haskell, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Heart Disease on the Mend
We'll reach out to this number within 24 hrs