Heart Disease on the Mend

Stroke Clinical Trial

Official title:

A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127751
• Other study ID #: 373765
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2005
• Last updated: August 24, 2005
• Start date: May 2000
• Est. completion date: May 2003

Study information

• Verified date: August 2005
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Myocardial Ischemia
• Stroke

Intervention

Behavioral:
• Enhance health lifestyle changes and medication compliance

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	The Health Trust of Santa Clara County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease risk score
Primary	Low-density lipoprotein (LDL)-cholesterol
Primary	Systolic blood pressure
Secondary	Body mass index (BMI)
Secondary	Physical activity score
Secondary	Nutrition score