Heart Disease on the Mend

This study has been completed.
Sponsor:
Collaborator:
The Health Trust of Santa Clara County
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00127751
First received: August 5, 2005
Last updated: August 24, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Stroke
Hyperlipidemia
Hypertension
Behavioral: Enhance health lifestyle changes and medication compliance
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

Estimated Enrollment: 150
Study Start Date: May 2000
Estimated Study Completion Date: May 2003
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127751

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The Health Trust of Santa Clara County
Investigators
Principal Investigator: William L Haskell, PhD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127751     History of Changes
Other Study ID Numbers: 373765
Study First Received: August 5, 2005
Last Updated: August 24, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Risk factor reduction
cardiovascular disease prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hyperlipidemias
Hypertension
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014