Skip to main content
OpenTrials
Completed

NCT Number: NCT00127751

Heart Disease on the Mend

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhance health lifestyle changes and medication compliance

Behavioral

Primary outcomes

  1. Cardiovascular disease risk score

  2. Low-density lipoprotein (LDL)-cholesterol

  3. Systolic blood pressure

Secondary outcomes

  1. Body mass index (BMI)

  2. Physical activity score

  3. Nutrition score

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • The Health Trust of Santa Clara County

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2003
First posted
Aug 8, 2005
Registry last updated
Aug 25, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.