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Heart Disease on the Mend

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ClinicalTrials.gov Identifier: NCT00127751
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : August 25, 2005
Sponsor:
Collaborator:
The Health Trust of Santa Clara County
Information provided by:
Stanford University

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.

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

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 Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
Study Start Date : May 2000
Study Completion Date : May 2003



Primary Outcome Measures :
  1. Cardiovascular disease risk score
  2. Low-density lipoprotein (LDL)-cholesterol
  3. Systolic blood pressure

Secondary Outcome Measures :
  1. Body mass index (BMI)
  2. Physical activity score
  3. Nutrition score


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00127751     History of Changes
Other Study ID Numbers: 373765
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: August 25, 2005
Last Verified: August 2005

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases