Clinical trial NCT00127751: Heart Disease on the Mend
Official title: A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Stroke
Hyperlipidemia
Hypertension
Keywords: Risk factor reduction
cardiovascular disease prevention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Health Trust of Santa Clara County
First posted: 2005-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cardiovascular disease risk score
measure: Low-density lipoprotein (LDL)-cholesterol
measure: Systolic blood pressure
Secondary outcomes:
measure: Body mass index (BMI)
measure: Physical activity score
measure: Nutrition score
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: William L Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References: