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Heart Disease on the Mend

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127751
Enrollment
150
Registered
2005-08-08
Start date
2000-05-31
Completion date
2003-05-31
Last updated
2005-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Hyperlipidemia, Hypertension, Stroke

Keywords

Risk factor reduction, cardiovascular disease 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.

Interventions

BEHAVIORALEnhance health lifestyle changes and medication compliance

Sponsors

The Health Trust of Santa Clara County
CollaboratorUNKNOWN
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cardiovascular disease risk score
Low-density lipoprotein (LDL)-cholesterol
Systolic blood pressure

Secondary

MeasureTime frame
Body mass index (BMI)
Physical activity score
Nutrition score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026