Heart Disease on the Mend

Stanford University

Status and phase: Completed; Phase 2

Conditions: Hypertension; Hyperlipidemia; Stroke; Coronary Heart Disease

Treatments: Behavioral: Enhance health lifestyle changes and medication compliance

Study type: Interventional

Funder types: Other

Identifiers

NCT00127751

373765

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)