Heart Disease on the Mend - HDOM
The goal of the trial was to evaluate if a multifactor risk-reduction program for cardiovascular disease works as well in low-income, ethnic-minority populations compared with similar initiatives in more affluent communities.
Patients Screened: 725
Patients Enrolled: 148
Mean Follow Up: 12 months for initial therapy; 12 months for crossover therapy
Mean Patient Age: Mean age 59 years
Age 35-80 years; low income with no or limited insurance; and one or more risk factors for coronary disease or stroke, including high blood pressure, high cholesterol, cigarette smoking, elevated glucose, or diabetes
Significant coronary disease or other major medical problems
Changes in SBC and LDL-C from baseline
Changes in nutrition, physical-activity scores, and quality of life
Patients were randomized in a 1:2 ratio to usual care (n=49) or usual care plus case management (n=99). After 12 months on the initial randomization therapy, patients were crossed over to the opposite treatment.
Case management involved lifestyle recommendations and medical management of major risk factors following current US guidelines from a physician-direct nurse and dietician who spoke the language of the patient. Lifestyle management included smoking cessation, counseling on nutrition and exercise, weight management, and stress management.
The present data report on only the first 12 months of follow-up prior to the crossover therapy. Follow-up was complete in 42/49 patients in the usual care arm and 93/99 patients in the intervention arm. Patients had an average of six clinic visits during the one-year follow-up, which lasted approximately 60 minutes each.
Sixty-four percent of patients did not have any insurance. English was the primary language in 18% of patients, and 45% of patients spoke no English.
The primary endpoint of low-density lipoprotein cholesterol (LDL-C) was lower at follow-up in patients in the intervention group (104 mg/dl) versus usual care (116 mg/dl, p=0.01). The coprimary endpoint of systolic blood pressure (SBP) was also reduced in the intervention group (128 mm Hg vs. 137 mm Hg, p=0.001).
Other reductions in the intervention group versus the placebo group included total cholesterol (184 mg/dl vs. 199 mg/dl, p=0.01), triglycerides (174 mg/dl vs. 193 mg/dl, p=0.06), fasting glucose (129 mg/dl vs. 142 mg/dl, p=0.01), physical activity risk score (7.9 vs. 11.6, p=0.02), and nutrition risk score (13.0 vs. 14.7). There was no difference between the treatment groups in body mass index or stress reduction.
Among low-income, ethnic-minority patients with minimal or no insurance and at least one cardiac risk factor, use of a multifactor risk-reduction program for cardiovascular disease was associated with improvements in the primary endpoints of LDL-C and SBP at 12-month follow-up compared with patients treated with usual care. Prior risk reduction intervention trials have not targeted low-income and minority patients, and have primarily been conducted in more affluent patients, many with private insurance.
An additional notable finding was the high percent of patients in both treatment arms with complete follow-up (94% in the intervention arm and 86% in the usual care arm) and good compliance. Data from the crossover phase of the study have yet to be reported.
Presented by Dr. William Haskell at the November 2003 American Heart Association Annual Scientific Session, Orlando, FL.
Keywords: Stroke, Life Style, Coronary Disease, Blood Pressure, Risk Factors, Glucose, Lipoproteins, LDL, Cholesterol, Body Mass Index, Language, Case Management, Motor Activity, Nutritionists, Triglycerides, Hypertension, Smoking Cessation, Diabetes Mellitus, Fasting
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