The successful recruitment of elderly black subjects in a clinical trial: the CRISP experience. Cholesterol Reduction in Seniors Program.

This article describes the recruitment of elderly black subjects into the Cholesterol Reduction in Seniors Program (CRISP), a federal, multi-center, randomized, double-masked feasibility study of cholesterol intervention in the elderly. The study tested the feasibility of recruiting significant numbers of hypercholesterolemic black men, black women, and white women over the age of 65, groups previously underrepresented in federal trials. The study involved dietary modification and drug intervention with either 20 mg or 40 mg of lovastatin or placebo. Maximum follow-up was 18 months. Over the 12-month screening and recruitment period, 431 subjects (108% of the recruitment goal) were randomized. A total of 311 (72% of the study cohort) was female; 105 subjects (24% of the total cohort) were minorities. Media sources were most effective in recruiting white subjects. Church screening was an effective strategy in the black community, although such an approach required considerable resources s and time. The CRISP feasibility study demonstrated that a large cohort of elderly black subjects could be recruited in a cholesterol intervention trial, although the use of community-based approaches required substantial resources and staff time.