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Two recruitment strategies for a clinical trial of physically frail community-living older persons
Authors:Gill T M  McGloin J M  Gahbauer E A  Shepard D M  Bianco L M
Affiliation:Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Abstract:OBJECTIVES: To compare the efficiency and cost of two distinct but complementary recruitment strategies for a clinical trial of physically frail, community-living persons, age 75 and older. DESIGN: In the first recruitment strategy, potential participants were identified and screened for physical frailty during office visits to their primary care physicians; in the second, potential participants were identified from the patient rosters of primary care physicians and were screened for physical frailty in their home. Physical frailty was defined on the basis of slow gait speed and inability to stand from a chair with one's arms folded. SETTING: General community in greater Bridgeport, Connecticut. PARTICIPANTS: Community-living persons, age 75 and older, who met criteria for physical frailty. MEASUREMENTS: Measures of efficiency included the number of persons screened for each participant randomized, the number of persons eligible for each participant randomized, and the refusal rate. Costs were calculated per randomized participant. RESULTS: One hundred eighty-eight participants, with a mean age of 83.2 years, were enrolled over 22 months. One hundred and one participants were enrolled via the office-based strategy; 87 were enrolled via the roster-based strategy. Participants in each group had considerable quadriceps weakness and performed poorly on objective measures of gait and upper- and lower-extremity function. For each participant randomized, the number of persons screened, number of persons eligible, and cost were 15.2, 1.2, and $868, respectively, for the office-based strategy and 11.6, 1.1, and $764, respectively, for the roster-based strategy. The corresponding refusal rates for the two strategies were 14.9% and 10.1%, respectively (P < .001). CONCLUSIONS: Although each recruitment strategy successfully identified older persons who were physically frail, the roster-based strategy was less expensive and performed modestly better on each measure of efficiency than the office-based strategy.
Keywords:clinical trials    recruitment    frail older people
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