Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE)

Abstract

Objective: To compare the effectiveness of different approaches to participant enrollment in a behavior modification trial.

Design: Concurrent, prospective evaluation performed in context of recruitment for a randomized, controlled trial.

Setting: Four study centers located in Baltimore, Maryland, Memphis, Tennessee New Brunswick, New Jersey, and Winston-Salem, North Carolina.

Participants: Men and women aged 60 to 80 years who were being treated with a prescription medication for control of hypertension.

Main outcome measures: Visit counts and percent yields were assessed at each stage of the screening and randomization process. Logistic regression was used to contrast the randomization yields for different recruitment strategies and to explore the impact of sociodemographic characteristics and geographic location on recruitment yields.

Results: The overall randomization yields from a prescreen contact and a first screening visit to enrollment in the trial were 11% and 31%, respectively. Randomization yields varied significantly by participant age, education, and marital status.

Conclusions: Our results demonstrate the feasibility of recruitment for trials of nonpharmacologic interventions in older people and suggest that mass mailing and mass media advertising campaigns provide an effective means of enrolling in such studies participants with a broad range of personal characteristics.