Recruitment experience in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

Several approaches for recruitment of African American adults with renal insufficiency due to hypertension (glomerular filtration rate between 25 and 70 ml/min/1.73 m2) were explored in the Pilot Study for the African American Study of Kidney Disease and Hypertension (AASK). Over a period of 42 weeks, prescreening information was obtained on 2880 individuals, of whom 498 (17%) were evaluated at a screening visit. Two hundred and twenty-five (8%) had an 125I-iothalamate assessment of glomerular filtration rate. Ninety-four of 97 participants who met all the study eligibility criteria were enrolled in the trial. The most common reasons for ineligibility during screening were absence of renal insufficiency or hypertension, presence of diabetes mellitus, and a body mass index above the acceptable level. Overall, an average of 31 prescreen contacts and 8 screening visits were conducted for every randomization (3.3% yield from prescreening to randomization). Screening in clinical practice was the most efficient method for recruitment (12.6% yield from prescreen contact to randomization compared to 1.1% from mass mailing campaigns, 1.3% from mass media campaigns, and 1.7% from referrals by patients with end-stage renal disease). Randomization yields increased with progressively higher age ranges (2.4%, 3.3%, and 6.0% prescreen to randomization yields for those aged < or = 50, 51-60, and 61-70, respectively). A slight majority (51%) of the prescreen contacts were women, but 75% of the randomized participants were men. Our results suggest that clinic-based screening is an effective approach for recruitment of African Americans with hypertension and renal insufficiency into clinical trials. They also suggest that enrollment of African American women in such studies is a special challenge.

Participant satisfaction in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study.

Seventy-one of the 94 eligible participants of the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study completed a self-administered questionnaire at the end of the study to determine their satisfaction with the study, difficulties encountered during participation, and willingness to join a similar study in the future. Nearly all of the participants (97%) believed that they would directly benefit from the study; treatment and information from physicians (94%), and more knowledge (92%) and closer monitoring (90%) of their physical condition were often cited as the ways in which the AASK Pilot Study helped. The two most commonly reported problems in the study were side effects from antihypertensive drugs (27%) and travel to and from the clinic (25%). Eighty-two percent of those who completed the survey indicated that they would volunteer for a similar study in the future. We conclude that AASK Pilot Study participants believed that they would benefit directly from the trial and that medical aspects of the trial were of major importance. Side effects from antihypertensive drugs and difficulties in travel to and from the clinic were commonly encountered problems and may hinder long-term participation in the AASK Full-Scale Trial.