Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension—HAEL Study: a study within a trial

Cíntia E. Botton*, Lucas P. Santos, Bruna G. Moraes, Raíssa B. Monteiro, Maria Laura B. Gomes, Eurico N. Wilhelm, Stephanie S. Pinto, Daniel Umpierre

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background:
Although the prevalence of hypertension is high in older adults, clinical trial recruitment is a challenge. Our main aim was to describe the HAEL Study recruitment methods and yield rates. The secondary objectives were to explore the reasons for exclusion and to describe the characteristics of the enrolled participants.

Methods:
This is a descriptive study within a trial. The HAEL Study was a Brazilian randomized two-center, parallel trial with an estimated sample of 184 participants. The recruitment strategy was based on four methods: electronic health records, word of mouth, print and electronic flyer, and press media. The yield rate was the ratio of the number of participants who underwent randomization to the total number of volunteers screened, calculated for overall, per recruitment method, by study center and by age group and sex. Additionally, we described the reasons for exclusion in the screening phase, as well as the demographic characteristics of those enrolled. The data are presented in absolute/relative frequencies and mean ± standard deviation.

Results:
A total of 717 individuals were screened, and 168 were randomized over 32 months. The yield rate was higher for word of mouth (30.1%) in the overall sample. However, press media contributed the most (39.9%) to the absolute number of participants randomized in the trial. The coordinating center and participating center differed in methods with the highest yield ratios and absolute numbers of randomized participants. The main reason for exclusion in the screening phase was due to the physically active status in those intending to participate in the study (61.5%). Out of 220 participants included, 52 were excluded mainly because they did not meet the eligibility criteria (26.9%). Most of the screened volunteers were women (60.2%) age 60–69 years (59.5%), and most of the randomized participants were Caucasian/white (78.0%).

Conclusions:
Multiple recruitment methods constituted effective strategies. We observed that approximately one of every four individuals screened was allocated to an intervention group. Even so, there were limitations in obtaining a representative sample of older Brazilian adults with hypertension. Data show an underrepresentation of race and age groups.
Original languageEnglish
Article number42
Number of pages9
JournalBMC Medical Research Methodology
Volume22
Issue number1
Early online date10 Feb 2022
DOIs
Publication statusE-pub ahead of print - 10 Feb 2022

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