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Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension-HAEL Study: a study within a trial.
Botton, Cíntia E; Santos, Lucas P; Moraes, Bruna G; Monteiro, Raíssa B; Gomes, Maria Laura B; Wilhelm, Eurico N; Pinto, Stephanie S; Umpierre, Daniel.
  • Botton CE; National Institute of Science and Technology for Health Technology Assessment (IATS), Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. cintiaebotton@gmail.com.
  • Santos LP; Exercise Pathophysiology Research Laboratory, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. cintiaebotton@gmail.com.
  • Moraes BG; Institute of Physical Education and Sports, Federal University of Ceará, Fortaleza, CE, Brazil. cintiaebotton@gmail.com.
  • Monteiro RB; Exercise Pathophysiology Research Laboratory, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
  • Gomes MLB; Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, RS, Brazil.
  • Wilhelm EN; Exercise Pathophysiology Research Laboratory, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
  • Pinto SS; Exercise Pathophysiology Research Laboratory, Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.
  • Umpierre D; Neuromuscular Evaluation Laboratory, Universidade Federal de Pelotas, Pelotas, RS, Brazil.
BMC Med Res Methodol ; 22(1): 42, 2022 02 10.
Article in English | MEDLINE | ID: covidwho-1753105
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. TRIAL REGISTRATION This SWAT was not registered.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Hypertension Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Middle aged Country/Region as subject: South America / Brazil Language: English Journal: BMC Med Res Methodol Journal subject: Medicine Year: 2022 Document Type: Article Affiliation country: S12874-022-01535-7

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Hypertension Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Aged / Female / Humans / Middle aged Country/Region as subject: South America / Brazil Language: English Journal: BMC Med Res Methodol Journal subject: Medicine Year: 2022 Document Type: Article Affiliation country: S12874-022-01535-7