Benjamin Grobman , Christian Rivera , Mingyu Zhang , Ruth-Alma Turkson-Ocran , Jingyi Cao , Md Marufuzzaman Khan , Hannah Col , Marian Budu , Sarah Nartey , Ruth Zeto , Emily Aidoo , Timothy B. Plante , Stephen P. Juraschek
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引用次数: 0
Abstract
Background
Trial recruitment is a major determinant of study success, and participants' non-arrival at study visits represents a significant barrier to study completion. Little is known about the participant and study process characteristics associated with visit non-arrival.
Objective
To investigate factors associated with non-arrival at initial in-person screening visits in two ongoing randomized controlled trials.
Methods
The Groceries for Black Residents of Boston to Stop Hypertension trials (GoFresh and GoFreshRx) studied whether home-delivered, DASH-patterned groceries can reduce blood pressure among Black adults living in urban food priority areas. In this analysis, we examined sociodemographic and study-related factors associated with participant non-arrival at their initial study visit (defined as rescheduling or not showing up at all). Associations were determined using logistic regression with adjustment for age, estimated gender, and hypertension treatment status.
Results
Among 2224 participants (mean age = 44.0 years, 72.5 % women), the non-arrival rate at screening visit 1 was 29.5 %. Older participants were more likely to arrive, while those with larger families and a longer duration between initial contact and visit were less likely to arrive. Participants’ method of contacting the study, visit time, and season of visit were not associated with visit non-arrival.
Conclusion
In this large trial recruitment drive, older age, larger family size, and a longer time between initial contact and scheduled visit were associated with non-arrival at initial study visits. These factors represent potential targets for future interventions that either accommodate patient factors or intervene upon study process barriers to achieve timely recruitment goals.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.