Practical issues regarding implementing a randomized clinical trial in a homeless population: Strategies and lessons learned

Olamide Ojo-Fati, Anne M Joseph, Jed Ig-Izevbekhai, Janet L Thomas, Susan Everson-Rose, Rebekah J Pratt, Nancy C Raymond, Ned L. Cooney, Xianghua Luo, Kola Okuyemi

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. Trial registration: ClinicalTrials.gov, ID: NCT00786149. Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996. Registered on 20 November 2014.

Original languageEnglish (US)
Article number305
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Jul 5 2017

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Randomized Controlled Trials
Research Personnel
Population
Clinical Trials
Homeless Persons
Clothing
Smoking Cessation
Health Promotion
Substance-Related Disorders
Mental Health
Delivery of Health Care
Safety
Food
Research

Keywords

  • Attrition
  • Clinical trials
  • Community-based
  • Homeless adults
  • Retention
  • Smoking cessation

Cite this

Practical issues regarding implementing a randomized clinical trial in a homeless population : Strategies and lessons learned. / Ojo-Fati, Olamide; Joseph, Anne M; Ig-Izevbekhai, Jed; Thomas, Janet L; Everson-Rose, Susan; Pratt, Rebekah J; Raymond, Nancy C; Cooney, Ned L.; Luo, Xianghua; Okuyemi, Kola.

In: Trials, Vol. 18, No. 1, 305, 05.07.2017.

Research output: Contribution to journalArticle

Ojo-Fati, Olamide ; Joseph, Anne M ; Ig-Izevbekhai, Jed ; Thomas, Janet L ; Everson-Rose, Susan ; Pratt, Rebekah J ; Raymond, Nancy C ; Cooney, Ned L. ; Luo, Xianghua ; Okuyemi, Kola. / Practical issues regarding implementing a randomized clinical trial in a homeless population : Strategies and lessons learned. In: Trials. 2017 ; Vol. 18, No. 1.
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