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

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  • Additional Information
    • Affiliation:
      Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St SE, Suite 166, Minneapolis, MN 55414, USA
      Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN 55414, USA
      Department of Medicine, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN 55414, USA
      Department of Psychiatry, University of Minnesota Medical School, 2450 Riverside Ave., F282/2AW, Minneapolis, MN 55454, USA
      Department of Psychiatry, Yale University School of Medicine, 300 George St., Suite 901, New Haven, CT 06511, USA
      Division of Biostatistics, School of Public Health, University of Minnesota, 420 Delaware Street SE, Minneapolis, MN 55455, USA
      Biostatistics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA
      Department of Family & Preventive Medicine, University of Utah, 375 Chipeta, Suite A, Salt Lake, UT 84108, USA
      Division of Biostatistics, School of Public Health, University of Minnesota, 420 Delaware Street SE, Minneapolis, MN, 55455, USA
      Biostatistics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, 55455, USA
    • Subject Terms:
    • Subject Terms:
    • 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.
    • Journal Subset:
      Biomedical; Europe; UK & Ireland
    • Special Interest:
      Evidence-Based Practice
    • Instrumentation:
      Ferrans and Powers Quality of Life Index
      Clinical Decision Making in Nursing Scale (CDMNS) (Jenkins)
    • ISSN:
      1745-6215
    • MEDLINE Info:
      PMID: NLM28679430 NLM UID: 101263253
    • Grant Information:
      T32 CA163184/CA/NCI NIH HHS/United States; R25 CA163184/CA/NCI NIH HHS/United States; P30 CA077598/CA/NCI NIH HHS/United States; R01 HL081522/HL/NHLBI NIH HHS/United States; UL1 TR002494/TR/NCATS NIH HHS/United States
    • Publication Date:
      In Process
    • Publication Date:
      20190929
    • DOI:
      http://dx.doi.org/10.1186/s13063-017-2046-9
    • Accession Number:
      123960008
  • Citations
    • ABNT:
      OJO-FATI, O. et al. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials, [s. l.], v. 18, p. 1–10, 2017. DOI 10.1186/s13063-017-2046-9. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=123960008. Acesso em: 8 ago. 2020.
    • AMA:
      Ojo-Fati O, Joseph AM, Ig-Izevbekhai J, et al. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials. 2017;18:1-10. doi:10.1186/s13063-017-2046-9
    • APA:
      Ojo-Fati, O., Joseph, A. M., Ig-Izevbekhai, J., Thomas, J. L., Everson-Rose, S. A., Pratt, R., Raymond, N., Cooney, N. L., Xianghua Luo, Okuyemi, K. S., & Luo, X. (2017). Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials, 18, 1–10. https://doi.org/10.1186/s13063-017-2046-9
    • Chicago/Turabian: Author-Date:
      Ojo-Fati, Olamide, Anne M. Joseph, Jed Ig-Izevbekhai, Janet L. Thomas, Susan A. Everson-Rose, Rebekah Pratt, Nancy Raymond, et al. 2017. “Practical Issues Regarding Implementing a Randomized Clinical Trial in a Homeless Population: Strategies and Lessons Learned.” Trials 18 (July): 1–10. doi:10.1186/s13063-017-2046-9.
    • Harvard:
      Ojo-Fati, O. et al. (2017) ‘Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned’, Trials, 18, pp. 1–10. doi: 10.1186/s13063-017-2046-9.
    • Harvard: Australian:
      Ojo-Fati, O, Joseph, AM, Ig-Izevbekhai, J, Thomas, JL, Everson-Rose, SA, Pratt, R, Raymond, N, Cooney, NL, Xianghua Luo, Okuyemi, KS & Luo, X 2017, ‘Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned’, Trials, vol. 18, pp. 1–10, viewed 8 August 2020, .
    • MLA:
      Ojo-Fati, Olamide, et al. “Practical Issues Regarding Implementing a Randomized Clinical Trial in a Homeless Population: Strategies and Lessons Learned.” Trials, vol. 18, July 2017, pp. 1–10. EBSCOhost, doi:10.1186/s13063-017-2046-9.
    • Chicago/Turabian: Humanities:
      Ojo-Fati, Olamide, Anne M. Joseph, Jed Ig-Izevbekhai, Janet L. Thomas, Susan A. Everson-Rose, Rebekah Pratt, Nancy Raymond, et al. “Practical Issues Regarding Implementing a Randomized Clinical Trial in a Homeless Population: Strategies and Lessons Learned.” Trials 18 (July 5, 2017): 1–10. doi:10.1186/s13063-017-2046-9.
    • Vancouver/ICMJE:
      Ojo-Fati O, Joseph AM, Ig-Izevbekhai J, Thomas JL, Everson-Rose SA, Pratt R, et al. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials [Internet]. 2017 Jul 5 [cited 2020 Aug 8];18:1–10. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=123960008