Community-based recruitment and enrollment for a clinical trial on the sensitive issue of fecal incontinence: The Fiber Study

Robin R. Whitebird, Donna Zimmaro Bliss, Kirsten A. Hase, Kay Savik

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

Abstract

The recruitment of community-living participants for clinical trials of sensitive topics, when the population is largely hidden and reluctant to self-identify, and the study protocols and procedures intensive, creates significant challenges to researchers. The Fiber Study is an ongoing randomized controlled clinical trial conducted to compare the effectiveness of three dietary fibers with different levels of fermentability for symptom management in community-living adults with fecal incontinence. The researchers developed a staged approach to recruitment using three primary recruitment methods and a three-phase approach to the enrollment process. We have been successful in reaching, recruiting, and enrolling participants in a clinical trial, as well as in effectively managing study resources and staff time.

Original languageEnglish (US)
Pages (from-to)233-243
Number of pages11
JournalResearch in Nursing and Health
Volume29
Issue number3
DOIs
StatePublished - Jun 2006

Keywords

  • Enrollment
  • Fecal incontinence
  • Fiber
  • Methods
  • Recruitment

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