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

Journal: Research in nursing & health 2006;29(3):233-43

PMID: 16676338

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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.

Address: HealthPartners Research Foundation, Minneapolis, Minnesota 55440-1524, USA.

DOI: 10.1002/nur.20131

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MeSH Terms: Adult, Attitude to Health, Dietary Fiber, Fecal Incontinence, Fermentation, Humans, Informed Consent, Managed Care Programs, Mass Screening, Minnesota, Motivation, Nursing Methodology Research, Patient Dropouts, Patient Selection, Randomized Controlled Trials as Topic, Referral and Consultation, Research Design, Researcher-Subject Relations, Shame, Single-Blind Method, Stereotyping