Gerontology Center, Schiefelbush Institute for Life Span Studies, The University of Kansas, 1000 Sunnyside, Dole 3090, Lawrence, KS 66045, United States.
Contemp Clin Trials. 2011 Mar;32(2):188-95. doi: 10.1016/j.cct.2010.10.010. Epub 2010 Oct 27.
This paper describes recruitment challenges and lessons learned in conducting a randomized controlled exercise trial in the absence of direct access to a clinical population. One-hundred thirty-five wheelchair users were enrolled in a home and community-based intervention to promote exercise adoption and maintenance. Over 44 months of recruitment, 355 individuals inquired about the study and 323 completed the screening process. Nearly half were determined ineligible (150/323, 46.4%), typically due to having restricted arm movement, cognitive impairment, or medical conditions that are contraindicated for unsupervised exercise. Respondents cited paid media advertisements and recruitment materials placed in health care providers' offices most frequently as being how they learned about the study. RCT participant recruitment, particularly in the absence of direct access to a clinical population, required far more time and resources than anticipated to achieve sufficient enrollment. Nurturing relations with key gatekeepers, creating a visible public profile, and maintaining ongoing recruitment activities were essential to success.
本文描述了在无法直接接触临床人群的情况下进行随机对照运动试验所面临的招募挑战和吸取的经验教训。135 名轮椅使用者参与了一项以家庭和社区为基础的干预措施，以促进运动的采用和维持。在 44 个月的招募过程中，有 355 人询问了这项研究，有 323 人完成了筛选过程。近一半的人被确定为不合格（150/323，46.4%），通常是因为手臂活动受限、认知障碍或有医学禁忌症，不适合无人监督的运动。受访者表示，他们最常通过付费媒体广告和在医疗保健提供者办公室放置的招募材料了解到这项研究。特别是在无法直接接触临床人群的情况下，RCT 参与者的招募需要比预期多得多的时间和资源才能达到足够的入组人数。与关键把关人建立关系、树立可见的公众形象和保持持续的招募活动对于成功至关重要。
