Department of Medicine, Division of General Internal Medicine, Penn State College of Medicine, Box HO34, 500 University Drive, Hershey, PA, 17033, USA.
Penn State College of Medicine, Hershey, USA.
Trials. 2021 Nov 15;22(1):809. doi: 10.1186/s13063-021-05761-0.
The aim of this paper is to describe the utility of various recruitment modalities utilized in the Working to Increase Stability through Exercise (WISE) study. WISE is a pragmatic randomized trial that is testing the impact of a 3-year, multicomponent (strength, balance, aerobic) physical activity program led by trained volunteers or delivered via DVD on the rate of serious fall-related injuries among adults 65 and older with a past history of fragility fractures (e.g., vertebral, fall-related). The modified goal was to recruit 1130 participants over 2 years in three regions of Pennsylvania.
The at-risk population was identified primarily using letters mailed to patients of three health systems and those over 65 in each region, as well as using provider alerts in the health record, proactive recruitment phone calls, radio advertisements, and presentations at community meetings.
Over 24 months of recruitment, 209,301 recruitment letters were mailed, resulting in 6818 telephone interviews. The two most productive recruitment methods were letters (72% of randomized participants) and the research registries at the University of Pittsburgh (11%). An average of 211 letters were required to be mailed for each participant enrolled. Of those interviewed, 2854 were ineligible, 2,825 declined to enroll and 1139 were enrolled and randomized. Most participants were female (84.4%), under age 75 (64.2%), and 50% took an osteoporosis medication. Not having a prior fragility fracture was the most common reason for not being eligible (87.5%). The most common reason provided for declining enrollment was not feeling healthy enough to participate (12.6%).
The WISE study achieved its overall recruitment goal. Bulk mailing was the most productive method for recruiting community-dwelling older adults at risk of serious fall-related injury into this long-term physical activity intervention trial, and electronic registries are important sources and should be considered.
本文旨在描述 Working to Increase Stability through Exercise（WISE）研究中使用的各种招募方式的效用。WISE 是一项实用的随机试验，旨在测试由经过培训的志愿者领导的为期 3 年、多组分（力量、平衡、有氧运动）的体育活动计划，或通过 DVD 提供的对有既往脆性骨折（如脊椎、与跌倒相关）病史的 65 岁及以上成年人严重跌倒相关伤害发生率的影响。修改后的目标是在宾夕法尼亚州的三个地区在 2 年内招募 1130 名参与者。
高危人群主要通过向三个医疗系统的患者和每个地区的 65 岁以上患者邮寄信件，以及在医疗记录中使用提供者警报、主动招募电话、广播广告和社区会议上的演讲来识别。
在 24 个月的招募过程中，共邮寄了 209301 封招募信，导致 6818 次电话访谈。两种最有效的招募方法是信件（72%的随机参与者）和匹兹堡大学的研究登记处（11%）。平均需要邮寄 211 封信件才能招募到每位参与者。在接受访谈的人中，2854 人不符合条件，2825 人拒绝参加，1139 人参加并随机分组。大多数参与者为女性（84.4%），年龄在 75 岁以下（64.2%），50%服用骨质疏松症药物。不符合条件的最常见原因是没有既往脆性骨折（87.5%）。拒绝参加的最常见原因是感觉自己身体不够健康，无法参加（12.6%）。
WISE 研究达到了总体招募目标。批量邮寄是招募有严重跌倒相关伤害风险的社区居住老年人参加这项长期体育活动干预试验的最有效方法，电子登记处是重要的来源，应予以考虑。
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