Author:
Sciamanna Christopher N.,Ballentine Noel H.,Bopp Melissa,Chinchilli Vernon M.,Ciccolo Joseph T.,Delauter Gabrielle,Fisher Abigail,Fox Edward J.,Jan De Beur Suzanne M.,Kearcher Kalen,Kraschnewski Jennifer L.,Lehman Erik,McTigue Kathleen M.,McAuley Edward,Paranjape Anuradha,Rodriguez-Colon Sol,Rovniak Liza S.,Rutt Kayla,Smyth Joshua M.,Stewart Kerry J.,Stuckey Heather L.,Tsay Annie
Abstract
Abstract
Background
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.
Methods
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.
Results
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%).
Conclusions
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.
Funder
Patient-Centered Outcomes Research Institute
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference41 articles.
1. Kramarow E, Chen LH, Hedegaard H, Warner M. Deaths from unintentional injury among adults aged 65 and over: United States, 2000-2013. NCHS Data Brief. 2015;199:199.
2. Ortman JM, Velkoff VA, Hogan H. An Aging Nation: The Older Population in the United States. U.S. Census Bureau: Washington, D.C; 2014.
3. Sciamanna C, Ballentine NH, Bopp M, Brach JS, Chinchilli VM, Ciccolo JT, et al. Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries. Contemp Clin Trials. 2018;74:1–10. https://doi.org/10.1016/j.cct.2018.09.006.
4. Huang GD, Bull J, Johnston McKee K, Mahon E, Harper B, Roberts JN, et al. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative. Contemp Clin Trials. 2018;66:74–9. https://doi.org/10.1016/j.cct.2018.01.003.
5. Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2(2):MR000013. https://doi.org/10.1002/14651858.MR000013.pub6.
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献