Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial

Maria I Danila, Ryan C Outman, Elizabeth J Rahn, Amy S Mudano, David T Redden, Peng Li, Jeroan J Allison, Fred A Anderson, Allison Wyman, Susan L Greenspan, Andrea Z LaCroix, Jeri W Nieves (+8 others)
2018 Journal of Bone and Mineral Research  
Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2,684 women with self-reported fracture history after age 45 not using osteoporosis therapy from U.S. Global Longitudinal study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to
more » ... eceive a multi-modal, tailored, direct-to-patient, video intervention vs. usual care. The primary study outcome was self-report of osteoporosis medication use at 6months. Other outcomes included calcium and vitamin D supplementation, bone mineral density Methods Study Design and Participants The APROPOS study was a parallel, controlled, randomized clinical trial, in which participants received either usual care alone (control group), or in combination with a multimodal, patient-tailored, behavioral intervention (intervention group). (16) APROPOS was nested within the GLOW cohort, (40) an international, prospective, observational study of women 55+ years of age. The participants in APROPOS were enrolled from 7 U.S. GLOW sites (Birmingham, AL; Los Angeles, CA; Worcester, MA; New York, NY; Cincinnati, OH; Pittsburgh, PA; Seattle, WA). Human subject protocols and consent procedures were reviewed and approved by each site's Institutional Review Board. GLOW participants were preliminarily eligible for APROPOS if on one of the five GLOW surveys they self-reported a fracture after age 45. In September 2013, we mailed baseline questionnaires to 4,928 preliminarily eligible GLOW participants; 3,226 (64%) completed baseline surveys, of which 2,684 women, who did not report currently using osteoporosis medication (the second eligibility criteria) besides estrogen, formed the APROPOS study population, and were randomized. Danila et al.
doi:10.1002/jbmr.3395 pmid:29377378 pmcid:PMC6016546 fatcat:fttvj552ijf7fhvvu2quaui43i