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REPORTING OF ADVERSE EVENTS IN BEHAVIORAL INTERVENTION TRIALS: THE TAILORED ACTIVITY PROGRAM
Journal article   Open access   Peer reviewed

REPORTING OF ADVERSE EVENTS IN BEHAVIORAL INTERVENTION TRIALS: THE TAILORED ACTIVITY PROGRAM

Daniel Scerpella, Danny L Scerpella, Katherine A Marx and Laura N Gitlin
Innovation in aging, v 3(Suppl 1), pp S183-S183
08 Nov 2019
url
https://academic.oup.com/innovateage/article-pdf/3/Supplement_1/S183/33005016/igz038.652.pdfView
Published, Version of Record (VoR) Open
url
https://doi.org/10.1093/geroni/igz038.652View
Published, Version of Record (VoR) Open

Abstract

Session 1000 (Symposium)
Adverse events (AE) are not regularly reported in behavioral research, especially when compared to similar reporting in pharmacological research. AE reporting is crucial for understanding the potential risks and outcomes of behavioral interventions as well as characterizing the study population. This presentation presents AE findings of a behavioral intervention to reduce neuropsychiatric behaviors in persons living with dementia, the Tailored Activity Program. A total of 250 dyads (persons living with dementia and caregivers) living in a community setting participated in this intervention, reporting 126 adverse events and 37 alerts. None of the events were attributable to the intervention, with the majority (46%) being related to the health of the person living with dementia or high depression scores in caregivers (19%). These results are analyzed in relation to outcomes and the potential frailty of this study population. Reporting AEs in behavioral trials is the best opportunity to inform treatment options.

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