title: Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial.
abstract: Among over 5million people in the USA with dementia, neuropsychiatric symptoms (NPS) are almost universal, occurring across disease etiology and stage. If untreated, NPS can lead to significant morbidity and mortality including increased cost, distress, depression, and faster disease progression, as well as heightened burden on families. With few pharmacological solutions, identifying nonpharmacologic strategies is critical. We describe a randomized clinical trial, the Dementia Behavior Study, to test the efficacy of an activity program to reduce significant existing NPS and associated caregiver burden at 3 and 6months compared to a control group intervention. Occupational therapists deliver 8 in-home sessions over 3months to assess capabilities and interests of persons with dementia, home environments, and caregiver knowledge, and readiness from which activities are developed and families trained in their use. Families learn to modify activities for future declines and use strategies to address care challenges. The comparison group controls for time and attention and involves 8 in-home sessions delivered by health educators who provide dementia education, home safety recommendations, and advanced care planning. We are randomizing 250 racially diverse families (person with dementia and primary caregiver dyads) recruited from community-based social services, conferences and media announcements. The primary outcome is change in agitation/aggression at 3 and 6months. Secondary outcomes assess quality of life of persons with dementia, other behaviors, burden and confidence of caregivers, and cost and cost effectiveness. If benefits are supported, this activity intervention will provide a clinically meaningful approach to prevent, reduce, and manage NPS.
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA. Electronic address: lgitlin1@jhu.edu.
authors.forename: Laura N
authors.initials: LN
authors.lastname: Gitlin
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Catherine Verrier
authors.initials: CV
authors.lastname: Piersol
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Hodgson
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Katherine
authors.initials: K
authors.lastname: Marx
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Roth
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Deidre
authors.initials: D
authors.lastname: Johnston
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Quincy
authors.initials: Q
authors.lastname: Samus
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Pizzi
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Jutkowitz
authors.affiliation: Center for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Constantine G
authors.initials: CG
authors.lastname: Lyketsos
mesh_terms: D000374:Aggression / Q000523:psychology; D001288:Attention; D017028:Caregivers; D003704:Dementia / Q000451:nursing / Q000523:psychology / Q000534:rehabilitation*; D006792:House Calls; D006801:Humans; D009788:Occupational Therapy / Q000379:methods*; D000066553:Problem Behavior / Q000523:psychology; D011595:Psychomotor Agitation / Q000523:psychology
keywords: Activities; Dementia; Family caregiving; Neuropsychological behaviors; Occupational therapy; Psychosocial intervention