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Randomized Controlled Trial
. 2016 Jul:49:92-102.
doi: 10.1016/j.cct.2016.06.006. Epub 2016 Jun 21.

Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial

Laura N Gitlin  1 , Catherine Verrier Piersol  2 , Nancy Hodgson  2 , Katherine Marx  2 , David L Roth  2 , Deidre Johnston  2 , Quincy Samus  2 , Laura Pizzi  2 , Eric Jutkowitz  2 , Constantine G Lyketsos  2
Affiliations
Randomized Controlled Trial

Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial

Laura N Gitlin et al. Contemp Clin Trials. 2016 Jul.

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.

Trial registration: ClinicalTrials.gov NCT01892579.

Keywords: Activities; Dementia; Family caregiving; Neuropsychological behaviors; Occupational therapy; Psychosocial intervention.

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Figures

Figure 1
Figure 1
Flowchart of Study Design
Figure 2
Figure 2
Conceptual Model Linking Neurodegenerative Changes with Decreased Engagement and Behavioral Symptoms
Figure 3
Figure 3
Decision-matrix for Identifying and Tailoring Activities
See this image and copyright information in PMC

References

    1. Alzheimer's Association . 216 Alzheimer's Disease Facts and Figures. 4. Vol. 12. Alzheimer's & Dementia; 2016. - PubMed
    1. Bang H, Zhao H. Median-based incremental cost-effectiveness ratio (ICER). Journal of Statistical Theory and Practice. 2012;6(3):428–442. doi:10.1080/15598608.2012.695571 [doi] - PMC - PubMed
    1. Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: A new short version and screening version. The Gerontologist. 2001;41:652–657. - PubMed
    1. Beeri MS, Werner P, Davidson M, Noy S. The cost of behavioral and psychological symptoms of dementia (BPSD) in community dwelling Alzheimer's disease patients. International Journal of Geriatric Psychiatry. 2002;17(5):403–408. doi:10.1002/gps.490 [doi] - PubMed
    1. Brazier JE, Harper R, Jones NMB, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305:160–4. - PMC - PubMed

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