Reducing Agitation in People With Dementia: the Customized Activity Trial

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 23, 2017

Study Completion Date

November 23, 2017

Conditions
Dementia
Interventions
BEHAVIORAL

Tailored Activity Program

TAP is designed to tap into spared or residual abilities and provide an environment supportive of these abilities. Activities are selected that build on preserved capabilities, long-term interests and procedural memory, but which do not tax areas of cognition that are most impaired (e.g., memory, new learning). Activities selected are simplified (1 to 2 vs multiple, complex steps), thereby minimizing errors. The activity environment is set up to provide auditory or tactile cues to facilitate recall and guide initiation and sequencing. By grading activities to match PwD capabilities, the interventionist minimizes demand that may heighten stress (e.g., high functioning individuals are introduced to more goal-directed, multi-step activities, whereas lower functioning individuals are introduced to activities involving repetitive motion (e.g., washing windows, folding towels, placing materials in a bin) and integrate multi-sensory stimulation (e.g., soft music, objects pleasant to touch).

OTHER

Home Safety and Education Program

The control group intervention is designed to control for the nonspecific elements of TAP such as social engagement with PwD and CG which may affect outcomes. It is a fully-structured, nondirective, supportive education approach that conveys empathy, respect and specific disease education elements of which have been tested in other trials. Unlike TAP, this group contains no active elements beyond its nonspecific components, has no long-lasting treatment effects, and no theoretical basis to support an effect on agitation. It is delivered by a trained research team member who uses active listening, open questioning, reflecting back, and summation with CGs.

Trial Locations (1)

21205

Johns Hopkins University School of Nursing, Center for Innovative Care in Aging, Baltimore

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Johns Hopkins University

OTHER

NCT01892579 - Reducing Agitation in People With Dementia: the Customized Activity Trial | Biotech Hunter | Biotech Hunter