Reducing Agitation in People With Dementia: the Customized Activity Trial (TAP)
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|ClinicalTrials.gov Identifier: NCT01892579|
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Behavioral: Tailored Activity Program Other: Home Safety and Education Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Reducing Agitation in People With Dementia: the Customized Activity Trial|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 23, 2017|
|Actual Study Completion Date :||November 23, 2017|
Experimental: Tailored Activity Program
The Tailored Activity Program unfolds over 3 phases: Phase I (sessions 1-2) involves assessment of Person with Dementia (PwD)capacity and interests, caregiver (CG) interactions and the physical environment and CG education. Phase II (sessions 3-6) involves identifying and implementing 3 "Activity Prescriptions" tailored to PwD's cognitive and interest profile using an algorithmic guide. The prescription summarizes PwD capabilities in lay language, identifies the activity and a specific activity goal, and provides specific instructions for introducing the activity. CGs are trained to integrate activities in daily care. Also provided are simple deep breathing stress reduction techniques to address CG upset. Phase III (sessions 7-8) involves instructing CGs in simplifying activities for future cognitive declines and applying simplification principles to other care challenges.
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).
Active Comparator: Home Safety and Education Program
This arm receives 6 in-home and 2 brief telephone education sessions. Each contact is structured to provide helpful education. Sessions include information on home safety, fall risk assessment, talking to your doctor, advanced planning, identifying resources, and caring for the caregiver (CG). Each session is prescriptive and designed to maximize attention; yet, sessions will not involve any component of the intervention group. To engage the person with dementia (PwD), the interventionist will socially engage the person briefly in select sessions. Time spent with CG and PwD in the control group is comparable to that for intervention dyads.
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.
- Frequency by severity of Agitated and Aggressive Behavior in person with dementia [ Time Frame: 3 months ]Frequency by severity of agitated and aggressive behaviors measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver. Frequency for severity for both is calculated and then the numbers are added together.
- Frequency of behavioral symptoms in person with dementia [ Time Frame: 6 months ]Frequency of agitated behaviors is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver.
- Quality of life in person with dementia rated by caregiver [ Time Frame: 3 and 6 months ]Quality of life is measured with the Perceived Change for the Better Index as rated by the caregiver.
- Quality of life in person with dementia rated by person with dementia [ Time Frame: 3 and 6 months ]Quality of life is measured with the Quality of Life index completed by the person with dementia.
- Caregiver wellbeing [ Time Frame: 3 and 6 months ]Caregiver wellbeing will be measured with the Zarit burden scale.
- Time spent caregiving [ Time Frame: 3 and 6 months ]Time spent providing care will be measured with the RUD 3.0 supplemented with the SURFS and Health Utility Index.
- Cost effectiveness by intervention cost [ Time Frame: 3 and 6 months ]Cost effectiveness by intervention cost will be calculated from interventionist payroll and mileage, also by cost of supplies for intervention
- Cost effectiveness by medical costs [ Time Frame: 3 and 6 months ]Cost effectiveness will be measured by hospital stays, use of services, time to nursing home or death, medications and caregiver costs.
- Cost effectiveness by quality of life [ Time Frame: 3 and 6 months ]Cost effectiveness will be measured by quality of life measures (EuroQol-5D).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892579
|United States, Maryland|
|Johns Hopkins University School of Nursing, Center for Innovative Care in Aging|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Laura N Gitlin, Ph.D||Johns Hopkins University|