Reducing Agitation in People With Dementia: the Customized Activity Trial (TAP)
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Tailored Activity Program. We will test the program using a randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to received a program of tailored activities or a control intervention of equivalent in-home attention and social contact. The trial assesses PwDs' preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. Our primary study aim evaluates the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity program will have less frequent agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower severity scores at 6 months and better quality of life compared to PwD in the control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring activities will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost effective compared to the control intervention at each test occasion). Exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored activity program will use activities at 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, the Tailored Activity Program has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity.
Behavioral: Tailored Activity Program
Other: Home Safety and Education Program
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Reducing Agitation in People With Dementia: the Customized Activity Trial|
- Frequency of Agitated Behavior in person with dementia [ Time Frame: 3 months ] [ Designated as safety issue: No ]Frequency of agitated behaviors is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver.
- Frequency of agitated behaviors and quality of life in person with dementia [ Time Frame: 6 months ] [ Designated as safety issue: No ]Frequency of agitated behaviors is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver.
- Caregiver wellbeing and time spent providing care [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]Caregiver wellbeing will be measured with a burden scale and confidence using activities. Time spent providing care will be measured with a vigilance scale and the RUD 3.0 supplemented with the SURFS and Health Utility Index.
- Cost effectiveness [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]Cost effectiveness will be measured by tracking intervention costs, hospital stays, use of services, time to nursing home or death, medications and caregiver costs. Cost will also be measured by quality of life measures (EuroQol-5D).
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892579
|Contact: Katherine Marx, PhDfirstname.lastname@example.org|
|Contact: Katherine A Marx, Ph.Demail@example.com|
|United States, Maryland|
|Johns Hopkins University School of Nursing, Center for Innovative Care in Aging||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Katherine A Marx, PhD, MPH 443-287-4595 firstname.lastname@example.org|
|Principal Investigator: Laura N Gitlin, Ph.D|
|Sub-Investigator: Constantine G Lyketsos, MD, MHS|
|Sub-Investigator: Quincy M Samus, Ph.D|
|Sub-Investigator: Nancy Hodgson, Ph.D, RN|
|Sub-Investigator: David Roth, Ph.D|
|Sub-Investigator: Deirdre Johnston, MB, BCh, MRCPsych|
|Principal Investigator:||Laura N Gitlin, Ph.D||Johns Hopkins University|