Reducing Agitation in People With Dementia: the Customized Activity Trial (TAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura N. Gitlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01892579
First received: June 27, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Dementia
Behavioral: Tailored Activity Program
Other: Home Safety and Education Program
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 250
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Other Names:
  • TAP
  • CAP
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.

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  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Inclusion criteria pertain to both the person with dementia (PwD) and the caregiver (CG) such that if either is eligible but the other is not, the dyad is not enrolled.

  • PwD and caregiver are English speaking
  • Diagnosed with probable dementia
  • PwD is able to participate in at least 2 activities of daily living (bathing, dressing, grooming, toileting, transferring from bed to chair)
  • Person with dementia exhibits agitated or aggressive behaviors
  • If PwD is on a psychotropic medication he/she must be on a stable dose for at least 60 days
  • CG is at least 21 years old
  • CG lives with or within 5 miles of the person with dementia
  • CG is accessible by telephone to schedule interviews and sessions
  • CG is planning to live in the area for at least 6 months
  • If the CG is on a psychotropic medication he/she must be on a stable dose for at least 60 days

Exclusion Criteria:Exclusion criteria pertain to both the person with dementia and the caregiver such that if either is eligible but the other is not, the dyad is not enrolled.

  • PwD has a history of schizophrenia or bipolar disorder
  • Dementia is secondary to probable head trauma
  • PwD is not responsive to environment (e.g., unable to understand short commands or recognize a person coming in/out of the room).
  • the CG is currently involved in another clinical trial of psychosocial or educational interventions
  • the CG is planning to place PwD in a nursing home within 6 months.
  • dyads will be excluded if either CG or PwD: 1) has a terminal illness with life expectancy < 6 months, 2) is in active treatment for cancer, or 3) has had > 3 acute medical hospitalizations in past year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892579

Contacts
Contact: Katherine Marx, PhD 443-287-4595 kmarx1@jhu.edu
Contact: Katherine A Marx, Ph.D 443-287-8633 kmarx1@jhu.edu

Locations
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    kmarx1@jhu.edu   
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         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Laura N Gitlin, Ph.D Johns Hopkins University
  More Information

Publications:
Responsible Party: Laura N. Gitlin, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01892579     History of Changes
Other Study ID Numbers: TAP-NIA, R01AG041781
Study First Received: June 27, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Johns Hopkins University:
Agitation
Dementia
Alzheimer's Disease
Neuropsychiatric Behaviors

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014