Reducing Agitation in People With Dementia: the Customized Activity Trial

NCT01892579 | Completed DMC

• 2 other identifiers: NA_00067873R01AG041781
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia

Keywords

Agitation; Dementia; Alzheimer's Disease; Neuropsychiatric Behaviors

Outcome Measures

Primary Outcomes (1)

• Frequency by severity of Agitated and Aggressive Behavior in person with dementia

  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.

  3 months

Secondary Outcomes (8)

• Frequency of behavioral symptoms in person with dementia

  6 months

• Quality of life in person with dementia rated by caregiver

  3 and 6 months

• Quality of life in person with dementia rated by person with dementia

  3 and 6 months

• Caregiver wellbeing

  3 and 6 months

• Time spent caregiving

  3 and 6 months

Study Arms (2)

Tailored Activity Program

EXPERIMENTAL

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

Home Safety and Education Program

ACTIVE COMPARATOR

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

Interventions

Tailored Activity Program BEHAVIORAL

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).

Also known as: TAP, CAP

Tailored Activity Program

Home Safety and Education Program OTHER

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.

Home Safety and Education Program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

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

Baltimore, Maryland, 21205, United States

Location

Related Publications (9)

• Gitlin LN, Hodgson N, Jutkowitz E, Pizzi L. The cost-effectiveness of a nonpharmacologic intervention for individuals with dementia and family caregivers: the tailored activity program. Am J Geriatr Psychiatry. 2010 Jun;18(6):510-9. doi: 10.1097/JGP.0b013e3181c37d13.

  PMID: 20847903 BACKGROUND

• Jutkowitz E, Gitlin LN, Pizzi LT. Evaluating willingness-to-pay thresholds for dementia caregiving interventions: application to the tailored activity program. Value Health. 2010 Sep-Oct;13(6):720-5. doi: 10.1111/j.1524-4733.2010.00739.x. Epub 2010 Jun 7.

  PMID: 20561331 BACKGROUND

• Gitlin LN, Winter L, Vause Earland T, Adel Herge E, Chernett NL, Piersol CV, Burke JP. The Tailored Activity Program to reduce behavioral symptoms in individuals with dementia: feasibility, acceptability, and replication potential. Gerontologist. 2009 Jun;49(3):428-39. doi: 10.1093/geront/gnp087. Epub 2009 May 6.

  PMID: 19420314 BACKGROUND

• Gitlin LN, Winter L, Burke J, Chernett N, Dennis MP, Hauck WW. Tailored activities to manage neuropsychiatric behaviors in persons with dementia and reduce caregiver burden: a randomized pilot study. Am J Geriatr Psychiatry. 2008 Mar;16(3):229-39. doi: 10.1097/JGP.0b013e318160da72.

  PMID: 18310553 BACKGROUND

• Gitlin LN, Roth DL, Marx K. Impact of the Tailored Activity Program (TAP) on Depressive Symptoms Among White and Black Dementia Caregivers. J Am Geriatr Soc. 2025 Oct;73(10):3208-3214. doi: 10.1111/jgs.70020. Epub 2025 Jul 28.

  PMID: 41139689 DERIVED

• Gitlin LN, Marx K, Piersol CV, Hodgson NA, Huang J, Roth DL, Lyketsos C. Effects of the tailored activity program (TAP) on dementia-related symptoms, health events and caregiver wellbeing: a randomized controlled trial. BMC Geriatr. 2021 Oct 20;21(1):581. doi: 10.1186/s12877-021-02511-4.

  PMID: 34670502 DERIVED

• Regier NG, Hodgson NA, Gitlin LN. Neuropsychiatric symptom profiles of community-dwelling persons living with dementia: Factor structures revisited. Int J Geriatr Psychiatry. 2020 Sep;35(9):1009-1020. doi: 10.1002/gps.5323. Epub 2020 May 26.

  PMID: 32363605 DERIVED

• Jutkowitz E, Scerpella D, Pizzi LT, Marx K, Samus Q, Piersol CV, Gitlin LN. Dementia Family Caregivers' Willingness to Pay for an In-home Program to Reduce Behavioral Symptoms and Caregiver Stress. Pharmacoeconomics. 2019 Apr;37(4):563-572. doi: 10.1007/s40273-019-00785-6.

  PMID: 30877638 DERIVED

• Gitlin LN, Piersol CV, Hodgson N, Marx K, Roth DL, Johnston D, Samus Q, Pizzi L, Jutkowitz E, Lyketsos CG. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016 Jul;49:92-102. doi: 10.1016/j.cct.2016.06.006. Epub 2016 Jun 21.

  PMID: 27339865 DERIVED

MeSH Terms

Conditions

Dementia; Psychomotor Agitation; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Tauopathies; Neurodegenerative Diseases

Study Officials

• Laura N Gitlin, Ph.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 4, 2013
• Study Start: November 1, 2013
• Primary Completion: August 23, 2017
• Study Completion: November 23, 2017
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)