Evidence map›Paper›PMID 27339865›Full record

Trial reportContemporary clinical trials2016

Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial.

Laura N Gitlin, Catherine Verrier Piersol, Nancy Hodgson, Katherine Marx, David L Roth, Deidre Johnston, Quincy Samus, Laura Pizzi, Eric Jutkowitz, Constantine G Lyketsos

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03682185 (The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia), which is not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03682185 phase3completednot on this map

The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study

TypeinterventionalSponsorUniversity of PennsylvaniaRan2016 to 2021Enrolled421ConditionsDementia, Alzheimer Disease, Circadian Rhythm Disorders, Circadian Rhythm Sleep DisorderArmsAttention-Control Condition, Timed Activity Intervention
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Article
  12. Understanding the Role of Neuropsychiatric Symptoms in Functional Decline in Alzheimer's Disease.The Journal of neuropsychiatry and clinical neurosciences · 2026
    Article
  13. Improving quality measurement for dementia care.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Laura N GitlinCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA. Electronic address: lgitlin1@jhu.edu.
Catherine Verrier PiersolCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Nancy HodgsonCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Katherine MarxCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
David L RothCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Deidre JohnstonCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Quincy SamusCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Laura PizziCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Eric JutkowitzCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.
Constantine G LyketsosCenter for Innovative Care in Aging, Johns Hopkins University, Baltimore, MD, USA.

Funding

'T V ASSESSMENT - MEMORY DISORDERED PATIENTS'P50AG005146 · NIA · JOHNS HOPKINS UNIVERSITY · PI BANDEEN-ROCHE, KAREN J. · 1985 to 2019
$37.6M
Reducing Agitation in Dementia Patients at Home: The Customized Activity TrialR01AG041781 · NIA · JOHNS HOPKINS UNIVERSITY · PI GITLIN, LAURA N. · 2012 to 2017
$3.3M
NIA NIH HHS P50 AG005146NIA NIH HHS R01 AG041781
6 · The paper itself

Abstract

Among over 5million people in the USA with dementia, neuropsychiatric symptoms (NPS) are almost universal, occurring across disease etiology and stage. If untreated, NPS can lead to significant morbidity and mortality including increased cost, distress, depression, and faster disease progression, as well as heightened burden on families. With few pharmacological solutions, identifying nonpharmacologic strategies is critical. We describe a randomized clinical trial, the Dementia Behavior Study, to test the efficacy of an activity program to reduce significant existing NPS and associated caregiver burden at 3 and 6months compared to a control group intervention. Occupational therapists deliver 8 in-home sessions over 3months to assess capabilities and interests of persons with dementia, home environments, and caregiver knowledge, and readiness from which activities are developed and families trained in their use. Families learn to modify activities for future declines and use strategies to address care challenges. The comparison group controls for time and attention and involves 8 in-home sessions delivered by health educators who provide dementia education, home safety recommendations, and advanced care planning. We are randomizing 250 racially diverse families (person with dementia and primary caregiver dyads) recruited from community-based social services, conferences and media announcements. The primary outcome is change in agitation/aggression at 3 and 6months. Secondary outcomes assess quality of life of persons with dementia, other behaviors, burden and confidence of caregivers, and cost and cost effectiveness. If benefits are supported, this activity intervention will provide a clinically meaningful approach to prevent, reduce, and manage NPS.

Indexed as

CaregiversHouse CallsAggressionAttentionDementiaHumansOccupational TherapyProblem BehaviorPsychomotor AgitationActivitiesDementiaFamily caregivingNeuropsychological behaviorsOccupational therapyPsychosocial intervention

Identifiers

PMID27339865
PMCPMC4969112

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.