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Cognitive Intervention For Delirium in Dementia

Reserve For Delirium Superimposed On Dementia (DSD)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267682
Enrollment
283
Registered
2010-12-28
Start date
2011-01-31
Completion date
2016-03-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Dementia

Keywords

Delirium, Dementia, Non-pharmacological Intervention, Post-acute care

Brief summary

The purpose of this study is to test the effectiveness of cognitively stimulating activities for resolving delirium in people with dementia.

Detailed description

The primary aim in this RCT is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD). The investigators will randomize 256 subjects, newly admitted to post acute care, to intervention (RESERVE-DSD) or control (usual care). Intervention subjects will receive 30-minute sessions of tailored cognitively stimulating recreational activities for up to 30 days. The investigators hypothesize that subjects who receive RESERVE-DSD will have: decreased severity and duration of delirium; greater gains in attention, orientation, memory, abstract thinking, and executive functioning; and greater gains in physical function compared to subjects with DSD who receive usual care. The investigators will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). The secondary aim is to describe the costs associated with RESERVE-DSD.

Interventions

BEHAVIORALCognitive Stimulation

Thirty minutes of cognitive stimulation delivered daily for thirty minutes.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* presence of delirium * mild to moderate cognitive impairments * 65 years of age or older * English speaking * community-dwelling * legally authorized representative available

Exclusion criteria

* severe vision or hearing problems * diagnosis of 1. major depression 2. Parkinson's with Lewy Body disease 3. Huntington's disease 4. normal pressure hydrocephalus 5. seizure disorder 6. subdural hematoma 7. head trauma 8. known structural brain abnormalities 9. acute CVA/stroke 10. acute psychiatric condition * life expectancy \< 6 months

Design outcomes

Primary

MeasureTime frame
Confusion Assessment MethodAveraged over 30 days or until discharge, whichever comes first
Delirium Rating ScaleAveraged over 30 days or until discharge, whichever comes first

Secondary

MeasureTime frame
Abstract ThinkingAveraged over 30 days or until discharge, whichever comes first
OrientationAveraged over 30 days or until discharge, whichever comes first
AttentionAveraged over 30 days or until discharge, whichever comes first
Physical FunctionAveraged over 30 days or until discharge, whichever comes first
Executive FunctionAveraged over 30 days or until discharge, whichever comes first
MemoryAveraged over 30 days or until discharge, whichever comes first

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026