Cognitive Intervention For Delirium in Dementia

Phase 2

Completed

• Conditions: Dementia; Delirium
• Interventions: Behavioral: Cognitive Stimulation

• Registration Number: NCT01267682
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Study Start: 2011-01
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Cognitive Stimulation	Behavioral: cognitive stimulation

Primary Outcome Measures

Name	Time	Method
Confusion Assessment Method	Averaged over 30 days or until discharge, whichever comes first
Delirium Rating Scale	Averaged over 30 days or until discharge, whichever comes first

Secondary Outcome Measures

Name	Time	Method
Executive Function	Averaged over 30 days or until discharge, whichever comes first
Physical Function	Averaged over 30 days or until discharge, whichever comes first
Attention	Averaged over 30 days or until discharge, whichever comes first
Memory	Averaged over 30 days or until discharge, whichever comes first
Abstract Thinking	Averaged over 30 days or until discharge, whichever comes first
Orientation	Averaged over 30 days or until discharge, whichever comes first

Trial Locations

Locations (9)

Centre Crest Nursing Home; 🇺🇸 Bellefonte, Pennsylvania, United States

Spring Creek Rehabilitation and Nursing Center; 🇺🇸 Harrisburg, Pennsylvania, United States

The Meadows Manor; 🇺🇸 Dallas, Pennsylvania, United States

Windy Hill Village; 🇺🇸 Philipsburg, Pennsylvania, United States

Mountain View; 🇺🇸 Scranton, Pennsylvania, United States

Brookline Nursing & Rehabilitation Center; 🇺🇸 State College, Pennsylvania, United States

Hearthside Nursing Home; 🇺🇸 State College, Pennsylvania, United States

The Village at Penn State; 🇺🇸 State College, Pennsylvania, United States

Hearthside Nursing and Rehabilitation Center; 🇺🇸 State College, Pennsylvania, United States