Delirium in Persons With Dementia

NCT01394328 | Completed

• 1 other identifier: 1R03AG023216-01A1
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were to identify risk factors associated with delirium in hospitalized persons with dementia, and to describe immediate and post-hospital (1\&3 months) trajectory of cognitive decline and associated outcomes in persons with dementia who develop delirium. It was hypothesized that factors such as CNS-active medications, urinary tract infection, stage of dementia, pain, activity level, and dehydration would be associated with an increased risk of delirium and delirium severity in patients with dementia compared to dementia patients without delirium. It was also hypothesized that persons with DSD will have worse outcomes (longer hospital length of stays, decreased functional status, a steeper negative slope of cognitive decline) than dementia patients without delirium. Lastly, it was hypothesized that higher delirium severity would be associated with poorer outcomes in persons with dementia. The long-term objectives were to use the results from this study to design and test an intervention strategy to improve early recognition, management, prevention, and outcomes in persons with DSD.

Conditions

Delirium Superimposed on Dementia

Keywords

Delirium; Dementia; Confusion Assessment Method; Elderly

Outcome Measures

Primary Outcomes (3)

• Change in Delirium status during hospital stay

  Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

  Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days

• Change in Delirium status at 1 month after discharge

  Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

  Participants will be assessed 1 month after date of hospital discharge

• Change in Delirium status at 3 months after discharge

  Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

  Participants will be assessed 3 months after date of hospital discharge

Secondary Outcomes (7)

• Hospitalization Length of Stay

  Duration of hospitalization, expected to be about 5 days

• Change in Functional Status during hospital stay

  Daily until discharge, expected to be about 5 days

• Change in Functional Status at 1 month after discharge

  Participant will be assessed 1 month after date of hospital discharge

• Change in Functional Status at 3 months after discharge

  Participant will be assessed 3 months after date of hospital discharge

• Change in Cognitive Decline during hospital stay

  Daily until discharge, expected to be about 5 days

Study Arms (1)

Persons with Dementia

Persons with Dementia are identified by the Modified Blessed Dementia Rating Scale and the IQCODE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

165 hospitalized older adults at Mount Nittany Medical Center, age 65 and older with Dementia.

You may qualify if:

• Persons with dementia were included if they: a) were on one of the selected medical-surgical units and age 65 years or older; b) spoke English; c) were hospitalized less than 24 hours; and d) met the criteria for dementia. This study included minorities and women.

You may not qualify if:

• Persons with dementia were excluded if they: a) had any significant neurological or neurosurgical disease associated with cognitive impairment other than dementia (due to confounding with dementia or DSD), such as parkinson's disease, Huntington's disease, normal pressure hydrocephalus, seizure disorder, subdural hematoma, head trauma or any other known structural brain abnormalities; b) were nonverbal and unable to communicate due to sever dementia (MMSE=0), aphasia, intubation, or terminal illness (since interviews were required for the study); or c) had no family or caregivers to interview (since proxy interviews were required for the study). This study did not exclude persons with pre-existing delirium. In addition, subjects were not excluded on the basis of race or gender.

Sponsors & Collaborators

• Penn State University: lead
• Augusta University: collaborator
• Harvard University: collaborator
• Indiana University: collaborator

Study Sites (1)

Mount Nittany Medical Center

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Delirium; Dementia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Donna Fick, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 14, 2011
• Study Start: April 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (1)