Delirium in Persons With Dementia

Delirium Superimposed on Dementia Clinical Trial

Official title:

Delirium in Persons With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394328
• Other study ID #: 1R03AG023216-01A1
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: January 11, 2018
• Start date: April 2006
• Est. completion date: November 2008

Study information

• Verified date: January 2018
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

It is well known that persons with dementia are at increased risk of developing delirium or acute confusional state. Further, current evidence suggests that delirium may worsen the prognosis of dementia, may alter the clinical course and trajectory of cognitive decline, and may be associated with substantially worse long-term outcomes. This study was a prospective cohort study design involving 165 hospitalized subjects with dementia who were 65 and older and included a three month follow up period. Aims for the study included: 1) to identify risk factors for DSD, and 2) to describe post-hospital outcomes and the trajectory of cognitive decline for DSD, which will justify the development of appropriate preventative and management strategies for delirium in patients with dementia. Delirium was assessed daily from admission to discharge and then at one and three month follow-ups. The potential risk factors being examined were 1) polypharmacy (central nervous system-active medications, number of medications, new medications added), 2) physical stressors (urinary tract infection, pain, dehydration), and 3) environmental stressors (bedrest, restraints, room changes). Outcomes were assessed by research study staff blinded to the study aims.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Delirium
• Delirium Superimposed on Dementia
• Dementia

Locations

Country	Name	City	State
United States	Mount Nittany Medical Center	State College	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	Augusta University, Harvard University, Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hospitalization Length of Stay		Duration of hospitalization, expected to be about 5 days
Secondary	Change in Functional Status during hospital stay	Measured using the KATZ ADL Scale and Lawton Index of Daily Living	Daily until discharge, expected to be about 5 days
Secondary	Change in Functional Status at 1 month after discharge	Measured using the KATZ ADL Scale and Lawton Index of Daily Living	Participant will be assessed 1 month after date of hospital discharge
Secondary	Change in Functional Status at 3 months after discharge	Measured using the KATZ ADL Scale and Lawton Index of Daily Living	Participant will be assessed 3 months after date of hospital discharge
Secondary	Change in Cognitive Decline during hospital stay	MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition	Daily until discharge, expected to be about 5 days
Secondary	Change in Cognitive Decline at 1 month after discharge	MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition	Participant will be assessed 1 month after date of hospital discharge
Secondary	Change in Cognitive Decline at 3 months after discharge	MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition	Participant will be assessed 3 months after date of hospital discharge