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Delirium in Persons With Dementia

Delirium in Persons With Dementia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01394328
Enrollment
308
Registered
2011-07-14
Start date
2006-04-30
Completion date
2008-11-30
Last updated
2018-01-16

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

Conditions

Delirium Superimposed on Dementia

Keywords

Delirium, Dementia, Confusion Assessment Method, Elderly

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.

Detailed 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.

Interventions

None listed

Sponsors

Augusta University
CollaboratorOTHER
Harvard University
CollaboratorOTHER
Indiana University
CollaboratorOTHER
Penn State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Delirium status at 3 months after dischargeParticipants will be assessed 3 months after date of hospital dischargeConfusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.
Change in Delirium status during hospital stayParticipants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 daysConfusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.
Change in Delirium status at 1 month after dischargeParticipants will be assessed 1 month after date of hospital dischargeConfusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

Secondary

MeasureTime frameDescription
Change in Functional Status at 3 months after dischargeParticipant will be assessed 3 months after date of hospital dischargeMeasured using the KATZ ADL Scale and Lawton Index of Daily Living
Change in Cognitive Decline during hospital stayDaily until discharge, expected to be about 5 daysMMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Hospitalization Length of StayDuration of hospitalization, expected to be about 5 days
Change in Cognitive Decline at 3 months after dischargeParticipant will be assessed 3 months after date of hospital dischargeMMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Change in Cognitive Decline at 1 month after dischargeParticipant will be assessed 1 month after date of hospital dischargeMMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Change in Functional Status during hospital stayDaily until discharge, expected to be about 5 daysMeasured using the KATZ ADL Scale and Lawton Index of Daily Living
Change in Functional Status at 1 month after dischargeParticipant will be assessed 1 month after date of hospital dischargeMeasured using the KATZ ADL Scale and Lawton Index of Daily Living

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026