Clinical trial NCT01394328: Delirium in Persons With Dementia
Official title: Delirium in Persons With Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium Superimposed on Dementia
Keywords: Delirium
Dementia
Confusion Assessment Method
Elderly
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Augusta University
name: Harvard University
name: Indiana University
First posted: 2011-07-14
Enrollment: 308
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 165 hospitalized older adults at Mount Nittany Medical Center, age 65 and older with Dementia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Delirium status during hospital stay
timeFrame: Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
measure: Change in Delirium status at 1 month after discharge
timeFrame: Participants will be assessed 1 month after date of hospital discharge
measure: Change in Delirium status at 3 months after discharge
timeFrame: Participants will be assessed 3 months after date of hospital discharge
Secondary outcomes:
measure: Hospitalization Length of Stay
timeFrame: Duration of hospitalization, expected to be about 5 days
measure: Change in Functional Status during hospital stay
timeFrame: Daily until discharge, expected to be about 5 days
measure: Change in Functional Status at 1 month after discharge
timeFrame: Participant will be assessed 1 month after date of hospital discharge
measure: Change in Functional Status at 3 months after discharge
timeFrame: Participant will be assessed 3 months after date of hospital discharge
measure: Change in Cognitive Decline during hospital stay
timeFrame: Daily until discharge, expected to be about 5 days
measure: Change in Cognitive Decline at 1 month after discharge
timeFrame: Participant will be assessed 1 month after date of hospital discharge
measure: Change in Cognitive Decline at 3 months after discharge
timeFrame: Participant will be assessed 3 months after date of hospital discharge
Other outcomes:
Locations:
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Donna Fick, PhD
role: PRINCIPAL_INVESTIGATOR
References: