Skip to main content
OpenTrials
Completed

NCT Number: NCT01394328

Delirium in Persons With Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Nittany Medical Center

State College, Pennsylvania, 16801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Delirium status during hospital stay

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

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

  2. Change in Delirium status at 1 month after discharge

    Time frame: Participants will be assessed 1 month after date of hospital discharge

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

  3. Change in Delirium status at 3 months after discharge

    Time frame: Participants will be assessed 3 months after date of hospital discharge

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

Secondary outcomes

  1. Hospitalization Length of Stay

    Time frame: Duration of hospitalization, expected to be about 5 days

  2. Change in Functional Status during hospital stay

    Time frame: Daily until discharge, expected to be about 5 days

    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  3. Change in Functional Status at 1 month after discharge

    Time frame: Participant will be assessed 1 month after date of hospital discharge

    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  4. Change in Functional Status at 3 months after discharge

    Time frame: Participant will be assessed 3 months after date of hospital discharge

    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  5. Change in Cognitive Decline during hospital stay

    Time frame: Daily until discharge, expected to be about 5 days

    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition

  6. Change in Cognitive Decline at 1 month after discharge

    Time frame: Participant will be assessed 1 month after date of hospital discharge

    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition

  7. Change in Cognitive Decline at 3 months after discharge

    Time frame: Participant will be assessed 3 months after date of hospital discharge

    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Augusta University
  • Harvard University
  • Indiana University

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 14, 2011
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.