Delirium in Persons With Dementia

This study has been completed.
Sponsor:
Collaborators:
Georgia Regents University
Harvard University
Indiana University
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01394328
First received: July 11, 2011
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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.


Condition
Delirium Superimposed on Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delirium in Persons With Dementia

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

  • Change in Delirium status at 1 month after discharge [ Time Frame: Participants will be assessed 1 month after date of hospital discharge ] [ Designated as safety issue: No ]
    Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.

  • Change in Delirium status at 3 months after discharge [ Time Frame: Participants will be assessed 3 months after date of hospital discharge ] [ Designated as safety issue: No ]
    Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.


Secondary Outcome Measures:
  • Hospitalization Length of Stay [ Time Frame: Duration of hospitalization, expected to be about 5 days ] [ Designated as safety issue: No ]
  • Change in Functional Status during hospital stay [ Time Frame: Daily until discharge, expected to be about 5 days ] [ Designated as safety issue: No ]
    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  • Change in Functional Status at 1 month after discharge [ Time Frame: Participant will be assessed 1 month after date of hospital discharge ] [ Designated as safety issue: No ]
    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  • Change in Functional Status at 3 months after discharge [ Time Frame: Participant will be assessed 3 months after date of hospital discharge ] [ Designated as safety issue: No ]
    Measured using the KATZ ADL Scale and Lawton Index of Daily Living

  • Change in Cognitive Decline during hospital stay [ Time Frame: Daily until discharge, expected to be about 5 days ] [ Designated as safety issue: No ]
    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition

  • Change in Cognitive Decline at 1 month after discharge [ Time Frame: Participant will be assessed 1 month after date of hospital discharge ] [ Designated as safety issue: No ]
    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition

  • Change in Cognitive Decline at 3 months after discharge [ Time Frame: Participant will be assessed 3 months after date of hospital discharge ] [ Designated as safety issue: No ]
    MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition


Enrollment: 308
Study Start Date: April 2006
Study Completion Date: November 2008
Groups/Cohorts
Persons with Dementia
Persons with Dementia are identified by the Modified Blessed Dementia Rating Scale and the IQCODE

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394328

Locations
United States, Pennsylvania
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16801
Sponsors and Collaborators
Penn State University
Georgia Regents University
Harvard University
Indiana University
Investigators
Principal Investigator: Donna Fick, PhD Penn State University
  More Information

No publications provided

Responsible Party: Donna Fick, PhD, RN, FGSA, FAAN, Penn State University
ClinicalTrials.gov Identifier: NCT01394328     History of Changes
Other Study ID Numbers: 1R03AG023216-01A1
Study First Received: July 11, 2011
Last Updated: July 13, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Penn State University:
Delirium
Dementia
Confusion Assessment Method
Elderly

Additional relevant MeSH terms:
Dementia
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014