Delirium in Persons With Dementia

January 11, 2018 updated by: Donna Fick, Penn State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Mount Nittany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Persons with Dementia
Persons with Dementia are identified by the Modified Blessed Dementia Rating Scale and the IQCODE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Participants will be assessed daily until discharge (duration of hospitalization), which is expected to be about 5 days
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.
Participants will be assessed 1 month after date of hospital discharge
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.
Participants will be assessed 3 months after date of hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization Length of Stay
Time Frame: Duration of hospitalization, expected to be about 5 days
Duration of hospitalization, expected to be about 5 days
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
Daily until discharge, expected to be about 5 days
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
Participant will be assessed 1 month after date of hospital discharge
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
Participant will be assessed 3 months after date of hospital discharge
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
Daily until discharge, expected to be about 5 days
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
Participant will be assessed 1 month after date of hospital discharge
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
Participant will be assessed 3 months after date of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Augusta University
Indiana University
Harvard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna Fick, PhD, Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R03AG023216-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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