Delirium Superimposed on DementiaNCT01394328
Delirium in Persons With Dementia
An observational study of Delirium Superimposed on Dementia, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium Superimposed on Dementia
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 165 hospitalized older adults at Mount Nittany Medical Center, age 65 and older with Dementia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Nittany Medical Center
State College, Pennsylvania, 16801
About this study
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.
Read the 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.
- Conditions
- Delirium Superimposed on Dementia
- Keywords
- Delirium, Dementia, Confusion Assessment Method, Elderly
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons with Dementia | Persons with Dementia are identified by the Modified Blessed Dementia Rating Scale and the IQCODE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delirium status during hospital stay
Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.
Measured: 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
Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.
Measured: Participants will be assessed 1 month after date of hospital discharge
Change in Delirium status at 3 months after discharge
Confusion Assessment Method (CAM)and Delirium Rating Scale (DRS) were used to measure delirium.
Measured: Participants will be assessed 3 months after date of hospital discharge
Secondary outcomes (7)
Hospitalization Length of Stay
Measured: Duration of hospitalization, expected to be about 5 days
Change in Functional Status during hospital stay
Measured using the KATZ ADL Scale and Lawton Index of Daily Living
Measured: Daily until discharge, expected to be about 5 days
Change in Functional Status at 1 month after discharge
Measured using the KATZ ADL Scale and Lawton Index of Daily Living
Measured: Participant will be assessed 1 month after date of hospital discharge
Change in Functional Status at 3 months after discharge
Measured using the KATZ ADL Scale and Lawton Index of Daily Living
Measured: Participant will be assessed 3 months after date of hospital discharge
Change in Cognitive Decline during hospital stay
MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Measured: Daily until discharge, expected to be about 5 days
Change in Cognitive Decline at 1 month after discharge
MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Measured: Participant will be assessed 1 month after date of hospital discharge
Change in Cognitive Decline at 3 months after discharge
MMSE and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) used to measure cognition
Measured: Participant will be assessed 3 months after date of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startApr 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium Superimposed on DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, Harvard University, Indiana University
- Responsible party
- Principal investigator, Donna Fick, Penn State University
- Investigators
- Donna Fick, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394328
- Sponsor's protocol ID
- 1R03AG023216-01A1
- Status last verified
- Jan 2018
- First submitted
- 11 Jul 2011
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in Persons With Dementia
- ClinicalTrials.gov ID
- NCT01394328
- Acronym / sponsor ID
- 1R03AG023216-01A1
- Conditions
- Delirium Superimposed on Dementia
- Keywords
- Delirium, Dementia, Confusion Assessment Method, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Augusta University, Harvard University, Indiana University
- Study start
- Apr 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Dementia | – | –Persons with Dementia are identified by the Modified Blessed Dementia Rating Scale and the IQCODE |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 165 hospitalized older adults at Mount Nittany Medical Center, age 65 and older with Dementia.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
7 secondary outcomes
Hospitalization Length of Stay
Time frame: 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
Change in Functional Status at 1 month after discharge
Time frame: 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
Change in Cognitive Decline during hospital stay
Time frame: 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
Change in Cognitive Decline at 3 months after discharge
Time frame: Participant will be assessed 3 months after date of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Related trials for Delirium Superimposed on Dementia
Recruiting
Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation
Delirium, Delirium in Old Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Fick, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium Superimposed on Dementia, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.