DeliriumNCT03317106
the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
An observational study of Delirium and Cerebral Infarction, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium, Cerebral Infarction
- How many people
- 943 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Aug 2017to 31 Aug 2018
- How long will I take part?
- 3 Weeks
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.
Who may be able to join
- All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.
Who cannot join
- Any patients who refuse to enroll the study.
- Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Munhwa-ro 282, Jung-gu
About this study
Official title: the Prospective Study on the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.
- Conditions
- Delirium, Cerebral Infarction
- Medical subject headings
- Delirium, Cerebral Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
mean K-DRS-R98 score
mean score of delirium severity rating scale during follow up period. Detailed information about scale: Korean Version of the Delirium Rating Scale-Revised-98(K-DRS-R98) DRS-R98 proved to be a valid and reliable instrument for the assessment of delirium severity and distinguish patients with delirium from non-delirious patients including dementia. The scale is composed of two sections. The first section is the severity scale, which consists of 13 items that are scored from 0 to 3 according to a Likert scale that is anchored by descriptions of phe-nomenology. The second section consists of three diagnostic items that are scored from 0 to 2 or 3. These items include temporal onset of symptoms, fluctuation of symptom severity and physical disorder. The total scale is comprised of 16 items. The total score is the sum of the scores for each item and the higher the score, the greater the severity.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start8 Aug 2017
- Primary completion31 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- 943 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heewon Yang, Chungnam National University Hospital
- Investigators
- Jeonglan Kim, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317106
- Sponsor's protocol ID
- 2017-07-058
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Prospective Study on the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT03317106
- Acronym / sponsor ID
- 2017-07-058
- Conditions
- Delirium, Cerebral Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.
Key inclusion criteria (1 listed)
- All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.
Key exclusion criteria (2 listed)
- Any patients who refuse to enroll the study.
- Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.
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
mean K-DRS-R98 score
Time frame: 3 weeks
mean score of delirium severity rating scale during follow up period. Detailed information about scale: Korean Version of the Delirium Rating Scale-Revised-98(K-DRS-R98) DRS-R98 proved to be a valid and reliable instrument for the assessment of delirium severity and distinguish patients with delirium from non-delirious patients including dementia. The scale is composed of two sections. The first section is the severity scale, which consists of 13 items that are scored from 0 to 3 according to a Likert scale that is anchored by descriptions of phe-nomenology. The second section consists of three diagnostic items that are scored from 0 to 2 or 3. These items include temporal onset of symptoms, fluctuation of symptom severity and physical disorder. The total scale is comprised of 16 items. The total score is the sum of the scores for each item and the higher the score, the greater the severity.
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 28 Jul 2021.
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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.
Jeonglan Kim study chair
Professor
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 and Cerebral Infarction, run by Chungnam National University Hospital at 1 site in South Korea.
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 2 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 28 Jul 2021. 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 South Korea. 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?
mean K-DRS-R98 score (time frame: 3 weeks). 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 28 Jul 2021.