- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040843
Documentation of Altered Mental Status
Study Overview
Status
Conditions
Detailed Description
Basically, consciousness is the state of full awareness of the self and one's relationship to the environment. There are 2 related areas of neurologic function that are connected to consciousness: content (orientation and memory) and level (arousal and response to stimuli).
The mental changes are best looked for in terms of arousal, attention, alertness, orientation, cognition, memory, affect, and perception. Arousal (level of consciousness) can be detected by the Richmond Agitation and Sedation Scale. Others are related to content of consciousness and can be evaluated by cognitive tests. After one month pilot study, the investigators chose 5 features of content of consciousness due to easy applicable and detectable;
- Attention (counting numbers backwards from 20) (>1 error positive)
- Cognition (disorganized thinking; meaningless speech, irrelevant explanations)
- Perception (visual or auditory hallucinations)
- Memory (3 items recall) (>1 error positive)
- Orientation (day of week, month and year) (>1 error positive)
These features are also combination of six item screener test and delirium symptoms.
All elderly patients (65 aged and older) presented to the emergency department, will be assessed according to these two methods; content and level of consciousness. And also, every patient's baseline status of consciousness will be obtained from surrogates who knows the patient best. All changes from patient's baseline status will be recorded. The investigators will investigate how changes are reflected in the clinic.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nevsehir, Turkey
- Nevsehir State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All older ED patients
Exclusion Criteria:
- Unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (STE MI, severe dyspnea, etc)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of impaired level of consciousness in older ED patients
Time Frame: First 30 minute of presentation to the emergency department
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Arousal (level of consciousness) measured by the Richmond Agitation and Sedation Scale.
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First 30 minute of presentation to the emergency department
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Detection of impaired content of consciousness in older ED patients
Time Frame: First 30 minute of presentation to the emergency department
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Awareness (content of consciousness) measured by the 5 criteria list questionnaire.
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First 30 minute of presentation to the emergency department
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 1 and 3 month mortality after patient enrolled
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1 and 3 month mortality after patient enrolled
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- European Delirium Association; American Delirium Society. The DSM-5 criteria, level of arousal and delirium diagnosis: inclusiveness is safer. BMC Med. 2014 Oct 8;12:141. doi: 10.1186/s12916-014-0141-2.
- Aslaner MA, Boz M, Celik A, Ahmedali A, Eroglu S, Metin Aksu N, Eroglu SE. Etiologies and delirium rates of elderly ED patients with acutely altered mental status: a multicenter prospective study. Am J Emerg Med. 2017 Jan;35(1):71-76. doi: 10.1016/j.ajem.2016.10.004. Epub 2016 Oct 5.
- Han JH, Wilber ST. Altered mental status in older patients in the emergency department. Clin Geriatr Med. 2013 Feb;29(1):101-36. doi: 10.1016/j.cger.2012.09.005.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NevsehirPH
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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