Incidence of Delirium in Inpatient Elderly PatientsNCT04177589
Incidence of Delirium in Inpatient Elderly Patients
An observational study of Incidence of Delirium in Inpatient Elderly Patients, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Study: prospective cohort study Register for research topic on ClinicalTrails.gov. Convenience sampling, all patients aged 60 and older entered the geriatric department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021. Direct interview with the patient. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Incidence of Delirium in Inpatient Elderly Patients
- What is being tested?
- Incidence of Delirium in Inpatient Elderly Patients
- How many people
- 500 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Dec 2020to 15 Aug 2021
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged 60 and older entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Who may be able to join
- All patients ≥ 60 years of age agree to participate in the study.
Who cannot join
- Disturbance or other cognitive disorders at the time of assessment at admission, hospital stay not exceeding 48 hours
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Geriatrics, Gia Dinh People's Hospital
Ho Chi Minh City, 700000
About this study
Official title: Incidence of Delirium and Some Related Factors in Elderly Patients Hospitalized in Geriatrics Department, Gia Dinh Hospital.
Study: prospective cohort study Register for research topic on ClinicalTrails.gov. Convenience sampling, all patients aged 60 and older entered the geriatric department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Direct interview with the patient. Minimum time 10-15 minutes for each interview.
Read more
Evaluation at the time of admission (within the first 24 hours of admission): demographic characteristics, diagnosis at Geriatric ward, frailty, activities of daily living.
Assessment during hospital stay: identifying delirum using the CAM tool. Assessment at the time of discharge: diagnosis at discharge and the drugs used during inpatient treatment in the department.
Research objectives:
- Determine the incidence of delirium in elderly patients in general geriatric department.
- Investigate some of the important related factors that are common for delirium in elderly patients in general geriatric department.
- Determine the relationship between delirium and clinical outcomes in elderly patients in general geriatric department.
Read the detailed description
Study design: prospective cohort study. Time: From December 2020 to May 2021. Place: Department of Geriatrics, Gia Dinh People's Hospital, Ho Chi Minh City. Sample population: All patients aged 60 and older entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Sampling technique: Convenience sampling Admission criteria: All patients ≥ 60 years of age agree to participate in the study.
Exclusion criteria: Disturbance or other cognitive disorders at the time of assessment at admission, hospital stay not exceeding 48 hours
Data collection:
Data collection process:
Direct interview with the patient. Minimum time 10-15 minutes for each interview (excluding time to explain purpose, method of conducting research, time for collecting information on demographic characteristics and medical conditions).
Person doing interview: geriatric resident doctors including Dinh Pham Thi Thuy Van, Huynh Khoi Nguyen, Tran Tan Dat The interviewers will explain the research objectives and only started conducting the interview when the patient or his relative (authorized) agreed to participate in the study.
Conduct interviews:
*Evaluation at the time of admission (within the first 24 hours of admission): Patients entering the geriatric ward who agree to participate in the study will be assessed by the doctor for cognitive status, clinical characteristics and a diagnostic flow chart for Delirium
Record details about:
- Demographic characteristics: gender, age, address, occupation, family status and marital status.
- Diagnosis at the time of admission, co-morbidities (pulmonary disease, hypertension, type 2 diabetes, chronic kidney disease, osteoporosis, osteoarthritis, constipation, liver and gastrointestinal diseases, cardiovascular disease, arrhythmia, endocrine and metabolic disorders, neurological diseases, urological diseases, hematological pathologies and other diseases). Amount and type of medication being taken at home up to the time of admission. Routine tests.
- Frailty status, functional activities according to ADLs and IADLs scale, initial cognitive status according to MMSE, vision and hearing.
- Evaluation during the hospital stay:
When a patient is suspected of delirium, we evaluate it using the CAM tool to identify. After that, the patient was recorded the following characteristics: the time of onset, the clinical form (increased activity, decreased activity or mixed), current medical conditions and medications.
Record falls, transfer to other wards (if any).
*Evaluation at the time of discharge: At the time of discharge, we will record the time of hospitalization, the reason for discharge (improved condition or relative request due to serious illness) or the place of hospital transfer or in-hospital death (if any).
Record diagnosis on discharge and drugs used during inpatient treatment at the department
Data collection tools: A sheet of prepared data and medical records.
Bias control:
- Information discrepancy
- Clearly define the subjects of study.
- Choose a sample according to admission and exclusion criteria
- Selection errors
- The person doing the interview is the person who wrote the data collection sheet, so it will limit the errors in the interview process.
- The variables are clearly defined and measurable.
- Collect information in a unified form.
- Being tested
- Incidence of Delirium in Inpatient Elderly Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence of Delirium in Inpatient Elderly PatientsOther
Study design: prospective cohort study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delirium in Inpatient Elderly Patients
Incidence of Delirium in elderly patients entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City
Measured: from December 2020 to May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start15 Dec 2020 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Delirium in Inpatient Elderly PatientsStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinh Pham Thi Thuy Van, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177589
- Sponsor's protocol ID
- NTL
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Delirium and Some Related Factors in Elderly Patients Hospitalized in Geriatrics Department, Gia Dinh Hospital.
- ClinicalTrials.gov ID
- NCT04177589
- Acronym / sponsor ID
- NTL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 26 Nov 2019 (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.
Study: prospective cohort study Register for research topic on ClinicalTrails.gov. Convenience sampling, all patients aged 60 and older entered the geriatric department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Direct interview with the patient. Minimum time 10-15 minutes for each interview.
Evaluation at the time of admission (within the first 24 hours of admission): demographic characteristics, diagnosis at Geriatric ward, frailty, activities of daily living.
Assessment during hospital stay: identifying delirum using the CAM tool. Assessment at the time of discharge: diagnosis at discharge and the drugs used during inpatient treatment in the department.
Research objectives:
- Determine the incidence of delirium in elderly patients in general geriatric department.
- Investigate some of the important related factors that are common for delirium in elderly patients in general geriatric department.
- Determine the relationship between delirium and clinical outcomes in elderly patients in general geriatric department.
Detailed description
Study design: prospective cohort study. Time: From December 2020 to May 2021. Place: Department of Geriatrics, Gia Dinh People's Hospital, Ho Chi Minh City. Sample population: All patients aged 60 and older entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Sampling technique: Convenience sampling Admission criteria: All patients ≥ 60 years of age agree to participate in the study.
Exclusion criteria: Disturbance or other cognitive disorders at the time of assessment at admission, hospital stay not exceeding 48 hours
Data collection:
Data collection process:
Direct interview with the patient. Minimum time 10-15 minutes for each interview (excluding time to explain purpose, method of conducting research, time for collecting information on demographic characteristics and medical conditions).
Person doing interview: geriatric resident doctors including Dinh Pham Thi Thuy Van, Huynh Khoi Nguyen, Tran Tan Dat The interviewers will explain the research objectives and only started conducting the interview when the patient or his relative (authorized) agreed to participate in the study.
Conduct interviews:
*Evaluation at the time of admission (within the first 24 hours of admission): Patients entering the geriatric ward who agree to participate in the study will be assessed by the doctor for cognitive status, clinical characteristics and a diagnostic flow chart for Delirium
Record details about:
- Demographic characteristics: gender, age, address, occupation, family status and marital status.
- Diagnosis at the time of admission, co-morbidities (pulmonary disease, hypertension, type 2 diabetes, chronic kidney disease, osteoporosis, osteoarthritis, constipation, liver and gastrointestinal diseases, cardiovascular disease, arrhythmia, endocrine and metabolic disorders, neurological diseases, urological diseases, hematological pathologies and other diseases). Amount and type of medication being taken at home up to the time of admission. Routine tests.
- Frailty status, functional activities according to ADLs and IADLs scale, initial cognitive status according to MMSE, vision and hearing.
- Evaluation during the hospital stay:
When a patient is suspected of delirium, we evaluate it using the CAM tool to identify. After that, the patient was recorded the following characteristics: the time of onset, the clinical form (increased activity, decreased activity or mixed), current medical conditions and medications.
Record falls, transfer to other wards (if any).
*Evaluation at the time of discharge: At the time of discharge, we will record the time of hospitalization, the reason for discharge (improved condition or relative request due to serious illness) or the place of hospital transfer or in-hospital death (if any).
Record diagnosis on discharge and drugs used during inpatient treatment at the department
Data collection tools: A sheet of prepared data and medical records.
Bias control:
- Information discrepancy
- Clearly define the subjects of study.
- Choose a sample according to admission and exclusion criteria
- Selection errors
- The person doing the interview is the person who wrote the data collection sheet, so it will limit the errors in the interview process.
- The variables are clearly defined and measurable.
- Collect information in a unified form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 60 and older entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City from December 2020 to May 2021.
Key inclusion criteria (1 listed)
- All patients ≥ 60 years of age agree to participate in the study.
Key exclusion criteria (1 listed)
- Disturbance or other cognitive disorders at the time of assessment at admission, hospital stay not exceeding 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incidence of Delirium in Inpatient Elderly PatientsStudy design: prospective cohort study. | Other | – |
Primary outcome
Incidence of Delirium in Inpatient Elderly Patients
Time frame: from December 2020 to May 2021
Incidence of Delirium in elderly patients entered the Geriatric Department of Gia Dinh People's Hospital in Ho Chi Minh City
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Incidence of Delirium in Inpatient Elderly Patients
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Incidence of Delirium in Inpatient Elderly Patients, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. 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 Vietnam. 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?
Results are not available in the source record.
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?
Incidence of Delirium in Inpatient Elderly Patients (time frame: from December 2020 to May 2021). 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 26 Nov 2019.