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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in Vietnam

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:

  1. Determine the incidence of delirium in elderly patients in general geriatric department.
  2. Investigate some of the important related factors that are common for delirium in elderly patients in general geriatric department.
  3. 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.

  1. 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.

  1. First posted26 Nov 2019
  2. Study start15 Dec 2020 (estimated)
  3. Primary completion15 May 2021 (estimated)
  4. Study completion15 Aug 2021 (estimated)

Resources

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)
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

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.

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