Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04177589 |
| Other study ID # |
NTL |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2020 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
November 2019 |
| Source |
Ho Chi Minh City University of Medicine and Pharmacy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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:
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.
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.
