Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-03-05 @ 6:40 PM
Study NCT ID:
NCT06504251
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays, the number of hip fracture patients is increasing. As Thailand enters into an aging society, hip fractures are becoming more common. They are typically treated with surgery. Complications, such as urinary tract infections, pressure sores, and acute confusion, are often observed. These various complications contribute to an increased rate of illness and death.
Delirium is a common problem among hip fracture patients. Currently, diagnosis is typically made using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), which is a standard tool. However, utilizing it effectively requires expertise. Additionally, other tools such as the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) are available. Nonetheless, training is necessary for their proper use, and they may be more suitable for specific patient groups.
The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to aid in diagnosing delirium. Unlike other tools, it does not require specialized training. It can assess the main symptoms of delirium, including cognitive ability, higher-level thinking skills, and the sleep-wake cycle. This tool has been utilized in foreign countries such as Spain. The tool was found to have good accuracy and reliability and is useful in aiding the diagnosis of delirium. However, it has never been translated and tested for use in elderly Thai patients with fragility hip fractures.
Delirium is a common problem among hip fracture patients. Currently, diagnosis is typically made using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), which is a standard tool. However, utilizing it effectively requires expertise. Additionally, other tools such as the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) are available. Nonetheless, training is necessary for their proper use, and they may be more suitable for specific patient groups.
The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to aid in diagnosing delirium. Unlike other tools, it does not require specialized training. It can assess the main symptoms of delirium, including cognitive ability, higher-level thinking skills, and the sleep-wake cycle. This tool has been utilized in foreign countries such as Spain. The tool was found to have good accuracy and reliability and is useful in aiding the diagnosis of delirium. However, it has never been translated and tested for use in elderly Thai patients with fragility hip fractures.
Detailed Description:
Inclusion criteria
* Patients older than 65 years
* Had a hip fracture within 7 days before receiving treatment at Siriraj Hospital
* Received surgical treatment for a hip fracture
Exclusion criteria
* Unable to communicate in Thai
* Was diagnosed with cancer before or during treatment for a hip fracture
* Have a history of schizophrenia
* Patients infected with COVID-19
Primary outcomes include:
Validity: Conducting concurrent validity to examine the relationship between the Thai version of DDT-Pro and the Thai version of DSM-V using the 95% confidence interval (CI) for the AUC statistic.
Reliability: Determining the internal consistency of the tool through Cronbach's Alpha with a 95% confidence level, and assessing inter-rater reliability using the 95% CI for Kappa statistic.
Secondary outcomes include:
Prevalence of delirium in patients undergoing surgery for fragility hip fractures
* Patients older than 65 years
* Had a hip fracture within 7 days before receiving treatment at Siriraj Hospital
* Received surgical treatment for a hip fracture
Exclusion criteria
* Unable to communicate in Thai
* Was diagnosed with cancer before or during treatment for a hip fracture
* Have a history of schizophrenia
* Patients infected with COVID-19
Primary outcomes include:
Validity: Conducting concurrent validity to examine the relationship between the Thai version of DDT-Pro and the Thai version of DSM-V using the 95% confidence interval (CI) for the AUC statistic.
Reliability: Determining the internal consistency of the tool through Cronbach's Alpha with a 95% confidence level, and assessing inter-rater reliability using the 95% CI for Kappa statistic.
Secondary outcomes include:
Prevalence of delirium in patients undergoing surgery for fragility hip fractures
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: