Old AgeNCT06504251
Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient
An observational study of Old Age and Hip Fractures, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age, Hip Fractures, Delirium
- What is being tested?
- Delirium Diagnostic Tool-Provisional ( DDT-Pro )
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- 9 Sep 2022to 27 Feb 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The main objective of the study is to assess the validity and reliability (DDT-Pro) questionnaire in patients with fragility hip fractures before and after receiving surgical treatment. For evaluating the Concurrent validity of the tool: 1. Concurrent validity (95% Confidence Interval (CI) for the Area Under the Curve (AUC)) - sample size = 99 2. For reliability assessment (Reliability) of the tool: 1. Internal consistency (95% confidence level for Cronbach's Alpha) - sample size = 90 2. Inter-rater reliability (95% confidence interval for Kappa) - sample size = 66 Therefore, the sample size for analyzing inter-rater reliability is at least 66 cases, the sample size for analyzing internal consistency is at least 90 cases, and the sample size for concurrent validity analysis is at least 99 cases. However, the researcher expected a 10% dropout rate, so a sample size of at least 110 cases was used for the analysis.
Who may be able to join
- Patients older than 65 years
- Hip fracture within a period of 7 days
- Receiving treatment at Siriraj Hospital and who have undergone surgical treatment for the hip fracture.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Old Age, Hip Fractures, Delirium
- Being tested
- Delirium Diagnostic Tool-Provisional ( DDT-Pro )
- Medical subject headings
- Hip Fractures, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium Diagnostic Tool-Provisional ( DDT-Pro )Diagnostic test
The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to assist in the diagnosis of delirium. It does not require specialist expertise. It can assess the main symptoms of acute confusion, including cognitive ability (Cognition), higher-level thinking skills (Higher level thinking), and the sleep-wake cycle (Sleep-wake cycle).
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro).
Accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro) compared with the gold standard tool (DSM V)
Measured: 3 day
Secondary outcomes (1)
The incidence of delirium in patients with fragility hip fractures before and after surgical treatment.
Number of delirium in peri-operative fragility hip fracture in Siriraj hospital
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start9 Sep 2022
- Primary completion21 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504251
- Sponsor's protocol ID
- COA no. Si 353/2022
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient
- ClinicalTrials.gov ID
- NCT06504251
- Acronym / sponsor ID
- COA no. Si 353/2022
- Conditions
- Old Age, Hip Fractures, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 16 Jul 2024 (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.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The main objective of the study is to assess the validity and reliability (DDT-Pro) questionnaire in patients with fragility hip fractures before and after receiving surgical treatment. For evaluating the Concurrent validity of the tool: 1. Concurrent validity (95% Confidence Interval (CI) for the Area Under the Curve (AUC)) - sample size = 99 2. For reliability assessment (Reliability) of the tool: 1. Internal consistency (95% confidence level for Cronbach's Alpha) - sample size = 90 2. Inter-rater reliability (95% confidence interval for Kappa) - sample size = 66 Therefore, the sample size for analyzing inter-rater reliability is at least 66 cases, the sample size for analyzing internal consistency is at least 90 cases, and the sample size for concurrent validity analysis is at least 99 cases. However, the researcher expected a 10% dropout rate, so a sample size of at least 110 cases was used for the analysis.
Key inclusion criteria (3 listed)
- Patients older than 65 years
- Hip fracture within a period of 7 days
- Receiving treatment at Siriraj Hospital and who have undergone surgical treatment for the hip fracture.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Delirium Diagnostic Tool-Provisional ( DDT-Pro )The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to assist in the diagnosis of delirium. It does not require specialist expertise. It can assess the main symptoms of acute confusion, including cognitive ability (Cognition), higher-level thinking skills (Higher level thinking), and the sleep-wake cycle (Sleep-wake cycle). | Diagnostic test | – |
Primary outcome
To evaluate the accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro).
Time frame: 3 day
Accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro) compared with the gold standard tool (DSM V)
1 secondary outcome
The incidence of delirium in patients with fragility hip fractures before and after surgical treatment.
Time frame: 3 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Old Age and Hip Fractures, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro). (time frame: 3 day). 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 15 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.