Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient

September 9, 2025 updated by: Mahidol University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkoknoi
      • Bangkok, Bangkoknoi, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
3 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of delirium in patients with fragility hip fractures before and after surgical treatment.
Time Frame: 3 day
Number of delirium in peri-operative fragility hip fracture in Siriraj hospital
3 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COA no. Si 353/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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