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

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: Completed
• Conditions: Delirium; Hip Fractures; Old Age
• Intervention / Treatment: Diagnostic test: Delirium Diagnostic Tool-Provisional ( DDT-Pro )

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: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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).	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

Outcome Measure	Measure Description	Time Frame
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	3 day

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Fractures, Bone; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Hip Fractures
• Other Study ID 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