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

NCT06504251 | Completed

• 1 other identifier: COA no. Si 353/2022
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age; Hip Fractures; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of delirium in patients with fragility hip fractures before and after surgical treatment.

  3 day

Interventions

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).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkok, Bangkoknoi, 10700, Thailand

Location

MeSH Terms

Conditions

Hip Fractures; Delirium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: July 16, 2024
• Study Start: September 9, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 27, 2024
• Last Updated: September 15, 2025

Record last verified: 2024-07

Locations

TH (1)