The Southeast and East Asian Post-Operative Delirium (SEAPOD) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-22

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The specific aim of the study will be to investigate the incidences and risk factors for postoperative delirium (POD) after hip fracture surgery in elderly patients aged ≥ 65 years in five different Southeast and East Asian countries.

The secondary objectives are outlined below:

1. To investigate factors in the hospital environments, such as noise levels, ambient lighting, nursing ratios, ward bedding and climate control, that contribute to similarities and/or differences in POD occurrences in different countries and health systems
2. To investigate patient factors, such as disease burden, mental health, education levels, and socioeconomic factors, that contribute to similarities and/or differences in POD occurrences in different countries and health systems
3. To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore

NCT04330950

Postoperative Delirium

COMPLETED

Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients

NCT02131181

Postoperative Delirium

COMPLETED

Risk Factors for Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore

NCT04617210

Postoperative Delirium

UNKNOWN

Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery

NCT05105906

Delirium Cognitive Dysfunction

COMPLETED

Hip Fracture Surgery in Elderly Patients

NCT01199276

Delirium

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hip fractures encompass all fractures of the upper (proximal) part of the thigh bone (femur). They are commonly divided into two types: intracapsular fractures, which represent those that occur within or proximal to the attachment of the hip joint capsule to the femur, and extracapsular, which represent fractures occurring below or distal to the attachment of the hip joint capsule.

Hip fractures are common in elderly people with an annual incidence rate estimated as 1.29/1000 person-years in men and 2.24/1000 person-years in women. It is the most common condition requiring physical rehabilitation in older adults. The majority (\>95%) of people undergo hip surgery following hip fracture. The location of the fracture, stability, and degree of comminution (number of pieces the bone breaks into) determine which operative procedure should be used to repair the hip fracture. The aim of surgery, irrespective of the type of operation, is to reduce pain, facilitate early weight-bearing mobility to improve outcome, and facilitate independence in activities of daily living, such as bathing, dressing, and continence. However, hip fracture is associated with significant pain and loss of independence and function. Although 33-37% of patients return to their prior level of function within six months including those needing assistance, only 24% of people are independently mobile six months after hip fracture.

A major complication in elderly hip fracture patients is POD, with an incidence rate varying from 13% to 65%. POD after hip surgery was significantly associated with non-home discharge disposition, and higher odds of 30-day readmissions and 30-day mortality. POD is also associated with poor outcomes, such as lower rates of immediate postoperative weight bearing, increased pressure sores, and poorer recovery of activities of daily living. In addition, a recent meta-analysis showed that POD after hip surgery translates into long-term cognitive disease burden, by increasing the risk of incident dementia and cognitive decline by a marked odds ratio of 8.957.

No strong evidence exists regarding the treatment of delirium. Several studies performed on delirium prevention in hip fracture patients have described the use of care bundles such as orthogeriatric care and comprehensive geriatric care as an effective potential treatment for this patient group, although the evidence remains weak. However, Inouye et al stated that in the general geriatric population, 30% to 40% of the delirium episodes could be prevented by addressing modifiable risk factors.

Previous studies in the five Asian countries involved in this study show that the incidence of POD after hip fracture surgery varied greatly between countries and within countries: 12.8-27.9% in Japan, 5.07-51.3% in Korea, 13.4-45% in Thailand and 7.2% in Singapore. The incidence of POD in Malaysia can be estimated at 9-12% as reported in the recent HIP Attack trial. However, these studies were heterogenous in terms of patient selection, study methodology and hospital systems. These variations make it difficult to draw a direct comparison regarding the incidence of POD amongst Asian countries and to Western cohorts. Furthermore, the cost of POD to patients and institutions, both direct and indirect, is very poorly defined in Asian countries.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium Hip Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical Cohort

Elderly patients aged 65 and above who are planned for hip fracture surgery.

Neurocognitive tests

Intervention Type OTHER

Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, NuDESC, 3D-CAM.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurocognitive tests

Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, NuDESC, 3D-CAM.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ability to provide informed consent
* Elderly patients aged 65 years and above
* Scheduled to undergo elective or emergency hip fracture surgery

Exclusion Criteria

* History of psychiatric disease
* Baseline cognitive impairment or dementia (MOCA score \< 24)
* Illiterate (unable to read or write with local language)
* Active history of substance abuse
* Has a second surgery planned within 5 days of index surgery
* Non-resident of Singapore
* Significant hearing and/or speech impairment
* Planned for admission into the intensive care unit after surgery

Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lian Kah Ti

Role: PRINCIPAL_INVESTIGATOR

National University Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.