NCT04999891

Brief Summary

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. 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. 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. 3.To quantify the direct and indirect costs, as well as resource utilization, resulting from the development of POD in each country

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
5 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

August 22, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

June 24, 2021

Last Update Submit

October 4, 2022

Conditions

Postoperative DeliriumHip Fractures

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (1)

  • Development of POD in elderly patients undergoing hip fracture surgery

    Collection of patient's demographics, medical records and surgical records to establish risk factors for POD development

    Before surgery through to 1 year post surgery

Secondary Outcomes (2)

  • Healthcare cost of POD in different countries and health systems

    Before surgery through to study completion, an average of 1 year

  • Similarities and/or differences in POD occurrences in different countries and health systems

    Before surgery through to 1 year post surgery

Study Arms (1)

Surgical Cohort

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

Other: Neurocognitive tests

Interventions

Neurocognitive testsOTHER

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.

Surgical Cohort

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients aged 65 and above scheduled to undergo hip fracture surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Tohoku University School of Medicine

Sendai, Japan

NOT YET RECRUITING

Tokyo Women's Medical University

Tokyo, Japan

NOT YET RECRUITING

University of Malaya

Kuala Lumpur, Malaysia

NOT YET RECRUITING

Universiti Sains Malaysia

Malacca, Malaysia

NOT YET RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

NOT YET RECRUITING

Khoo Teck Puat Hospital

Singapore, Singapore

NOT YET RECRUITING

National University Health System

Singapore, Singapore

RECRUITING

Ng Teng Fong General Hospital

Singapore, Singapore

NOT YET RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

NOT YET RECRUITING

Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

St Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

NOT YET RECRUITING

Siriraj Hospital

Bangkok, Thailand

NOT YET RECRUITING

Related Publications (5)

  • Adams AL, Shi J, Takayanagi M, Dell RM, Funahashi TT, Jacobsen SJ. Ten-year hip fracture incidence rate trends in a large California population, 1997-2006. Osteoporos Int. 2013 Jan;24(1):373-6. doi: 10.1007/s00198-012-1938-5. Epub 2012 Feb 21.

    PMID: 22349963BACKGROUND

  • Lenze EJ, Skidmore ER, Dew MA, Butters MA, Rogers JC, Begley A, Reynolds CF 3rd, Munin MC. Does depression, apathy or cognitive impairment reduce the benefit of inpatient rehabilitation facilities for elderly hip fracture patients? Gen Hosp Psychiatry. 2007 Mar-Apr;29(2):141-6. doi: 10.1016/j.genhosppsych.2007.01.001.

    PMID: 17336663BACKGROUND

  • Uzoigwe CE, Burnand HG, Cheesman CL, Aghedo DO, Faizi M, Middleton RG. Early and ultra-early surgery in hip fracture patients improves survival. Injury. 2013 Jun;44(6):726-9. doi: 10.1016/j.injury.2012.08.025. Epub 2012 Sep 23.

    PMID: 23010072BACKGROUND

  • Handoll HH, Cameron ID, Mak JC, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007125. doi: 10.1002/14651858.CD007125.pub2.

    PMID: 19821396BACKGROUND

  • Morrison RS, Ahronheim JC, Morrison GR, Darling E, Baskin SA, Morris J, Choi C, Meier DE. Pain and discomfort associated with common hospital procedures and experiences. J Pain Symptom Manage. 1998 Feb;15(2):91-101.

    PMID: 9494307BACKGROUND

MeSH Terms

Conditions

Emergence DeliriumHip Fractures

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Lian Kah Ti

    National University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Kah Ti

CONTACT

6772 4200anatilk@nus.edu.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

August 11, 2021

Study Start

August 22, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)TH(2)JP(2)MY(2)SG(5)