UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057183 |
|---|---|
| Receipt number | R000065344 |
| Scientific Title | Effects of occupational therapy for establishing a morning routine to prevent delirium after hip fracture surgery |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2026/04/30 14:43:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of occupational therapy for establishing a morning routine to prevent delirium after hip fracture surgery
Acronym
Effects of occupational therapy for establishing a morning routine to prevent delirium after hip fracture surgery
Scientific Title
Effects of occupational therapy for establishing a morning routine to prevent delirium after hip fracture surgery
Scientific Title:Acronym
Effects of occupational therapy for establishing a morning routine to prevent delirium after hip fracture surgery
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether OT-EMR is effective in preventing postoperative delirium and psychologically stabilizing elderly cognitively impaired patients with hip fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium 2 weeks after surgery as determined by Confusion Assessment Method-S with or without delirium, and severity of delirium as determined by Confusion Assessment Method-S score.
Key secondary outcomes
Patient loneliness at 2, 7, and 14 days after surgery and at discharge as assessed by Short-form UCLA scores.
Quality of life of patients at 7 days, 14 days and discharge after surgery assessed by Euro Qol 5 Dimensions 5-Level scores.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Delirium prevention occupational therapy program
Interventions/Control_2
Standard occupational therapy program
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute proximal femur fracture who underwent surgery.
Patients with no complications of trauma or fracture other than hip fracture.
Patients with cognitive impairment on admission.
Key exclusion criteria
Patients with difficulty in leaving the bed according to the criteria of the Japanese Society for Bed Leaving.
Patients admitted to wards other than the orthopedic ward after surgery.
Patients with severe dementia who were unable to communicate before the injury.
Patients who did not give consent.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
TEL
0263372395
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
TEL
0263372395
Homepage URL
tkamimu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University, Life Science and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
Tel
0263372572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
23k10399
Org. issuing International ID_1
apan Society for the Promotion of Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065344
