UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055541 |
|---|---|
| Receipt number | R000062086 |
| Scientific Title | Feasibility study of developing an occupational therapy program to prevent delirium in older patients with hip fracture |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/08/25 16:51:58 |
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Basic information
Public title
Feasibility study of developing an occupational therapy program to prevent delirium in older patients with hip fracture
Acronym
Feasibility study of developing an occupational therapy program to prevent delirium in older patients with hip fracture
Scientific Title
Feasibility study of developing an occupational therapy program to prevent delirium in older patients with hip fracture
Scientific Title:Acronym
Feasibility study of developing an occupational therapy program to prevent delirium in older patients with hip fracture
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an occupational therapy program to conduct ADL practice and group interaction in the morning to prevent (1) sleep-wake rhythm disorder, (2) physical and mental inactivity, and (3) limitation of social interaction, which are likely to occur in elderly patients after femur fracture surgery, and to verify the feasibility of its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium in the first 2 weeks postoperatively (CAM-S determination of presence or absence of delirium)
Key secondary outcomes
QOL (EQ-5D-5L), nighttime sleep time, etc.
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 no complications of trauma or fracture other than hip fracture
Key exclusion criteria
Patients with difficulty in leaving the bed according to the criteria of the Japanese Society for Bed Leaving
Patients who are unable to participate in group programs or ADL exercises conducted in occupational therapy for at least 3 days during the intervention period
Target sample size
40
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, 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, 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 JAPAN
Tel
0263372572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
YES
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
| 2024 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/psyg.70072
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/psyg.70072
Number of participants that the trial has enrolled
49
Results
A randomized controlled feasibility study of occupational therapy to establish a morning routine (OT-EMR) was conducted. The recruitment rate was 51.0%. The incidence of delirium was 45.5% in the OT-EMR group, with a median duration of 1.5 days, compared with 56.5% and 3.0 days in the control group. Mean QOL score on days 7 was 0.570 and 0.475 respectively. All the effect sizes were small. OT-EMR was feasible but showed only small effects on delirium incidence and QOL.
Results date posted
| 2025 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients aged 80 years or older who had undergone hip fracture surgery and were eligible to participate in group therapy were assigned. Twenty-two in the OT-EMR group and 23 in the control group were analyzed. The mean age of all the 45 patients was 89.2 years (SD=5.1), and most participants were female (n=39, 86.7%). The mean MMSE-J score was 15.8 (SD=7.8). No significant differences in the measured characteristics were observed between the OT-EMR and control groups.
Participant flow
A total of 118 patients underwent surgery for acute hip fracture between December 1, 2023 and March 22, 2024; 96 were over 80 years of age and 49 were included in the study (51.0% inclusion rate).Reasons for exclusion included the presence of trauma or fracture other than hip fracture, and diseases or disabilities that would interfere with participation in group therapy. After assignment, three patients from the OT-EMR group and one from the control group dropped out, leaving 22 and 23 patients for analysis, respectively.
Adverse events
None
Outcome measures
The incidence and duration of delirium measured by the Confusion Assessment Method (CAM).
QOL measured by the Euro Qol 5 Dimensions 5-Level (EQ-5D-5L) questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062086
