UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047246 |
|---|---|
| Receipt number | R000053750 |
| Scientific Title | Effects of cognitive behavioral interventions based on shared decision making for hip fractures |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2024/09/18 21:34:15 |
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Basic information
Public title
Effects of cognitive behavioral interventions based on shared decision making for hip fractures
Acronym
Effects of cognitive behavioral interventions based on shared decision making for hip fractures
Scientific Title
Effects of cognitive behavioral interventions based on shared decision making for hip fractures
Scientific Title:Acronym
Effects of cognitive behavioral interventions based on shared decision making for hip fractures
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hip fractures are osteoporotic fractures that occur frequently in the elderly, and more than 90% of them are selected for surgery. After surgery, standard rehabilitation such as range of motion training, strength training, and walking exercises are practiced with the aim of improving ADL. However, the current situation is that the improvement of physical function and physical activity to live comfortably in the town is insufficient. Recently, it has been said that cognitive-behavioral intervention based on shared decision-making is effective in promoting improvement in physical activity. Therefore, in this study, we examine the effect of combined cognitive-behavioral intervention based on shared decision-making that contributes to the improvement of physical function and QOL of patients after hip fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical activity
Key secondary outcomes
pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
standard intervention plus cognitive behavioral intervention based on shared decision making.
from 2 weeks after surgery at discharge.
daily intervention
Interventions/Control_2
standard intervention.
from 2 weeks after surgery at discharge.
daily intervention.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Injured hip fracture
Those who lived independently by walking alone or walking with a T-shaped cane before the injury
Those who can understand Japanese
Those who have agreed to participate in the study
Key exclusion criteria
Injured with high energy such as falling from high place
Those who have cognitive decline with MMSE of 23 points or less 2 weeks after surgery
Those who were discharged within 4 weeks after surgery
Persons with severe visual impairment
Diseases that interfere with rehabilitation
Persons with disabilities
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kyo |
| Middle name | |
| Last name | Goto |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Health Sciences Physical therapy
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
09065885456
gottsu_hibiku@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kyo |
| Middle name | |
| Last name | Goto |
Organization
Nagasaki Memorial Hospital
Division name
Rehabilitation department
Zip code
851-0301
Address
1-11-54 Fukahori machi, Nagasaki City, Nagasaki Prefecture
TEL
095-871-1515
Homepage URL
gottsu_hibiku@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Biomedical Sciences, Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7967
miyaji195@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053750
