UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039187 |
|---|---|
| Receipt number | R000044610 |
| Scientific Title | Development of joint protection nursing program in a patient with rheumatoid arthritis |
| Date of disclosure of the study information | 2020/01/17 |
| Last modified on | 2024/01/22 07:49:15 |
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Basic information
Public title
Development of joint protection nursing program in a patient with rheumatoid arthritis
Acronym
Development of joint protection nursing program in a patient with rheumatoid arthritis
Scientific Title
Development of joint protection nursing program in a patient with rheumatoid arthritis
Scientific Title:Acronym
Development of joint protection nursing program in a patient with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After giving an evaluation of joint destruction for rheumatoid arthritis patients, self-exercise guidance was given as joint protection guidance, and the comparative study of the degree of joint destruction before and after the intervention showed that the joint protection measures program of this study verify that progress is suppressed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in joint destruction one year after intervention
Key secondary outcomes
Hand function, clinical test values, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Joint protection guidance
Self exercise guidance
When patients participate in the study, the frequency of consultation is the same as in regular practice Intervention, exercise status and evaluation at consultation.
At the time of intervention, 3, 6, 9, 12 months later
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those diagnosed with rheumatoid arthritis
Men and women between the ages of 20 to 80 at the time of registration
Informed consent has been obtained from the subject before enrollment in this study
Key exclusion criteria
At the time of obtaining consent,
A history of upper limb fracture or upper limb joint surgery in the past 6 months
Persons on the waiting list for upper limb orthopedic surgery
Pregnant women
When it is judged that participation in this study is inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kosaku |
| Middle name | |
| Last name | Murakami |
Organization
Kyoto University Hospital
Division name
Clinical immunology and Rheumatology
Zip code
606-8507
Address
54 Kawaharascho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-4380
kosaku@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Saeki |
Organization
Kyoto Prefectural University of Medicine
Division name
School of Nursing
Zip code
602-0857
Address
410 ,Nakagoryo-cho,Kamigyo-ku,Kyoto,602-0857,JAPAN
TEL
075-212-5435
Homepage URL
ryoko715@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501,JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院(京都府) Kyoto University Hospital (Kyoto)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 17 | 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
47
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
