UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041708 |
|---|---|
| Receipt number | R000047270 |
| Scientific Title | Study of frailty for patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2022/09/19 10:57:40 |
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Basic information
Public title
Study of frailty for patients with rheumatoid arthritis
Acronym
Study of frailty for patients with rheumatoid arthritis
Scientific Title
Study of frailty for patients with rheumatoid arthritis
Scientific Title:Acronym
Study of frailty for patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the chronological change of frailty status and physical function and generic QOL index in patients with rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
To identify the items of the questionnaires for elderly associated with physical function and generic health status.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty assessed by Kihon Checklist
Key secondary outcomes
EQ5D, physical function, disease activity, SARC-F
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis who meet the 1987 criteria of ACR or the 2010 criteria of the ACR/EULAR and under the management of board cerified rheumatologists .
Key exclusion criteria
1) Age <65 year old.
2) Those who do not offer written informed consents.
3) Those who cannot complete the self-administarative questionnaire by themselves.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Kojima |
Organization
Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research
Zip code
4668601
Address
7-430Morioka, Obu, Aichi
TEL
0562-46-2311
masayok@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Kojima |
Organization
Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Division name
Department of Frailty Research
Zip code
4668601
Address
7-430Morioka, Obu, Aichi
TEL
0562-46-2311
Homepage URL
masayok@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University Hospital, Anjo Kosei Hospital, Toyota Kosei Hospital, Ishinomiya Municipal Hospital, Daido Hospital, Ito orthopedics hospital, Ito Clinic Orthopedics, Saito Clinic Orthopedics Rheumatology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology
Address
7-430Morioka, Obu, Aichi
Tel
0562-46-2311
masayok@ncgg.go.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
名古屋大学(愛知県）、安城更生病院(愛知県）、豊田厚生病院(愛知県）、一宮市立市民病院(愛知県）、大同病院(愛知県）、伊藤整形外科(愛知県）、さいとう整形外科リウマチ科(愛知県）、国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 07 | 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
867
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 | 07 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study subjects are Rheumatoid Arthritis patients who are aged 65 over and visit hospitals. Subjects are registered from September 2020 to March 2021. In 2020 and 2021, they answered a questionnaire and are collected clinical information
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047270
