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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041708
Receipt No. R000047270
Scientific Title Study of frailty for patients with rheumatoid arthritis
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/07

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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
Email 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
Email masayok@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
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
2020 Year 07 Month 29 Day
Date of IRB
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 questionnaire and are collected clinical information

Management information
Registered date
2020 Year 09 Month 07 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047270

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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