UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038053 |
|---|---|
| Receipt number | R000040741 |
| Scientific Title | Epidemiological QOL study of patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2022/09/19 10:52:05 |
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Basic information
Public title
Epidemiological QOL study of patients with rheumatoid arthritis
Acronym
RA epidemiological QOL study
Scientific Title
Epidemiological QOL study of patients with rheumatoid arthritis
Scientific Title:Acronym
RA epidemiological QOL study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the epidemiological characteristics of rheumatoid arthritis focusing on health-related QOL.
Basic objectives2
Others
Basic objectives -Others
We will follow the patients for two year and identify the risk factor of care dependency.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Care dependency
Key secondary outcomes
Activities on daily living
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis who meet the 2010 criteria of the ACR/EULAR and under the management of board cerified rheumatologists .
Key exclusion criteria
Age <40 or >=80 year old.
Those who do not offer written informed consents.
Those who cannot complete the self-administarative questionnaire by themselves.
Target sample size
500
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 | Sadao |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Public Health
Zip code
4668601
Address
Kawasumi1, Mizuho, Nagoya
TEL
0528538176
Homepage URL
masayok@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japanese Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
Kawasumi1, Mizuho, Nagoya
Tel
052-853-7215
irb_jimu@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
60-18-0171
Org. issuing International ID_1
Nagoya City University Graduate School of Medical Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋市立大学病院（愛知県）
名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 19 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who meet the research criteria are invited to participate in the baseline survey by rheumatologists when they visit the outpatient rheumatology clinics. Self-administrative questionnaire is handed by rheumatologists to the patients who give written informed consents. The patients complete the questionnaires and return them by mail. Number of swelling and/or tender joints, CRP value and clinical history are recorded. Combine clinical and questionnaire data will be analyzed to detect epidemiological characteristics of each generation. After 2 years, we conduct a follow-up survey by mailing method and estimate the risk factor of care dependency.
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | 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=R000040741
