UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044463 |
|---|---|
| Receipt number | R000050772 |
| Scientific Title | A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2022/12/10 11:00:51 |
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Basic information
Public title
A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Acronym
A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Scientific Title
A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Scientific Title:Acronym
A survey of treatment goals and mutual understanding between patients and physicians in terms of the treatment of rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the treatment of rheumatoid arthritis (RA), one of the important factor for improving satisfaction in patients is considered as closing gaps between patients with RA and physicians about treatment goals. The aim of this survey is to understand currently existing gaps.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences between the importance of treatment goals in patients, that in physicians, and that in patients understood by physicians.
Key secondary outcomes
- The difference between the importance of treatment goals in patients and the importance of inhibition of joint destruction for achieving goals,
- The difference between the importance of treatment goals in patients and goals presented by physicians,
- The difference between information that patients want to express to physicians, that patients expressed to physicians, and that were presented by physicians,
- The difference between information that patients expressed to physicians and that physicians asked to patients,
- The difference between consent of patients and and consent of patients that physicians understand to goals presented by physicians,
- The difference between satisfaction of patients to goals presented by physicians and consent of patients that physicians understand,
- The factors associating with satisfaction and consent of patients,
- The difference between the importance of long-term and short-term treatment goals in patients,
- The difference between the importance of long-term and short-term treatment goals in physicians.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A) Patients survey
Include patients eligible for the all following criteria from patients registered in MHP:
(i) Patients with history of diagnosis with RA;
(ii) Patients currently prescribed with medications for RA.
B) Physicians survey
Include physicians eligible for the all following criteria:
(i) Physicians who work in any following department: rheumatology, general internal medicine, orthopedics;
(ii) Physicians who have more than 4 patients with RA at the date of the survey.
Key exclusion criteria
A) Patients survey
Exclude patients with any one following criteria:
(i) Patients who work for any of the following organizations
- market research companies
- media companies
- advertising companies
- hospitals or clinics
- pharmaceutical companies
- pharmaceutical wholesalers
(ii) Patients with any one following criteria
- without history of medical treatment for RA
- with history of medical treatment for RA which is withdrawn
- with history of medical treatment for RA which is determined
B) Physicians survey
Exclude physicians without any one inclusion criteria.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takehana |
Organization
Medilead Inc.
Division name
Marketing Intelligence Dept.
Zip code
163-1424
Address
Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL
03-6859-2295
j_takehana@medi-l.com
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Wakita |
Organization
Medilead Inc.
Division name
Marketing Intelligence Dept.
Zip code
163-1424
Address
Tokyo Opera City Tower, 3-20-2 Nishishinjuku, Shinjuku-ku, Tokyo 163-1424 JAPAN
TEL
03-6859-2295
Homepage URL
e_wakita@medi-l.com
Sponsor or person
Institute
Others
Eisai Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Others
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japanese Association for the Promotion of State-of-the-Art in Medicine
Address
2-24-2, Chikusa, Chikusa, Nagoya, Aichi, Japan
Tel
052-745-6881
info-irb@japsam.or.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
| 2021 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
This is a cross-sectional study using a web-based questionnaire survey. All responses will be anonymized directly after responders complete their answers.
Management information
Registered date
| 2021 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050772
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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