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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044463
Receipt No. 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 2021/06/07

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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
Email 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
Email e_wakita@medi-l.com

Sponsor
Institute Others
Eisai Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 01 Day
Date of IRB
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
Date trial data considered complete
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
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050772

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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