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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040343
Receipt No. R000045916
Scientific Title Impact of Physician-Patient Information on Patient Satisfaction in Determining Treatment Strategies for Patients with Ulcerative Colitis.
Date of disclosure of the study information 2020/05/10
Last modified on 2020/11/08

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Basic information
Public title Impact of Physician-Patient Information on Patient Satisfaction in Determining Treatment Strategies for Patients with Ulcerative Colitis.
Acronym Impact of Physician-Patient Information on Patient Satisfaction in Determining Treatment Strategies for Patients with Ulcerative Colitis.
Scientific Title Impact of Physician-Patient Information on Patient Satisfaction in Determining Treatment Strategies for Patients with Ulcerative Colitis.
Scientific Title:Acronym Impact of Physician-Patient Information on Patient Satisfaction in Determining Treatment Strategies for Patients with Ulcerative Colitis.
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We conduct a web-based questionnaire survey for patients with ulcerative colitis to clarify the relationship between the amount of information shared by physicians and patients and patient satisfaction with decisions on treatment strategy. Also, to identify the types of information which the patients consider as insufficient.
Basic objectives2 Others
Basic objectives -Others Patient satisfaction with decisions on treatment strategy
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Patient satisfaction with decisions on treatment strategy
Key secondary outcomes *Trust in physician scale
*Amount of information by type of information between physicians and patients
*Patients characteristics (demographics and clinical characteristics)
*Preference for decision-making (Autonomy Preference Index)

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 Patients with ulcerative colitis aged over 20 years.
Patients who regularly visit the hospital for the treatment of ulcerative colitis (About once in 3 months).
Patients who consented via the web to participate in the present research.
Key exclusion criteria No specific criteria
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Katsuyoshi
Middle name
Last name Matsuoka
Organization Toho University Sakura Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code 285-0841
Address 564-1, Shimoshizu, Sakura City, Chiba
TEL 043-462-8811
Email matsuoka@fk2.so-net.ne.jp

Public contact
Name of contact person
1st name Yuriko
Middle name
Last name Kitahara
Organization QLife Co., Ltd.
Division name Medical Solution
Zip code 105-0001
Address 7th Floor, Sumitomo Shin-Toranomon Bldg., 4-3-9 Toranomon, Minato-ku, Tokyo
TEL 03-6860-5020
Homepage URL
Email y-kitahara@qlife.co.jp

Sponsor
Institute Toho University Sakura Medical Center
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Mitsubishi Tanabe Pharma Corporation
Name of secondary funder(s) Janssen Pharmaceutical K.K.

IRB Contact (For public release)
Organization Medical corporation Takahashi clinic clinical trial examination committee
Address Medical Hat, 1st floor, 1-31, Iwayakitamachi, Nada-ku, Kobe-shi, Hyogo
Tel 03-43662-4504
Email no-mori@mebix.co.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
2020 Year 05 Month 10 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 Enrolling by invitation
Date of protocol fixation
2020 Year 04 Month 10 Day
Date of IRB
2020 Year 04 Month 21 Day
Anticipated trial start date
2020 Year 05 Month 08 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
2020 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2020 Year 05 Month 09 Day
Last modified on
2020 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045916

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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