UMIN-CTR Clinical Trial

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	10th Floor, Toranomon33 Mori Bldg., 3-8-21 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	https://link.springer.com/article/10.1007%2Fs00535-021-01811-1
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007%2Fs00535-021-01811-1
Number of participants that the trial has enrolled	457
Results	This web-based survey in patients with ulcerative colitis revealed that adequate physician-patient communication, especially physician-to-patient information, enhanced patient satisfaction with treatment decision-making for ulcerative colitis.
Results date posted	2021 Year 08 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 27 Day
Baseline Characteristics	Patients aged over？20 years with UC were recruited from the IBD Patient Panel and Japanese IBD Patient Association.
Participant flow	Patients completed our web-based survey between 11 May and 1 June 2020.
Adverse events	Not applicable
Outcome measures	The main outcomes were patient satisfaction (assessed by the Decision Regret Scale) and patient trust in physicians (assessed by the Trust in Physician Scale).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 11 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	2020 Year 06 Month 09 Day
Date analysis concluded	2020 Year 07 Month 30 Day

Other
Other related information	N/A

Management information
Registered date	2020 Year 05 Month 09 Day
Last modified on	2021 Year 08 Month 04 Day

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