UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040343 |
|---|---|
| Receipt number | 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 | 2021/08/04 11:44:28 |
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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
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
y-kitahara@qlife.co.jp
Sponsor or person
Institute
Toho University Sakura Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045916
