UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042552 |
|---|---|
| Receipt number | R000047461 |
| Scientific Title | Effect of self-management program by e-learning on severity and quality of life for irritable bowel syndrome: a randomized controlled trial. |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2024/01/25 11:36:25 |
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Basic information
Public title
Effect of self-management program by e-learning on severity and quality of life for irritable bowel syndrome: a randomized controlled trial.
Acronym
Effect of self-management program by e-learning on severity and quality of life for irritable bowel syndrome: a randomized controlled trial.
Scientific Title
Effect of self-management program by e-learning on severity and quality of life for irritable bowel syndrome: a randomized controlled trial.
Scientific Title:Acronym
Effect of self-management program by e-learning on severity and quality of life for irritable bowel syndrome: a randomized controlled trial.
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of a 2-month e-learning program for IBS in improving symptoms and quality of life in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
IBS-severity (IBS-SI)
Key secondary outcomes
IBS-QOL
percentage of moderate and severe IBS
electroencephalogram
intestinal bacteria
food intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
self-management program
Interventions/Control_2
No treatment group
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
| 18 | years-old | <= |
Age-upper limit
| 36 | years-old | > |
Gender
Female
Key inclusion criteria
Japanese
Female
18 years old and under 36 years old
Key exclusion criteria
Have received drug treatment for IBS in the past
Person with mental illness
Organic gastrointestinal diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192, Japan
TEL
+81-4-2947-6756
jtayama@waseda.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Tayama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192, Japan
TEL
+81-4-2947-6756
Homepage URL
jtayama@waseda.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
apan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee in Saitama Prefectural University
Address
820, Sannomiya, Koshigaya, Saitama, 343-8540, Japan
Tel
048-971-0500
rinri@spu.ac.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 | 11 | Month | 25 | 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
40
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
| 2020 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
