UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057278 |
|---|---|
| Receipt number | R000065453 |
| Scientific Title | Fatigue management program using a mental care app for patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/08/08 20:42:04 |
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Basic information
Public title
Fatigue management program using a mental care app for patients with inflammatory bowel disease
Acronym
Fatigue management program using a mental care app for patients with inflammatory bowel disease
Scientific Title
Fatigue management program using a mental care app for patients with inflammatory bowel disease
Scientific Title:Acronym
Fatigue management program using a mental care app for patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease, ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating effectiveness of a fatigue management program including psychotherapy using an app in patients with IBD in remission
Basic objectives2
Others
Basic objectives -Others
Exploring the relationship between the effect of reducing fatigue and the frequency of application use or other individual factors of the participants
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACIT-F
Key secondary outcomes
IBD-SES13
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
7-week fatigue management program utilizing mental care app
Interventions/Control_2
usual care (waiting list)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In clinical remission (CDAI < 150 for Crohn's disease, pMayo score < 1 for ulcerative colitis)
Have more than mild fatigue (FACIT-F Fatigue subscale score less than 40 points)
Able to understand the study description in Japanese and agree to participate in the intervention study (RCT).
Key exclusion criteria
No environment to use the application.
Currently treated at a psychiatric or psychosomatic clinic
Participating in another clinical trial and not allowed to participate in other studies
Inability to come to the hospital 2-5 months after the intervention
In addition, the investigator deems the subject unsuitable for the study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Tanaka |
Organization
Institute of Science Tokyo
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku Tokyo JAPAN
TEL
0358035351
tanaka.cc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Tanaka |
Organization
Institute of Science Tokyo
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku Tokyo JAPAN
TEL
0358035351
Homepage URL
tanaka.cc@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo (Former Tokyo Medical and Dental University)
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinshukai Infusion Clinic
Awarefy Inc.
Name of secondary funder(s)
Awarefy Inc.
IRB Contact (For public release)
Organization
The Ethics Review Committee of the Faculty of Medicine of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku Tokyo JAPAN
Tel
0338136111
rinri.adm@tmd.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
| 2025 | Year | 06 | Month | 01 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065453
