UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051864 |
|---|---|
| Receipt number | R000059177 |
| Scientific Title | Effect of Defecation Care based on Defecation diary app for Hospitalized and Institutionalized Elderly Individuals with Defecation Disorders |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2023/08/08 14:44:38 |
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Basic information
Public title
Effect of Defecation Care based on Defecation diary app for Hospitalized and Institutionalized Elderly Individuals with Defecation Disorders
Acronym
Effect of Defecation Care based on Defecation diary app for Elderly Individuals with Defecation Disorders
Scientific Title
Effect of Defecation Care based on Defecation diary app for Hospitalized and Institutionalized Elderly Individuals with Defecation Disorders
Scientific Title:Acronym
Effect of Defecation Care based on Defecation diary app for Elderly Individuals with Defecation Disorders
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of defecation care provided by a multidisciplinary team based on a defecation diary app algorithm for elderly individuals with defecation disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the frequency of normal stools (Bristol Stool Form Scale 3-5) per week between the two weeks before the conventional defecation care and four weeks after the implementation of the new defecation care.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Provide defecation care by a multidisciplinary team based on a defecation diary app algorithm for subjects who had received conventional defecation care.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are 65 years of age or older at the time of consent
2.Patients who have been receiving enteral nutrition at the time of consent
3.Patients who have been hospitalized for more than four weeks and have had their defecation movements evaluated using the Bristol Stool Form Scale prior to consent
4.Patients who have been receiving conventional defecation care for more than three weeks at the time of consent and have been suffering from chronic functional constipation or diarrhea symptoms.
5.Patients who are capable of understanding the study content and providing informed consent either personally or through a proxy.
Key exclusion criteria
1.Patients with the following conditions at the time of consent, in which medical intervention for defecation control is difficult due to unstable medical conditions;
a. Malignant tumors
b. Previous resection of the digestive tract
c. Severe adhesions in the intestine
d. Liver disease
e. Thyroid disease
f. Poorly controlled diabetes
g. Rectal stenosis due to hemorrhoids
h. Other patients deemed ineligible by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Nishimura |
Organization
Continence Japan co., Ltd.
Division name
Managing Director
Zip code
167-0041
Address
1-4-2 Zenpukuji, Suginami-ku, Tokyo
TEL
03-3301-3872
knishimura@continence.co.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Nishimura |
Organization
Continence Japan co., Ltd.
Division name
Managing Director
Zip code
167-0041
Address
1-4-2 Zenpukuji, Suginami-ku, Tokyo
TEL
03-3301-3872
Homepage URL
knishimura@continence.co.jp
Sponsor or person
Institute
Continence Japan co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Continence Japan co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Omoto-kai General Headquarters
Address
1000 Ameku, Naha-shi, Okinawa
Tel
098-876-7010
goya-tooru@group.omotokai.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
| 2023 | Year | 08 | Month | 08 | 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
| 2023 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2033 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059177
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| Registered date | File name |
| Research case data | |
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