UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047889 |
|---|---|
| Receipt number | R000054599 |
| Scientific Title | Effectiveness of an intervention by a multidisciplinary defecation support team |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2023/05/31 19:01:07 |
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Basic information
Public title
Effectiveness of an intervention by a multidisciplinary defecation support team
Acronym
Effectiveness of an intervention by a defecation support team
Scientific Title
Effectiveness of an intervention by a multidisciplinary defecation support team
Scientific Title:Acronym
Effectiveness of an intervention by a defecation support team
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of the defecation support team's intervention based on the defecation care algorithm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of spontaneous bowel movements of Bristol Stool Scale 3-5 points during the day
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Algorithm-based constipation care
Interventions/Control_2
usual constipation care
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
Patients who have discomfort or need related to defecation, but do not always communicate it correctly
Patients receiving oral or enteral nutrition
Patients scheduled to be hospitalized for more than 2 weeks at the time of inclusion
Key exclusion criteria
Patients with a history of organic constipation
Patients receiving nutrition only by intravenous feeding
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Tsuda |
Organization
Ishikawa Prefectural Nursing University
Division name
Graduate School of Nursing
Zip code
0761-48-3196
Address
1-1 Gakuendai, Kahoku City, Ishikawa, Japan
TEL
0761-48-3196
hiroko.tsuda@komatsu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Tsuda |
Organization
Ishikawa Prefectural Nursing University
Division name
Graduate School of Nursing
Zip code
9291210
Address
1-1 Gakuendai, Kahoku City, Ishikawa, Japan
TEL
9291210
Homepage URL
hiroko.tsuda@komatsu-u.ac.jp
Sponsor or person
Institute
Ishikawa Prefectural Nursing University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Wound, Ostomy and Continence Management
Social Insurance Union of Societies Related to Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ishikawa Prefectural Nursing University Ethics Committee
Address
1-1 Gakuendai, Kahoku City, Ishikawa, Japan
Tel
076-281-8300
office @ishikawa-nu.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
| 2022 | Year | 05 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2022 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054599
