UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039347 |
|---|---|
| Receipt number | R000044877 |
| Scientific Title | Implementation and evaluation of intervention for constipation among bedridden elderly. |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2023/01/31 11:30:10 |
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Basic information
Public title
Implementation and evaluation of intervention for constipation among bedridden elderly.
Acronym
Implementation and evaluation of intervention for constipation among bedridden elderly.
Scientific Title
Implementation and evaluation of intervention for constipation among bedridden elderly.
Scientific Title:Acronym
Implementation and evaluation of intervention for constipation among bedridden elderly.
Region
| Japan |
Condition
Condition
Chronic Constipation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Practice and evaluate intervention for constipation (Discontinuation of stimulant laxatives / Acupuncture point compression / Defecation posture by toilet seat position) designed based on the 2017 survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
Defecation volume and Stool form / Potential difference and number of contractions of colorectal smooth muscle/ Stool and gas storage in colon
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Discontinuation of stimulant laxatives (2 weeks) / Daily use of stimulant laxatives
Interventions/Control_2
Acupuncture point compression(4 weeks) / Daily use of stimulant laxatives
Interventions/Control_3
Defecation posture by toilet seat position(4 weeks)/ Daily use of stimulant laxatives
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
Over 65 year-old
Requiring long-term care score 4 or 5
Person who need diaper for excretion
Person who take stimulant laxatives every day but can stop it
Person who can eat in a wheelchair and has a hip range of motion of 90 degrees or more
Key exclusion criteria
Person who have had a history of colorectal surgery
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Toshie |
| Middle name | |
| Last name | Tsuchida |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima Chuo-ku Kobe Hyougo
TEL
0783043125
tsuchida@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Tsuchida |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima Chuo-ku Kobe Hyougo
TEL
0783043125
Homepage URL
tsuchida@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-3-6 Minatojima Chuo-ku Kobe Hyogo
Tel
0783043125
tsuchida@hyo-med.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
グルメ杵屋社会貢献の家
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044877
| 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 |
