UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040903 |
|---|---|
| Receipt number | R000046647 |
| Scientific Title | Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia, and evaluation of feasibility of defecation care practice by care staff. |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2021/11/02 19:08:04 |
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Basic information
Public title
Effects of bowel training and rational defecation posture on chronic constipation in elderly people with dementia.
Acronym
Effect of defecation care on constipation in the elderly with dementia.
Scientific Title
Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia, and evaluation of feasibility of defecation care practice by care staff.
Scientific Title:Acronym
Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia.
Region
| Japan |
Condition
Condition
Chronic constipation diadnosed by Rome IV criteria
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of bowel training combined with rational bowel posture on chronic functional constipation in elderly people with dementia.
As a secondary study, we aim to examine the feasibility of defecation care by the care staff.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monthly responder rates and weekly changes from baseline in complete spontaneous bowel movement.
Monthly responder rates and weekly changes from the baseline in spontaneous bowel movement.
Key secondary outcomes
1 The patient's assessment of constipation quality of life (JPAC-QOL)
2 Constipation Scoring System(CSS)
3 Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
4 Change in laxative dose required.
5 Overall care efficacy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Defecation care that combines bowel training and a rational defecation posture
Interventions/Control_2
Defecation care within the scope of normal 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Diagnosis according to the Rome 4 criteria
2.Diagnosis of dementia or daily living independence degree of demented elderly of 2 or more
3.Elderly people who keep sitting in the toilet.
4.Elderly people capable of daily conversation.
Key exclusion criteria
1.Colostomy
2.Tube feeding
3.Secondary constipation
4.Those judged ineligible to participate in the research by the doctor in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2511
t-naito@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2511
Homepage URL
t-naito@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
Tel
053-435-2511
t-naito@hama-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | 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
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046647
