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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040903
Receipt No. 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 2020/06/25

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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
Email 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
Email t-naito@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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 Preinitiation
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 03 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
2020 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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