UMIN-CTR Clinical Trial

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