UMIN-CTR Clinical Trial

Basic information
Public title	Survey for nurses'burden feeling to defecation management for dementia patients with chronic constipation before and after elobixibat introduction
Acronym	Survey for nurses'burden feeling to defecation management for dementia patients with chronic constipation before and after elobixibat introduction
Scientific Title	Survey for nurses'burden feeling to defecation management for dementia patients with chronic constipation before and after elobixibat introduction
Scientific Title:Acronym	Survey for nurses'burden feeling to defecation management for dementia patients with chronic constipation before and after elobixibat introduction
Region	Japan

Condition
Condition	Dementia patients with chronic constipation
Classification by specialty	Hepato-biliary-pancreatic medicine Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we research how the nurses' burden feelings to defecation management for dementia patients with chronic constipation changes by using eroxibat
Basic objectives2	Others
Basic objectives -Others	Nursing Research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of nurses' burden feeling to defection management before and after elobixibat introduction each for patients who go to the restroom by themselves and bedridden patents
Key secondary outcomes	Evaluations for each questions in the questionnaire. The prescription situation of the enema in fifth ward.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Nurses who have worked in the fifth ward as the ward for dementia patients on September 2019. Nurses who agreed that one can answer the questionnaire.
Key exclusion criteria	Nurses who have no experience to defection management of patients using elobixibat. Nurses who have no experience to defection management of constipation patients before elobixibat introduction.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Mayumi Middle name Last name Fukuhara
Organization	MATSUGAOKA HOSPITAL
Division name	Nursing Dept.
Zip code	698-0041
Address	4-24-10 Takatsu Masuda City,Shimane
TEL	0856-22-8730
Email	matugaoka@matugaoka-iatria.jp

Public contact
Name of contact person	1st name Minami Middle name Last name Umeyama
Organization	EA Pharma Co.,Ltd.
Division name	Medical Dept.
Zip code	104-0042
Address	2-1-1 Irifune Chuo-ku,Tokyo
TEL	03-6280-9814
Homepage URL
Email	minami_umeyama@eapharma.co.jp

Sponsor
Institute	EA Pharma Co.,Ltd.
Institute
Department

Funding Source
Organization	EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yamauchi Clinic IRB
Address	1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel	03-6777-1490
Email	c-irb_ug@neues.co.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	2021 Year 08 Month 06 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	17
Results	The burden of nurses decreased to 62.9% in "patients who can go to the toilet by themselves" and to 73.8% in "bedridden patients" after the introduction of elobixibat, indicating a significant decrease in the burden of nurses in both groups (p<0.001). The main reason for the change in burden was a decrease in the frequency of enemas.
Results date posted	2022 Year 04 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The mean and median nursing experience was 18.4 and 15.0 years, respectively, and the majority of the nurses were skilled nurses with a great deal of clinical experience. The 7.7 hours of nursing work per day were spent on average. Of the average 14.4 patients with chronic constipation for whom nurses were responsible, 7.6 patients were able to go to the toilet on their own and 6.7 patients were bedridden.
Participant flow
Adverse events
Outcome measures	(1)Changes in time of defecation management After the introduction of elobixibat, the number of patients who could go to the toilet by themselves decreased by 7.7 minutes, a significant decrease (p<0.001), while the number of patients who were bedridden decreased by 7.5 minutes, but the difference was not significant. (2)Results of the number of enemas performed in dementia treatment wards The number of enemas per nurse decreased from 5.5/month before the introduction of Elobixibat to 3.9/month after the introduction (p<0.001) during the January-August period.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 05 Month 31 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 08 Month 10 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry	2021 Year 09 Month 16 Day
Date trial data considered complete	2021 Year 09 Month 16 Day
Date analysis concluded	2021 Year 11 Month 30 Day

Other
Other related information	None

Management information
Registered date	2021 Year 08 Month 03 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051447