UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045048 |
|---|---|
| Receipt number | R000051447 |
| Scientific Title | Survey for nurses'burden feeling to defecation management for dementia patients with chronic constipation before and after elobixibat introduction |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2022/04/11 11:23:03 |
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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
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
minami_umeyama@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051447
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