UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048567 |
|---|---|
| Receipt number | R000055336 |
| Scientific Title | Opinion survey on the current situation and problems with dialysis therapy in nurses-Questionnaire study- |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2024/02/14 16:19:52 |
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Basic information
Public title
Opinion survey on the current situation and problems with dialysis therapy in nurses-Questionnaire study-
Acronym
Opinion survey on the current situation and problems with dialysis therapy in nurses-Questionnaire study-
Scientific Title
Opinion survey on the current situation and problems with dialysis therapy in nurses-Questionnaire study-
Scientific Title:Acronym
Opinion survey on the current situation and problems with dialysis therapy in nurses-Questionnaire study-
Region
| Japan |
Condition
Condition
maintenance hemodialysis
Classification by specialty
| Nephrology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the current situation and problems with dialysis therapy in nurses who work at dialysis facilities.
Basic objectives2
Others
Basic objectives -Others
opinion survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) The current situation and problems in building the trusting relationship between nurse and patient
2) The current situation and problems with medication burden
3) How to engage in maintenance hemodialysis therapy on nurses
Key secondary outcomes
Base
Study type
Observational
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
1) Nurses and Associate Nurses who provide Web consent themselves
2) Nurses and Associate Nurses who engage in maintenance hemodialysis therapy
Key exclusion criteria
1) Nurses and Associate Nurses who engage in maintenance hemodialysis therapy for less than one year
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kawashima |
Organization
Ono Pharmaceutical CO, LTD
Division name
Primary Medical , Medical Affairs
Zip code
541-8564
Address
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
TEL
06-6263-5670
m.kawashima@ono-pharma.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Oba |
Organization
SMS Co.,Ltd.
Division name
None
Zip code
105-0011
Address
11-1, shibakoen 2-chome, minato-ku, Tokyo
TEL
03-6721-2400
Homepage URL
survey@nurse-senka.jp
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
Tel
06-6263-2992
n.nishiwaki@ono.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
| 2022 | Year | 08 | Month | 10 | 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
443
Results
1) Patient trust relationship level: 60/100; Trust deterioration experience 79% (causes: cannulation 49%, daily life interview 35%)
2) Consideration level of patient medication burden: 50/100; Means to reduce burden: patient's understanding of drug efficacy 28%, prioritizing injectable drugs 25%
3) Workload burden during dialysis [time-related] daily life inquiries 54%, [mental] dietary guidance 51%. Workload burden pre- and post-dialysis [time-related] cannulation 49%, [mental] cannulation 63%
Results date posted
| 2024 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average Age43.7 SD8.7 years
Gender Female/Male/Other 414/26/3
Position Management/General 86/357
Average Nursing Experience17.7 SD9.2 years
Average Dialysis Work Experience9.8 SD7.1 years
Workplace University Hospital/Public Hospital/Private Hospital/Clinic/Other 23/42/225/152/1
Participant flow
This survey was conducted for registered nurses and licensed practical nurses who are members of the nursing portal site "Nurse Senka" operated by SMS Co., Ltd. The survey was sent via email to nurses and licensed practical nurses who have registered their specialty as "dialysis" and have at least "1 year" of experience. The participants were provided with an introductory document and consent form on the web survey screen, and those who agreed proceeded to answer the web survey. The survey was conducted from August to September 2022.
Adverse events
-
Outcome measures
1) Current Status and Challenges in Building Trust Relationships with Patients
2) Current Status and Challenges in Reducing Patient Medication Burden
3) Involvement in Dialysis Work
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 26 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055336
| Research Plan | |
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| Registered date | File name |
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