UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031831 |
|---|---|
| Receipt number | R000036353 |
| Scientific Title | The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/04/01 20:33:25 |
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Basic information
Public title
The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Acronym
The effects of intervention using case conferences on staff well-being in long-term care hospitals.
Scientific Title
The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Scientific Title:Acronym
The effects of intervention using case conferences on staff well-being in long-term care hospitals.
Region
| Japan |
Condition
Condition
Mental health
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct the intervention using case conferences and evaluate its effects on the mental health among nurses and care workers working in long-term care hospitals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Burnout will be measured by the 17- item Japanese Burnout scale. Work engagement will be measured by the Japanese short version of the Utrecht work engagement scale.
We will conduct self-administered, anonymous questionnaire surveys four times: before the intervention (Baseline: Time 0), 3 months after the intervention (Time 1), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).
Key secondary outcomes
The perception of support from nursing managers and colleagues, care quality in their ward and job demands.Furthermore, physical restraint, urinary tract infection, incidence of pressure ulcer, number of patients who fell down and so on.
In addition to questionnaire surveys, We will conduct chart review: before the intervention (Baseline: Time 0), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This intervention will consist of monthly,60-minute sessions, for a total of 6 months.
Course A
Receive intervention using case conferences first(Intervention group).
Interventions/Control_2
Course B
Receive intervention in the later phase (Control group).
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 and care workers working in the long-term care hospitals.
Key exclusion criteria
Nurses and care workers who decline in the participation of this study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Yamamoto-Mitani |
Organization
The University of Tokyo
Graduate School of Medicine
School of Health Sciences and Nursing
Division name
Department of Gerontological Home-Care & Long-term Care Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL
03-5841-3508
noriko-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo Graduate School of Medicine School of Health Sciences and Nursing
Division name
Department of Gerontological Home-Care & Long-term Care Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL
03-5841-3508
Homepage URL
syumiko-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gerontological Home-Care & Long-term Care Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Nippon Life Insurance Foundation and
the Univers Foundation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 04 | 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
| Delay expected |
Results Delay Reason
From April 2018 to March 2019, we conducted an intervention using case conferences for nurses and care workers in nine long-term care hospitals (five intervention groups and four control groups). After the implementation of the intervention, we conducted questionnaires and medical record surveys to verify the effectiveness of the intervention. We completely collected data through questionnaires and medical record surveys without any problems, and the data is currently being analyzed.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Not applicable
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 21 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036353
