UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053557 |
|---|---|
| Receipt number | R000054776 |
| Scientific Title | Development and effectiveness of a workplace support program to promote the retention of care workers in geriatric care facilities |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/08 14:02:37 |
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Basic information
Public title
Development and effectiveness of an educational program to foster psychological safety: a randomized control trial focusing on care workers in geriatric care facilities
Acronym
Development and effectiveness of a workplace support program in geriatric care facilities
Scientific Title
Development and effectiveness of a workplace support program to promote the retention of care workers in geriatric care facilities
Scientific Title:Acronym
Development and effectiveness of a workplace support program in geriatric care facilities
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate the effectiveness of a workplace support program to resolve issues in the work environment, including human relationship, in geriatric care facilities, which are key to supporting the elderly care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological safety
The score of baseline, after 2 montsh, and after 4 months among participants in a intervention group will be compared to the scores in a control group.
Key secondary outcomes
The Social Capital and the Ethical Climate in the Workplace (three subscales: social capital in the workplace, ethical leadership, exclusive workplace climate)
Work orientation
Intentions to leave
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
For fostering a healthy work environment with psychological safety, we develop the program using the case method, which uses case studies from the field as teaching materials and requires participants to actively exchange opinions in each group. The program is a 60-minute class consisting of six modules geared towards effective discussions on keeping psychological safety in the workplace: guidance and lecture, two 3-minutes videos being made based on original episodes of interpersonal and transcultural issues at the workplace in geriatric healthcare facilities, individual work, group work, presentation, and reflection. The participants in the intervention group will be required to attend two intervention programs in four months.
Interventions/Control_2
Participants will complete three questionnaire surveys (baseline, and two follow-up surveys: two months and four months after baseline survey) in six months.
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
Persons who have agreed to participate in this study and who are able to attend the training sessions, at facilities that have agreed to cooperate in the research.
Key exclusion criteria
Those who could not give their consent, or those who are unable to attend the workshop (due to work shift or other reasons).
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Maki |
| Middle name | |
| Last name | Tei-Tominaga |
Organization
Setsunan University
Division name
Faculty of Nursing
Zip code
573-0101
Address
45-1, Nagao Toge-cho, Hirakata city, Osaka, Japan
TEL
0728001238
maki.tominaga@nrs.setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Tei-tominaga |
Organization
Setsunan University
Division name
Faculty of Nursing
Zip code
573-0101
Address
45-1, Nagao Toge-cho, Hirakata city, Osaka, Japan
TEL
0728001238
Homepage URL
maki.tominaga@nrs.setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Mitsui Sumitomo Insurance Welfare Foundation
IRB Contact (For public release)
Organization
Setsunan University
Address
45-1, Nagao Toge-cho, Hirakata city, Osaka
Tel
0728001238
maki.tominaga@nrs.setsunan.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
| 2024 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
192
Results
The psychological safety score significantly increased (p < .05) and the exclusive workplace climate score decreased (p < .10) from the baseline (T0) to second survey (T1) among the intervention group compared to control group. However, in the significance of the scores' change of the intervention group has vanished from the baseline (T0) to third survey (T2) (Table 3).
Results date posted
| 2024 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was in the 40s for both groups, with more than 75% of the participants being woman and more than 50% unmarried. There were no significant differences between the two groups in terms of years of experience in care work for older adults or years of working at current provider. On the other hand, there was a significant difference between the two groups in employment status, while ratio on regular employees in the intervention group (98.9%) was significantly higher than that in the control group (78.5%), (p < .001). In addition, 65.6% of the intervention group were professional caregivers compared to 57% of the control group, a significant difference (p < .05).
Participant flow
The first time intervention was held with a face to face. The second-time intervention was held with online due to expanding the infected people of COVID-19 in Japan. After attending each intervention, the participants in the intervention group were asked not to talk to members at their workplace about contents of the programs. The participants in the control group received the program's materials of the first and second time interventions from the contact persons in each facility. All participants were asked to complete self-reported questionnaires given by contact persons three times in six months.
Adverse events
Outcome measures
As a primary outcome, question items of a scale for psychological safety were addressed as well as secondary outcomes, which are assessment tools for intrinsic motivation, intentions to leave, and work environment including human relationships of care workers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054776
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
