UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053161 |
|---|---|
| Receipt number | R000060476 |
| Scientific Title | Effects of a receiprocal care promotion program on engagement and psychological distress: a randomized controlled trial. |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2024/12/19 00:09:27 |
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Basic information
Public title
Effects of a receiprocal care promotion program on engagement and psychological distress: a randomized controlled trial.
Acronym
Effects of a receiprocal care promotion program on engagement and psychological distress: a randomized controlled trial.
Scientific Title
Effects of a receiprocal care promotion program on engagement and psychological distress: a randomized controlled trial.
Scientific Title:Acronym
Effects of a receiprocal care promotion program on engagement and psychological distress: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Nothing in particular (Not targeting specific diseases. Targeting general workers.)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the impact of a new program designed to promote mutual assistance in the workplace on the mental health of workers in their twenties, using a randomized controlled trial design."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Engagement, psychological stress response.
Key secondary outcomes
isolation, presenteeism, psychological capital (hope, self-efficacy, resilience, optimism), support from supervisors/colleagues, and program satisfaction and usefulness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participation in a 3-week mutual assistance program with three key elements: 1. Care Receivers, 2. Care Givers, and 3. Short Talks. All workers registered in the program become potential Care Receivers. Care Receivers can refer to the list of registered Care Givers and request a Short Talk from any individual at any time. On the other hand, Care Givers actively register with the consent of participants. After registration, Care Givers update information in the Care Giver list and accept Short Talk requests from Care Receivers during the program period. Care Givers can also become Care Receivers and request Short Talks from other Care Givers. A Short Talk involves an about 30-minute conversation between a Care Receiver and a Care Giver, primarily conducted online."
Interventions/Control_2
No intervention. Effect measurements are conducted at the same timing as the intervention group, with no actual intervention taking place.
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Affiliation with a company, aged 20 or older but less than 30, and consenting to participate in the study. To calculate the target sample size using Gpower 3.1.9.7, set at 185 participants for each group, with an effect size based on previous research of 0.24, a significance level (alpha error) of 5%, and a power (1-beta error) of 90%.
Key exclusion criteria
None
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Komase |
Organization
Fujitsu Japan Ltd.
Division name
Healthcare Cloud Services Division
Zip code
212-0014
Address
JR Kawasaki Tower, 1-5 Omiya-cho, Saiwai-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-330-9842
komase.yu@jp.fujitsu.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Komase |
Organization
Fujitsu Japan Ltd.
Division name
Healthcare Cloud Services Division
Zip code
212-0014
Address
JR Kawasaki Tower, 1-5 Omiya-cho, Saiwai-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-330-9842
Homepage URL
komase.yu@jp.fujitsu.com
Sponsor or person
Institute
Fujitsu Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
None.
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
N / A
Address
N / A
Tel
N / A
N / A
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
| 2023 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
79
Results
The following outcome showed a significant trend towards improvement in the intervention group at T2:
Optimism (p=0.077)
The following outcomes showed a significant trend or significant improvement in the intervention group at T3:
Optimism (p=0.084)
Psychological capital (p=0.030)
Absenteeism (p=0.038)
The other outcomes showed no significant effect at T2 and T3.
Results date posted
| 2024 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 24 | Day |
Baseline Characteristics
The participants were full-time employees in their 20s working for private companies in Japan. Participants were included based on their self-selection in response to the recruitment. There were no exclusion criteria.
Participant flow
Following baseline data collection (T1), participants were randomly assigned to either an intervention or a control group. The intervention group received a three-week program. A second survey (T2) was conducted upon completion of the intervention program. A follow-up survey (T3) was conducted four weeks after T2.
Adverse events
Not confirmed
Outcome measures
Engagement
Psychological stress response
Isolation/loneliness
Well-being
Presenteeism
Hope
Self-efficacy
Resilience
Optimism
Psychological capital
Absenteeism
Supervisor support
Peer support
Protocol Amendment
Absenteeism was added to the study at the request of the HR department personnel involved in the study, due to their expressed interest in this variable.
Plan to share IPD
No schedule
IPD sharing Plan description
No schedule
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060476
