UMIN-ICDS Clinical Trial

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

Nothing in particular (Not targeting specific diseases. Targeting general workers.)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

komase.yu@jp.fujitsu.com

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

Email

komase.yu@jp.fujitsu.com

Institute

Fujitsu Japan Ltd.

Institute

Department

Personal name

Organization

None.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N / A

Address

N / A

Tel

N / A

Email

N / A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

25

Day

Date of IRB

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 related information

Registered date

2023

Year

12

Month

19

Day

Last modified on

2023

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060476