UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the Effectiveness of a web-based job crafting application on work engagement: A Randomized Controlled Trial
Acronym	Evaluation of the Effectiveness of a web-based job crafting application on work engagement: A Randomized Controlled Trial
Scientific Title	Evaluation of the Effectiveness of a web-based job crafting application on work engagement: A Randomized Controlled Trial
Scientific Title:Acronym	Evaluation of the Effectiveness of a web-based job crafting application on work engagement: A Randomized Controlled Trial
Region	Japan

Condition
Condition	Working persons
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effectiveness of a web-based job crafting application for improving work engagement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Work engagement
Key secondary outcomes	Quantitative job overload (pre, post, 4-week follow-up) Qualitative job overload (pre, post, 4-week follow-up) Physical demands (pre, post, 4-week follow-up) Job control (pre, post, 4-week follow-up) Suitable jobs (pre, post, 4-week follow-up) Supervisor support (pre, post, 4-week follow-up) Coworker support (pre, post, 4-week follow-up) Workplace social capital (pre, post, 4-week follow-up) Job crafting (pre, post, 4-week follow-up) Intrinsic rewards (pre, post, 4-week follow-up) Psychological distress (pre, post, 4-week follow-up) Creative behavior (pre, post, 4-week follow-up) Job satisfaction (pre, post, 4-week follow-up) Life satisfaction (pre, post, 4-week follow-up) Program use satisfaction(post) Amount of the program(post) Needs of the program(post) Feasibility of the program(post) Subjective effectiveness of the program(post, 4-week follow-up) Degree of progress of the program(post, 4-week follow-up)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Participants who assigned to the intervention group will engage a web-based job crafting application to improve work engagement for one month.
Interventions/Control_2	Participants who were assigned to wait list control group will spend usual days during intervention period. They take the same program as those in the intervention group after intervention period.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	A personal computer (PC) connected to the Internet must be available. Company has agreed to allow participants to use the web application during their working hours.
Key exclusion criteria	Nothing
Target sample size	1367

Research contact person
Name of lead principal investigator	1st name Akihito Middle name Last name Shimazu
Organization	Keio University
Division name	Faculty of Policy Management
Zip code	252-0882
Address	5322 Endo, Fujisawa-city, Kanagawa, Japan
TEL	0466493638
Email	ashimazu-tky@umin.ac.jp

Public contact
Name of contact person	1st name Akihito Middle name Last name Shimazu
Organization	Keio University
Division name	Faculty of Policy Management
Zip code	252-0882
Address	5322 Endo, Fujisawa-city, Kanagawa, Japan
TEL	0466493638
Homepage URL
Email	ashimazu-tky@umin.ac.jp

Sponsor
Institute	Faculty of Policy Management, Keio University
Institute
Department

Funding Source
Organization	Hitachi Solutions, Ltd
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	Experiment and Research Ethics Committee, Faculty of Policy Management, Faculty of Environment and Information Studies, Graduate School of Media and Governance, Keio University.
Address	5322 Endo, Fujisawa-city, Kanagawa, Japan
Tel	0466493404
Email	somu@sfc.keio.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	慶應義塾大学（神奈川県），株式会社 日立ソリューションズ (東京都)，東京女子医科大学(東京都)，就実大学(岡山県) / Keio University (Kanagawa)，itachi Solutions, Ltd (Tokyo), Tokyo Women’s Medical University (Tokyo), Shujitsu University (Okayama)

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 26 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	165
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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 11 Month 15 Day
Date of IRB	2020 Year 12 Month 15 Day
Anticipated trial start date	2021 Year 01 Month 25 Day
Last follow-up date	2021 Year 05 Month 10 Day
Date of closure to data entry	2021 Year 05 Month 31 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 26 Day
Last modified on	2021 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049947