UMIN-CTR Clinical Trial

Basic information
Public title	The association between team job crafting and work engagement among nurses: prospective cohort study
Acronym	The association between team job crafting and work engagement among nurses: prospective cohort study
Scientific Title	The association between team job crafting and work engagement among nurses: prospective cohort study
Scientific Title:Acronym	The association between team job crafting and work engagement among nurses: prospective cohort study
Region	Japan

Condition
Condition	N/A
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the association between team job crafting and work engagement among nurses through three- and six-month follow-ups. This study investigates the following hypotheses. 1) Group (ward)-level team job crafting scores* at T1 (baseline) is positively associated with individual-level work engagement scores at T2 (three months later) and T3 (six months later). 2) Group-level subgroup analysis (using quartile scores) by workplace social capital and psychological safety: The association between group-level team job crafting at T1 and individual-level work engagement at T2 and T3 is greater for higher workplace social capital or psychological safety than lower. If the association cannot be verified at the group level, we will analyze the individual-level association. 3) Individual-level team job crafting at T1 is positively associated with individual-level work engagement at T2 and T3. Note 1)~3) analyses adjust for gender, age, education, experience years, marital status, T1 work engagement, demand, control, supervisor/coworker support, effort/reward imbalance, and individual-level team job crafting. Secondary outcomes: 4) Group-level team job crafting at T1 is positively associated with individual-level WHO-HPQ at T2 and T3 and negatively associated with K6 and intention to leave scores at T2 and T3. Note 4) analysis adjusts for gender, age, education, experience years, marital status, T1 secondary outcome scores (WHO-HPQ; K6; intention to leave), demand, control, supervisor/coworker support, effort/reward imbalance, and individual-level team job crafting. *Calculation of the team job crafting score. -Individual-level: a mean score of the three subscales (mean) and mean scores of each three subscales (sub1), (sub 2), and (sub 3) are calculated and group-mean centered. -Group-level: The mean score for each of the individual-level team job crafting scores (mean), (sub 1), (sub 2), and (sub 3) are calculated, and grand-mean centered.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Work engagement: Japanese version of Utrecht Work Engagement Scale (Shimazu et al., 2008)
Key secondary outcomes	-Team job crafting: Team job crafting scale for nurses (Iida et al., 2020) -Work performance; WHO-HPQ (Kawakami et al., 2020) -Psychological distress: Kessler's Psychological Distress Scale (K6) (Furukawa et al., 2008) -Intention to leave: Japanese version of the four-item scale used in the study of Geruts et al (Tsuno et al., 2017)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Those who are more than 18 years old. 2) Nurses, associate nurses, or midwives who belong to the wards in a hospital.
Key exclusion criteria	N/A
Target sample size	2277

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Miyamoto
Organization	The University of Tokyo
Division name	Graduate School of Medicine, Department of Psychiatric Nursing
Zip code	1130033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3364
Email	yyuki@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Mako Middle name Last name Iida
Organization	The University of Tokyo
Division name	Graduate School of Medicine, Department of Psychiatric Nursing
Zip code	1130033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3364
Homepage URL
Email	idamako@m.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Other
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(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5841-0818
Email	03-5841-0818

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	2022 Year 05 Month 22 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
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	Enrolling by invitation
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 22 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study investigates the association between team job crafting and work engagement among nurses by prospective cohort design.

Management information
Registered date	2022 Year 05 Month 20 Day
Last modified on	2022 Year 05 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054282

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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