UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053157 |
|---|---|
| Receipt number | R000060636 |
| Scientific Title | Effects of a smartphone-based social support intervention program: A pretest-and-posttest study |
| Date of disclosure of the study information | 2023/12/19 |
| Last modified on | 2023/12/19 13:58:19 |
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Basic information
Public title
Effects of a smartphone-based social support intervention program: A pretest-and-posttest study
Acronym
Effects of a smartphone-based social support intervention program: A pretest-and-posttest study
Scientific Title
Effects of a smartphone-based social support intervention program: A pretest-and-posttest study
Scientific Title:Acronym
Effects of a smartphone-based social support intervention program: A pretest-and-posttest study
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 effects of a smartphone-based positive refleciton application for enhancing work engagement among workers.
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
General self-efficacy
Self-esteem
Psychological distress
Job performance
Job satisfaction
Life satisfaciton
Supervisor support
Coworker support
Coping profile for workers
Workplace where people compliment each other
Quantitative job overload
Qualitative job overload
Physical demands
Job control
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants are required to use the positive reflection web app at work for two weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for participants were as follows: (1) being employees including official servants, (2) being employed by an organization with a minimum of 300 employees, (3) aged 20 to under 60, (4) working on weekdays, and (5) working full-time (excluding shortened hours working or childcare leave).
Key exclusion criteria
The exclusion criteria for participants were as follows: (1) using shortened hours working and (2)using childcare leave.
Target sample size
100
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
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
ashimazu-tky@umin.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Other(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
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）/ Keio University (Tokyo),
株式会社日立ソリューションズ（東京都） / Hitachi Solutions, Ltd(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 19 | 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
125
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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical trial registry for the study was a post-enrollment registry.
Management 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/ctr_e/ctr_view.cgi?recptno=R000060636
