UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051630 |
|---|---|
| Receipt number | R000058916 |
| Scientific Title | Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2024/07/26 14:06:17 |
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Basic information
Public title
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Acronym
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title:Acronym
Attrition and adherence in digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Mental Health
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine attrition and adherence rates in interventions using digital health technology as primary prevention of mental health outcomes among workers, by intervention content and participant characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
attrition and adherence
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
- Studies including any type of employees/workers as "population"
- Studies applying any type of non-pharmacological interventions aiming at primary prevention using digital health technologies (eg., exercises, diet, lifestyle, psychological intervention such as cognitive behavioral therapy) as "intervention"
- Studies applying any type of control conditions as "comparison"
- Studies assessing effectiveness using specific outcomes including mental health conditions, positive mental health, and work-related outcomes as "outcomes"
- Studies addressed information on attrition and/or adherence
- Studies using randomized controlled trial design
- Studies published after 2010
Key exclusion criteria
- Studies targeting participants who have any specific disorder.
- Studies including participants who are not employees/workers.
- Studies applying any type of interventions aiming at secondary or tertiary prevention.
- Studies aiming to evaluate treatment effects of interventions on specific disorders or symptoms
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Kanamori |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211(46215)
satoru_kanamori@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Kanamori |
Organization
Teikyo University
Division name
Graduate School of Public Health
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211(46215)
Homepage URL
satoru_kanamori@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University, Graduate School of Public Health, Satoru Kanamori
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Medical Research Ethics Committee
Address
2-11-1 Kaga Itabashi-ku, Tokyo, Japan
Tel
03-3964-7256(42203)
turb-office@teikyo-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 18 | 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
146
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
1) Identified records: database (n=37851)
Records excluded before the screening:
Records marked as ineligible
marked as ineligible by automated tools (n=515)
Records excluded for other reasons (limited to 2010 and later) (n=3275)
2) Screened records (n=19091)
Of which, reports removed (n=18806)
3) Reports sought to obtain (n=285)
Of which, reports removed (n=139)
4) Total studies adopted for review (n=146)
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on a synthesis of randomized controlled trials, this systematic review and meta-analysis examine dropout and compliance rates in interventions using digital health technology as primary prevention of mental health outcomes in workers, by intervention content and subject characteristics.
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058916
