UMIN-ICDS 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 2023/07/18 09:50:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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)

Email

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


Email

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)

Email

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


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

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

2023 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058916


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name