UMIN-CTR Clinical Trial

Basic information
Public title	Randomized comparative study on feasibility of electronic version of the Pediatric Quality of Life Inventory (ePedsQL)
Acronym	Development of ePedsQL
Scientific Title	Randomized comparative study on feasibility of electronic version of the Pediatric Quality of Life Inventory (ePedsQL)
Scientific Title:Acronym	Development of ePedsQL
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Not applicable Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare psychometric properties and feasibility of ePedsQL between paper-like format and another format optimized for smartphone.
Basic objectives2	Others
Basic objectives -Others	feasibility
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Item response rate
Key secondary outcomes	Scale response rate Effective response rate Response time required Summary statistics Factor structure (Measurement and structural invariance)

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	1 months-old <=
Age-upper limit	216 months-old >=
Gender	Male and Female
Key inclusion criteria	Parents (first and second caregiver) of children aged between 1-month and 18-year Children aged between 5 to 18 years
Key exclusion criteria	Persons who cannot answer to ePedsQL because of their visual or intellectural dysfunction
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Iori Middle name Last name Sato
Organization	The University of Tokyo
Division name	Department of Family Nursing
Zip code	1130033
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL	03-5841-3694
Email	satoi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Iori Middle name Last name Sato
Organization	The University of Tokyo
Division name	Department of Family Nursing
Zip code	1130033
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL	03-5841-3694
Homepage URL
Email	satoi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology - Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address	Hongo 7-3-1, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.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	2018 Year 02 Month 19 Day

Related information
URL releasing protocol	https://dx.doi.org/10.1186%2Fs41687-020-00213-w
Publication of results	Published

Result
URL related to results and publications	https://dx.doi.org/10.1186%2Fs41687-020-00213-w
Number of participants that the trial has enrolled	9092
Results	We found that the non-response alert lowered the item non-response rate. The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit.
Results date posted	2021 Year 02 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	https://dx.doi.org/10.1186%2Fs41687-020-00213-w
Participant flow	https://dx.doi.org/10.1186%2Fs41687-020-00213-w
Adverse events	No
Outcome measures	https://dx.doi.org/10.1186%2Fs41687-020-00213-w
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 02 Month 19 Day
Date of IRB	2018 Year 02 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 20 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	Parallel Randomized Individual Open - but assessor(s) are blinded Control - Active Stratification by age and recruited source Blocking

Management information
Registered date	2018 Year 02 Month 15 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035622