UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031311 |
|---|---|
| Receipt number | R000035622 |
| Scientific Title | Randomized comparative study on feasibility of electronic version of the Pediatric Quality of Life Inventory (ePedsQL) |
| Date of disclosure of the study information | 2018/02/19 |
| Last modified on | 2021/02/16 11:03:15 |
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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
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
satoi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035622
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
