UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029096 |
|---|---|
| Receipt number | R000033017 |
| Scientific Title | Validitiy and reliability of TRAQ(Transition Readiness Assessment Questionnaire) Japanese version |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2020/09/13 13:13:37 |
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Basic information
Public title
Validitiy and reliability of TRAQ(Transition Readiness Assessment Questionnaire) Japanese version
Acronym
Validitiy and reliability of TRAQ(Transition Readiness Assessment Questionnaire) Japanese version
Scientific Title
Validitiy and reliability of TRAQ(Transition Readiness Assessment Questionnaire) Japanese version
Scientific Title:Acronym
Validitiy and reliability of TRAQ(Transition Readiness Assessment Questionnaire) Japanese version
Region
| Japan |
Condition
Condition
Chronic diseases which developed in the childhood, and are in need of continuous treatment or follow-up, even after adulthood.(chronic kidney disease, rheumatic disease, diabetes, chronic heart disease etc)
Classification by specialty
| Pediatrics | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the validity and reliability of TRAQ (Transition Readiness Assessment Questionnaire) Japanese vesrion.
Basic objectives2
Others
Basic objectives -Others
Validaion of scale
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity and reliability of TRAQ Japanese version
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who
(1)is 16-20 years old
(2)developed chronic diseases in their childhood, and are in need of continuous treatment or follow-up, even after they reach the age of adulthood (chronic kidney disease, rheumatic disease, diabetes, chronic heart disease etc)
(3)can answer to the quetionnaire by him/herself.
(4)agreed to participate in this study
Key exclusion criteria
The patient who
(1)didn't agree to participate in this study
(2)has difficulty in communication in Japanese
(3)is difficult to answer to the questionnaire by him/herself because of mental retardation
(4)is judged inappropriate to participate in the study by doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nakayama |
Organization
Kyoto University
Division name
Department of Health Informatics, School of Public Healt
Zip code
606-8501
Address
Konoe-cho, Sakyo-ku, City of Kyoto, Kyoto Prefecture, Japan
TEL
075-753-9479
nakayama.takeo.4a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Kyoto University
Division name
Department of Health Informatics, School of Public Healt
Zip code
606-8501
Address
Konoe-cho, Sakyo-ku, City of Kyoto, Kyoto Prefecture, Japan
TEL
075-753-9479
Homepage URL
nakayama.takeo.4a@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate school and Faculty of Medicine, Ethics Comittee
Address
Konoe-cho, Sakyo-ku, City of Kyoto, Kyoto Prefecture, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
東京女子医科大学病院（東京都）、東京医科歯科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033017
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31820509/
Number of participants that the trial has enrolled
107
Results
Cronbach's alpha coefficients were 0.94 overall and 0.9-0.06 for each of the four domains.
The known-group analysis revealed that older participants(r=0.23, p=0.044), those having knowledge of the disease name (yes[4.0] vs no[3.4]; p<0.001), and making unaccompanied hospital visits (with parents/others[3.7 vs alne[4.4]; p<0.001) had significantly higher total TRAQ scores. We confirmed preliminarily the validity and reliability of the Japanese TRAQ.
Results date posted
| 2020 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender Male 40, Female 36
Age Male 17.8, Female 18.2
main disease
Kidney 32, heart 26, Others 18
Participant flow
The self-administered survey was conducted in a face-to-face
fashion at pediatric nephrology, pediatric rheumatology, and general
pediatric outpatient departments of two university hospitals,
or by mail for those belonging to the Patient Association for Congenital
Heart Disease. Researchers were requested by medical
staff to provide participants with an explanation of the survey,
and those who provided consent were given the explanation in a
waiting room after their medical examination. Participant consent
was obtained verbally and was indicated on the questionnaire
with a check mark. Participants completed the questionnaire on
the spot, or if inconvenient, the form was mailed to them at a
later date. If the mail method was used, a form explaining how to
fill out the survey was provided along with the survey form. Participants
were asked to fill out the form after reading the explanation
and to send it back using an enclosed return envelope.
Adverse events
None
Outcome measures
Japanese TRAQ score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2020 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033017
| Research Plan | |
|---|---|
| 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 |
