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Recruitment status Completed
Unique ID issued by UMIN UMIN000029096
Receipt No. 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

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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
Email 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
Email nakayama.takeo.4a@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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