UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020745 |
|---|---|
| Receipt number | R000023944 |
| Scientific Title | Construction of the medical information system which aims education and total life care for patients with congenital heart diseases. |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2023/05/15 13:49:41 |
* 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
Construction of the medical information system which aims education and total life care for patients with congenital heart diseases.
Acronym
A study on the physical, psychological and social problems in adolescence with congenital heart diseases.
Scientific Title
Construction of the medical information system which aims education and total life care for patients with congenital heart diseases.
Scientific Title:Acronym
A study on the physical, psychological and social problems in adolescence with congenital heart diseases.
Region
| Japan |
Condition
Condition
Adolescence with congenital heart diseases and their family
Classification by specialty
| Cardiology | Pediatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify physical, psychological and social problems in adolescence with congenital heart diseases and their family.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The physical, psychological and social problems in patients with congenital heart diseases, and the psychological and social problems in their family
Key secondary outcomes
The relationships among physical, psychological, and social problems in adolescence with congenital heart diseases
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1) Patients diagnosed congenital heart diseases with /without treatments.
2) 16 years old or over
3) Patients who can proceed informed consent (If the patients was under 18 years old, we will obtain informed consent from their family)
Family
1) The family who is supporting the patient.
2) Family who can proceed informed consent
Key exclusion criteria
Patient
1) Patient with severe diseases except for congenital heart diseases
Family
1) Family who is supporting patient with severe diseases except for congenital heart diseases
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Chishaki |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Health Sciences
Zip code
8128582
Address
3-1-1,Maidashi,Higashi-ku, Fukuoka
TEL
092-642-6713
chishaki@hs.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Chishaki |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Health Sciences
Zip code
8128582
Address
3-1-1,Maidashi,Higashi-ku, Fukuoka
TEL
092-642-6713
Homepage URL
chishaki@hs.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences
Department of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Community Health care Organization Kyushu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address
3-1-1,Maidashi,Higashi-ku, Fukuoka
Tel
092-642-5774
tr-info@med.kyushu-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
九州大学病院（福岡県）/Kyushu University Hospital（Fukuoka）
独立行政法人地域医療機能推進機構九州病院（福岡県）/Japan Community Health care Organization Kyushu Hospital（Fukuoka）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 27 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Questionnaire survey
Management information
Registered date
| 2016 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
