UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019900 |
|---|---|
| Receipt number | R000022984 |
| Scientific Title | Construction of the medical information system that provides education and total life care for patients with congenital heart disease. -Establishment of perinatal care system for women with adult congenital heart disease(ACHD)- |
| Date of disclosure of the study information | 2015/11/23 |
| Last modified on | 2015/12/02 14:19:43 |
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Basic information
Public title
Construction of the medical information system that provides education and total life care for patients with congenital heart disease.
-Establishment of perinatal care system for women with adult congenital heart disease(ACHD)-
Acronym
Establishment of perinatal care system for women with adult congenital heart disease(ACHD)
Scientific Title
Construction of the medical information system that provides education and total life care for patients with congenital heart disease.
-Establishment of perinatal care system for women with adult congenital heart disease(ACHD)-
Scientific Title:Acronym
Establishment of perinatal care system for women with adult congenital heart disease(ACHD)
Region
| Japan |
Condition
Condition
Female adult congenital heart disease.
Classification by specialty
| Cardiology | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal information to be necessary regarding perinatal care for women with adult congenital heart disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-administered questionnaire survey.
Mail distribution and return.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Woman from 20 to 49 years old who received a diagnosis of congenital heart disease regardless of the treatment situation.
Woman with adult congenital heart disease who completely understands this study, and has an ability to decide whether or not to participate in it.
Key exclusion criteria
Woman with adult congenital heart disease who has other serious diseases.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Chisyaki |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Health Sciences
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6713
chisyaki@hs.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Kawata |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Health Sciences
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6742
Homepage URL
k-kawata@hs.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Faculty of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Researchers mailed self-administered questionnaires to the target population.
Study subjects:
All female patients from 20 to 49 years old who received a diagnosis of congenital heart disease and had an examination in Kyushu University Hospital from January 1, 2009 until March 31, 2015 and were included to the criteria for this study.
Management information
Registered date
| 2015 | Year | 11 | Month | 23 | Day |
Last modified on
| 2015 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022984
| 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 |
