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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019900
Receipt No. 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

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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 Obsterics 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
Email 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
Email k-kawata@hs.med.kyushu-u.ac.jp

Sponsor
Institute Department of Health Sciences, Faculty of Medical Sciences, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022984

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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