UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059478 |
|---|---|
| Receipt number | R000067826 |
| Scientific Title | Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide |
| Date of disclosure of the study information | 2025/10/20 |
| Last modified on | 2025/10/20 21:46:58 |
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Basic information
Public title
Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide
Acronym
A Study on Counseling to Support Couples Who Are Considering Prenatal Testing
Scientific Title
Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide
Scientific Title:Acronym
COUPLE-DECIDE RCT
Region
| Japan |
Condition
Condition
Couples without children
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine support for couples' decision-making regarding prenatal testing. Participants will be randomly assigned, with the intervention group receiving support using the Ottawa Decision Support Guide, and the control group receiving decision-making support without the use of the tool. The study aims to clarify differences between the two groups in decisional conflict, couples' communication attitudes, and the impact of reaching joint decisions on subsequent relationship quality. Findings are expected to inform genetic counseling, genetics education, and preconception care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Couples' communication attitudes will be assessed using the Japanese version of the CPQ, with particular focus on the scores for "mutually constructive" and "constructive communication." These scores will be compared between the intervention and control groups. Participants will complete the Japanese CPQ at study enrollment, immediately after the intervention, and one month after the intervention.
Key secondary outcomes
Study participants will complete the Decisional Conflict Scale (DCS) immediately after the intervention. Scores on the DCS will be compared between the intervention and control groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will receive support for couples' decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide.
Interventions/Control_2
The intervention group will receive support for couples' decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 18 years or older
Couples without children
Wife under 50 years of age
Couples married for 10 years or less
Key exclusion criteria
Couples who have children
Individuals who have experienced fertility treatment
Those who have previously received genetic counseling related to NIPT
Individuals who are unable to participate in the study online (e.g., cannot access Zoom or complete web-based questionnaires)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mikako |
| Middle name | |
| Last name | Miyata |
Organization
Doctoral Program, Department of Nursing Science, Graduate School of Biomedical Sciences, Nagasaki University
Division name
Doctoral Program, Department of Nursing Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7907
bb55319028@ms.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Miyata |
Organization
Department of Nursing Science, Graduate School of Biomedical Sciences, Nagasaki University
Division name
Doctoral Program, Department of Nursing Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
095-819-7907
Homepage URL
bb55319028@ms.nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki 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
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
Tel
095-819-7907
bb55319028@ms.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067826
