UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050047 |
|---|---|
| Receipt number | R000057013 |
| Scientific Title | Preconception Education Program Based on the ARCS Motivation Model to Reduce Women's Decisional Conflict About Non-invasive Prenatal Testing: A Quasi-experimental Study among Female Undergraduate Students in Japan |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2023/01/16 14:23:29 |
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Basic information
Public title
Preconception Education Program Based on the ARCS Motivation Model to Reduce Women's Decisional Conflict About Non-invasive Prenatal Testing
Acronym
Preconception Education Program about NIPT based on the ARCS model
Scientific Title
Preconception Education Program Based on the ARCS Motivation Model to Reduce Women's Decisional Conflict About Non-invasive Prenatal Testing: A Quasi-experimental Study among Female Undergraduate Students in Japan
Scientific Title:Acronym
Preconception Education Program about NIPT based on the ARCS model
Region
| Japan |
Condition
Condition
Able-bodied persons: adult women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although non-invasive prenatal testing (NIPT) is offered as a reproductive choice in many countries, pregnant women often have difficulties understanding adequate information and making decisions regarding NIPT. NIPT can be undergone from 9-10 weeks of gestation, and thus health professionals were recommended to discuss women about NIPT at the initial prenatal visit. However, pregnant women were reported to have difficulties understanding adequate information regarding NIPT, and have decisional conflict. Therefore, we developed a preconception education program about NIPT based on the ARCS motivation model which is an instructional design to enhance learning motivation, for women to support decision-making regarding NIPT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decisional conflict scale Japanese version (Arimori, 2006) developed by O'Connor (1995)
The time to assess: before intervention, immediate after intervention, and three months after intervention
Key secondary outcomes
-Knowledge about genetics and prenatal testing (Total 20 items)
-Interest in genetics
-Indecisive attitudes toward NIPT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
This intervention is an education program consisting of five components (two games, a lecture, a discussion, and guidance of continuous learning) based on the Attention, Relevance, Confidence, and Satisfaction (ARCS) motivation model (Keller, 2010). ARCS model is an instructional design that stimulates learning interest and motivation. This education program is for 90 minutes and targeted at women prior to pregnancy.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Women who have never been pregnant
Key exclusion criteria
Women who are unable to understand Japanese
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Katada |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima, Chio-ku, Kobe, Hyogo, Japan
TEL
078-304-3124
c-katada@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Katada |
Organization
Hyogo Medical University
Division name
School of Nursing
Zip code
650-8530
Address
1-3-6 Minatojima, Chio-ku, Kobe, Hyogo, Japan
TEL
078-304-3124
Homepage URL
c-katada@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Chihiro Katada
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
- Department of Nursing, Otemae University, Osaka, Japan
- Department of Nursing, Morinomiya University of Medical Sciences, Osaka, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo University of Health Sciences (currently known as Hyogo Medical University) Ethical Review Committee
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
兵庫医科大学 神戸キャンパス（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K20809/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-16K20809/
Number of participants that the trial has enrolled
73
Results
Interest in genetics, knowledge of genetics and prenatal testing, and indecisive attitudes on NIPT significantly improved immediately after, and consequently, these changes and reduction of decisional conflict were maintained at three months (p<0.001).
Results date posted
| 2023 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 19 | Day |
Baseline Characteristics
Female undergraduate students from two universities in Kobe, Japan
Participant flow
Participants were recruited after classes in which researchers were not involved, and spontaneously enrolled in this study. All participants provided written informed consent.
Adverse events
None
Outcome measures
- Decisional conflict scale Japanese version (Arimori, 2006) developed by O'Connor (1995)
- Knowledge about genetics and prenatal testing (Total 20 items)
- Interest in genetics
- Indecisive attitudes toward NIPT
Plan to share IPD
Not performed
IPD sharing Plan description
Not performed
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057013
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