UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035736 |
|---|---|
| Receipt number | R000040108 |
| Scientific Title | Effects of chatbot for preconception care: a randomized controlled study |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2020/09/28 12:13:02 |
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Basic information
Public title
Effects of chatbot for preconception care: a randomized controlled study
Acronym
Chatbot for preconception care
Scientific Title
Effects of chatbot for preconception care: a randomized controlled study
Scientific Title:Acronym
Chatbot for preconception care
Region
| Japan |
Condition
Condition
fertility
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of the effects of chatbot for preconception education on knowledge and lifestyle changes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of the Cardiff Fertility Knowledge scale after exposure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
chatbot
Interventions/Control_2
written material for fertility
Interventions/Control_3
written material regarding health insurance
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
| 34 | years-old | >= |
Gender
Female
Key inclusion criteria
women who hope to have a child in the future
Key exclusion criteria
medical professionals or advertisement professionals; not currently pregnant
Target sample size
930
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University
Division name
Environmental Health Science and Public Health
Zip code
010-8543
Address
Hondo1-1-1, Akita, Japan
TEL
018-884-6087
erimaeda@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University
Division name
Environmental Health Science and Public Health
Zip code
010-0001
Address
Hondo1-1-1, Akita, Japan
TEL
018-884-6083
Homepage URL
erimaeda@med.akita-u.ac.jp
Sponsor or person
Institute
Akita Univeristy
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University
Address
Hondo1-1-1, Akita
Tel
018-884-6461
soken@hos.akita-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
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.rbmojournal.com/article/S1472-6483(20)30510-1/abstract
Publication of results
Published
Result
URL related to results and publications
https://www.rbmojournal.com/article/S1472-6483(20)30510-1/abstract
Number of participants that the trial has enrolled
927
Results
Providing fertility education using a chatbot improved fertility knowledge and intentions to optimise preconception behaviour without increasing anxiety, but the improvement in knowledge was small. Further technical development and exploration of personal affinity for technology is required.
Results date posted
| 2020 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 10 | Day |
Baseline Characteristics
Participants were about 29 years old, and more than 60% had a university education, which was higher than the national university enrolment ratio of 43% among female high school graduates in 2008. Less than half were married, and most had no children. Baseline sociodemographic status was well-balanced between groups.
Participant flow
An online market research company, which has a nationwide social research panel of more than 1 million registrants, sent a pre-screening questionnaire regarding the inclusion criteria to 196195 randomly selected female registrants aged 20-34 years. Of the 10000 women who responded to the screening questions, 2524 were eligible. Among the 1,813 who were randomly selected from the eligible respondents and received recruitment emails, 927 completed the survey. Participants were then randomized to one of the three previously described groups using a computerized central allocation system. Participants did not learn of their group assignment until they completed the post-test survey.
Adverse events
No adverse events.
Outcome measures
The percentages of correct scores on the pre-test CFKS-J were similar between groups. A repeated-measures ANOVA of the scores on the CFKS-J showed a significant interaction between group and time. Simple effects of time for each group showed that knowledge improved over time in the IG and CG1. The post-test CFKS-J score for the IG was 7.7 points lower than that of CG1 and 6.7 points higher than that of CG2.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040108
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/22 | 研究計画書（チャットボット）20190308.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
