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試験進捗状況 主たる結果の公表済み/Main results already published
UMIN試験ID UMIN000035736
受付番号 R000040108
科学的試験名 チャットボットを用いたプレコンセプションケアの啓発と評価
一般公開日(本登録希望日) 2019/02/01
最終更新日 2020/09/28

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title チャットボットを用いたプレコンセプションケアの啓発と評価 Effects of chatbot for preconception care: a randomized controlled study
一般向け試験名略称/Acronym プレコンセプションケアにおけるチャットボットの有効性 Chatbot for preconception care
科学的試験名/Scientific Title チャットボットを用いたプレコンセプションケアの啓発と評価 Effects of chatbot for preconception care: a randomized controlled study
科学的試験名略称/Scientific Title:Acronym プレコンセプションケアにおけるチャットボットの有効性 Chatbot for preconception care
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 妊孕性 fertility
疾患区分1/Classification by specialty
該当せず/Not applicable 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 プレコンセプション教育におけるチャットボットの教育効果測定 Measurement of the effects of chatbot for preconception education on knowledge and lifestyle changes
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes 曝露後の妊孕性知識(Cardiff Fertility Knowledge scale) The score of the Cardiff Fertility Knowledge scale after exposure
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification はい/YES
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 3
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1 チャットボット chatbot
介入2/Interventions/Control_2 妊孕性に関する文書 written material for fertility
介入3/Interventions/Control_3 無関係の文書 written material regarding health insurance
介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
34 歳/years-old 以下/>=
性別/Gender 女/Female
選択基準/Key inclusion criteria いつか子どもを希望する健康な女性 women who hope to have a child in the future
除外基準/Key exclusion criteria 医療関係者・広告業関係者
妊娠中
medical professionals or advertisement professionals; not currently pregnant
目標参加者数/Target sample size 930

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
恵理
ミドルネーム
前田
Eri
ミドルネーム
Maeda
所属組織/Organization 秋田大学 Akita University
所属部署/Division name 衛生学・公衆衛生学 Environmental Health Science and Public Health
郵便番号/Zip code 010-8543
住所/Address 秋田市本道1-1-1 Hondo1-1-1, Akita, Japan
電話/TEL 018-884-6087
Email/Email erimaeda@med.akita-u.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
恵理
ミドルネーム
前田
Eri
ミドルネーム
Maeda
組織名/Organization 秋田大学 Akita University
部署名/Division name 衛生学公衆衛生学 Environmental Health Science and Public Health
郵便番号/Zip code 010-0001
住所/Address 秋田市本道1-1-1 Hondo1-1-1, Akita, Japan
電話/TEL 018-884-6083
試験のホームページURL/Homepage URL
Email/Email erimaeda@med.akita-u.ac.jp

実施責任組織/Sponsor
機関名/Institute 秋田大学 Akita Univeristy
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Pfizer Health Research Foundation
機関名/Organization
(機関選択不可の場合)
ファイザーヘルスリサーチ振興財団
組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization 秋田大学 Akita University
住所/Address 秋田市本道1-1-1 Hondo1-1-1, Akita
電話/Tel 018-884-6461
Email/Email soken@hos.akita-u.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 02 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://www.rbmojournal.com/article/S1472-6483(20)30510-1/abstract
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://www.rbmojournal.com/article/S1472-6483(20)30510-1/abstract
組み入れ参加者数/Number of participants that the trial has enrolled 927
主な結果/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. 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.
主な結果入力日/Results date posted
2020 09 28
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
2020 09 10
参加者背景/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. 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.
参加者の流れ/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. 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.
有害事象/Adverse events No adverse events. No adverse events.
評価項目/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.
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.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 主たる結果の公表済み/Main results already published
プロトコル確定日/Date of protocol fixation
2019 03 10
倫理委員会による承認日/Date of IRB
2018 03 29
登録・組入れ開始(予定)日/Anticipated trial start date
2019 03 13
フォロー終了(予定)日/Last follow-up date
2019 03 22
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2019 02 01
最終更新日/Last modified on
2020 09 28


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040108
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040108

研究計画書
登録日時 ファイル名
2020/05/22 研究計画書(チャットボット)20190308.pdf

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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