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利用者名:
UMIN ID:

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000038044
受付番号 R000041898
科学的試験名 精神科訪問看護師による家族心理教育 クラスター無作為化比較対照試験
一般公開日(本登録希望日) 2019/09/18
最終更新日 2021/03/24

※ 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 精神科訪問看護師による家族心理教育 クラスター無作為化比較対照試験 Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses
一般向け試験名略称/Acronym BFPE-PVN BFPE-PVN
科学的試験名/Scientific Title 精神科訪問看護師による家族心理教育 クラスター無作為化比較対照試験 Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses
科学的試験名略称/Scientific Title:Acronym BFPE-PVN BFPE-PVN
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 統合失調症 Schizophrenia
疾患区分1/Classification by specialty
精神神経科学/Psychiatry
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 精神科訪問看護師が統合失調症をもつ本人をケアする家族に対して、簡易的な家族心理教育を行うことで家族の負担感が軽減するかをクラスター無作為化比較対照試験により明らかにする。 The purpose of this study is to clarify, through a cluster randomized controlled trial, whether to have visiting nurses providing BFP to families caring for people with schizophrenia will alleviate the family burden.
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 Zarit burden interview (ZBI-22)

ベースライン、介入1か月後、介入6か月後に評価する。
Zarit burden interview (ZBI-22)

The outcome assessments will be conducted at baseline, 1-month follow-up and 6-month follow-up.
副次アウトカム評価項目/Key secondary outcomes 家族のアウトカム
K6
General Self Efficacy Scale (GSES)
WHO-5
Knowledge of Illness and Drug inventory (KIDI)

当事者のアウトカム
Behavior and Symptoms Identification Scale (BASIS-32)
WHO-5
Hospitalization at 6-month follow-up

ベースライン、介入1か月後、介入6か月後に評価する。

6か月後の再入院の有無に関しては、介護者が、ベースラインと介入6か月後に評価する。
Family outcome
K6
General Self Efficacy Scale (GSES)
WHO-5
Knowledge of Illness and Drug inventory (KIDI)

People with schizophrenia outcome
Behavior and Symptoms Identification Scale (BASIS-32)
WHO-5
Hospitalization at 6-month follow-up

The outcome assessments will be conducted at baseline, 1-month follow-up and 6-month follow-up.

Hospitalization at 6-month follow-up is provided by the caregiver at the baseline and the six-month follow-up.

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 集団/Cluster
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification はい/YES
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設をブロックとみなしている/Institution is considered as a block.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 中央登録/Central registration

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1 介入群は、精神科訪問看護師が家族に対して、簡易的な家族心理教育を行う。1回60分程度、全4回からなり、1か月で介入を終了する。 This brief FPE program is single family intervention conducted by psychiatric visiting nurses, which is comprised of 4 modules that last 60 min in length and will be completed over the period of a month.
介入2/Interventions/Control_2 コントロールは通常の支援を受ける Treatment as usual
介入3/Interventions/Control_3

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

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 精神科訪問看護を専門に行っている精神科訪問看護ステーションであること。各施設は、少なくとも統合失調症を2例以上担当していること。

・支援をうけるご本人のご家族(主介護者)
①統合失調症ををもつご本人をケアしている主介護者である。

②ご家族は同意取得時において年齢が20歳以上の者

③ご家族は両親、兄弟、姉妹、配偶者、子など家族関係にあるもの

④ご家族はご本人と同居していること

・支援を受けるご本人
①ICD-10により、統合失調症であると診断されている。

②精神科訪問看護師による支援を受けている者
Inclusion criteria for a visiting nurse agency is that the visiting nurse mainly provided their services for psychiatric patients/clients rather than elderly people or those with other physical diseases at least one year or more. In each agency, visiting nurses care for people with schizophrenia who live with their family at least two cases. There are no exclusion criteria at the cluster level.

In terms of the participation criteria at the individual level, we set the following inclusion criteria for a caregiver of people with schizophrenia: 1) a primary caregiver who takes care of people with schizophrenia, 2) a caregiver is over 20 years old, 3) a caregiver has a family relationship with people with schizophrenia such as parents, brothers, sisters, spouses and children and 4) a caregiver is living with people with schizophrenia. There are no exclusion criteria for a caregiver of people with schizophrenia.

In addition, the inclusion criteria for people with schizophrenia is as follows: 1) People diagnosed with schizophrenia by using ICD-10, 2) people with schizophrenia use the service of visiting nurses.
除外基準/Key exclusion criteria なし None
目標参加者数/Target sample size 220

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
憲人
ミドルネーム
川上
Norito
ミドルネーム
Kawakami
所属組織/Organization 東京大学大学院医学研究科 Graduate School of Medicine, The University of Tokyo
所属部署/Division name 精神保健学教室 Department of Mental Health
郵便番号/Zip code 1130033
住所/Address 東京都文京区本郷7-3-1 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
電話/TEL +81-3-5841-3521
Email/Email norito@m.u-tokyo.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
尚徳
ミドルネーム
安間
Naonori
ミドルネーム
Yasuma
組織名/Organization 東京大学大学院医学研究科 Graduate School of Medicine, The University of Tokyo
部署名/Division name 精神保健学教室 Department of Mental Health
郵便番号/Zip code 1130033
住所/Address 東京都文京区本郷7-3-1 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
電話/TEL +81-3-5841-3521
試験のホームページURL/Homepage URL
Email/Email nnyy712@gmail.com

実施責任組織/Sponsor
機関名/Institute 東京大学 Graduate School of Medicine, The University of Tokyo Department of Mental Health
機関名/Institute
(機関選択不可の場合)

部署名/Department 精神保健学教室

研究費提供組織/Funding Source
機関名/Organization 国立研究開発法人国立精神・神経医療研究センター National Center of Neurology and Psychiatry
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他/Other
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 国立精神・神経医療研究センター 精神保健研究所 地域・司法精神医療研究部 Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan
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 東京大学大学院医学系研究科・医学部 倫理委員会 Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
住所/Address 東京都文京区本郷7-3-1 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
電話/Tel +81-3-5841-0818
Email/Email ethics@m.u-tokyo.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 09 18

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 83
主な結果/Results For family caregivers of people with schizophrenia, there was no statistically significant effect of BFP on ZBI-22, K6, GSES, WHO-5 and KIDI at 1-month and 6-month follow-up.

For people with schizophrenia, the effect of BFP on BASIS-32 and WHO-5 were not statistically significant at both 1- and 6-month follow up.

For family caregivers of people with schizophrenia, there was no statistically significant effect of BFP on ZBI-22, K6, GSES, WHO-5 and KIDI at 1-month and 6-month follow-up.

For people with schizophrenia, the effect of BFP on BASIS-32 and WHO-5 were not statistically significant at both 1- and 6-month follow up.


主な結果入力日/Results date posted
2021 03 24
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
参加者背景/Baseline Characteristics Most of the participants of family caregivers of people with schizophrenia were elderly mothers who were not working and half of them had experienced with care for more than 10 years.

Most of the participants of people with schizophrenia were unemployed and never married, had been schizophrenia for more than 10 years and had used visiting nurses for more than three years. The average number of lifetime hospitalization was 3.0 times in the intervention group and 4.7 times in the control group. Three participants (7%) in the intervention group and two participants (5%) in the control group had been experienced with hospitalization within 6 months before the study.
Most of the participants of family caregivers of people with schizophrenia were elderly mothers who were not working and half of them had experienced with care for more than 10 years.

Most of the participants of people with schizophrenia were unemployed and never married, had been schizophrenia for more than 10 years and had used visiting nurses for more than three years. The average number of lifetime hospitalization was 3.0 times in the intervention group and 4.7 times in the control group. Three participants (7%) in the intervention group and two participants (5%) in the control group had been experienced with hospitalization within 6 months before the study.
参加者の流れ/Participant flow Forty-seven visiting nurse agencies (69%) agreed to participate in the study among the recruited agencies. As a result of randomization, twenty-five visiting nurse agencies were allocated to intervention group and twenty-two visiting nurse agencies to the control group. Thirteen visiting nurse agencies could not recruit any participants. From the thirty-four visiting nurse agencies, 83 family caregivers of people with schizophrenia and 83 people with schizophrenia completed the baseline survey. At the 6-month follow-up survey, seventeen agencies (100%), 43 family caregivers of people with schizophrenia (100%) and 40 people with schizophrenia (93%) in the intervention group and fifteen agencies (88%), 36 family caregivers of people with schizophrenia (90%) and 33 people with schizophrenia (83%) in the control group completed the follow up survey. The reason for dropping out was hospitalization (n2=6), due to COVID-19 pandemic (N=2, n1=4, n2=4). [N=the number of visiting nurse agencies, n1=the number of family caregivers of people with schizophrenia, n2=the number of people with schizophrenia] Forty-seven visiting nurse agencies (69%) agreed to participate in the study among the recruited agencies. As a result of randomization, twenty-five visiting nurse agencies were allocated to intervention group and twenty-two visiting nurse agencies to the control group. Thirteen visiting nurse agencies could not recruit any participants. From the thirty-four visiting nurse agencies, 83 family caregivers of people with schizophrenia and 83 people with schizophrenia completed the baseline survey. At the 6-month follow-up survey, seventeen agencies (100%), 43 family caregivers of people with schizophrenia (100%) and 40 people with schizophrenia (93%) in the intervention group and fifteen agencies (88%), 36 family caregivers of people with schizophrenia (90%) and 33 people with schizophrenia (83%) in the control group completed the follow up survey. The reason for dropping out was hospitalization (n2=6), due to COVID-19 pandemic (N=2, n1=4, n2=4). [N=the number of visiting nurse agencies, n1=the number of family caregivers of people with schizophrenia, n2=the number of people with schizophrenia]
有害事象/Adverse events none none
評価項目/Outcome measures ZBI-22, K6, GSES, WHO-5, KIDI
BASIS-32, WHO-5


ZBI-22, K6, GSES, WHO-5, KIDI
BASIS-32, WHO-5
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 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2019 09 18
倫理委員会による承認日/Date of IRB
2019 09 18
登録・組入れ開始(予定)日/Anticipated trial start date
2019 09 18
フォロー終了(予定)日/Last follow-up date
2020 05 31
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
Data Sharing Statements that fulfill ICMJE Requirements

Will individual participant data be available (including data dictionaries)?
answer:Yes

What data in particular will be shared?
answer:All of the individual participant data collected during the trial, after deidentification.

What other documents will be available?
answer:Study Protocol, Statistical Analysis Plan, Analytic Code

When will data be available (start and end dates)?
answer:Immediately following publication. No end date.

With whom?
answer:Anyone who wishes to access the data.

For what types of analyses?
answer:Any purpose.

By what mechanism will data be made available?
answer:Data are available indefinitely.

管理情報/Management information
登録日時/Registered date
2019 09 18
最終更新日/Last modified on
2021 03 24


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=R000041898
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041898

研究計画書
登録日時 ファイル名

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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