UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
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

英語
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

日本語
BFPE-PVN

英語
BFPE-PVN

科学的試験名/Scientific Title

日本語
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

英語
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

日本語
BFPE-PVN

英語
BFPE-PVN

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
統合失調症

英語
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1/Narrative objectives1

日本語
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。

英語
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

日本語

英語

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

主要アウトカム評価項目/Primary outcomes

日本語
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。

英語
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

日本語
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。

英語
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.

試験の種類/Study type

介入/Interventional

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

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

日本語
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。

英語
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

日本語
コントロールは通常の支援を受ける

英語
Treatment as usual

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

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

日本語
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

英語
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

日本語
なし

英語
None

目標参加者数/Target sample size

220

責任研究者/Name of lead principal investigator

日本語

名	憲人
ミドルネーム
姓	川上

英語

名	Norito
ミドルネーム
姓	Kawakami

所属組織/Organization

日本語
東京大学大学院医学研究科

英語
Graduate School of Medicine, The University of Tokyo

所属部署/Division name

日本語
精神保健学教室

英語
Department of Mental Health

郵便番号/Zip code

1130033

住所/Address

日本語
東京都文京区本郷7-3-1

英語
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担当者/Name of contact person

日本語

名	尚徳
ミドルネーム
姓	安間

英語

名	Naonori
ミドルネーム
姓	Yasuma

組織名/Organization

日本語
東京大学大学院医学研究科

英語
Graduate School of Medicine, The University of Tokyo

部署名/Division name

日本語
精神保健学教室

英語
Department of Mental Health

郵便番号/Zip code

1130033

住所/Address

日本語
東京都文京区本郷7-3-1

英語
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

機関名/Institute

日本語
東京大学

英語
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）

日本語

部署名/Department

日本語
精神保健学教室

個人名/Personal name

日本語

英語

機関名/Organization

日本語
国立研究開発法人国立精神・神経医療研究センター

英語
National Center of Neurology and Psychiatry

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語
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

英語
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)

日本語

英語

組織名/Organization

日本語
東京大学大学院医学系研究科・医学部 倫理委員会

英語
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

住所/Address

日本語
東京都文京区本郷7-3-1

英語
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

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2019

年

09

月

18

日

プロトコル掲載URL/URL releasing protocol

n/a

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

n/a

組み入れ参加者数/Number of participants that the trial has enrolled

83

主な結果/Results

日本語
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.

英語
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

年

03

月

24

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

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

日本語
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.

英語
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

日本語
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]

英語
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

日本語
none

英語
none

評価項目/Outcome measures

日本語
ZBI-22, K6, GSES, WHO-5, KIDI
BASIS-32, WHO-5

英語
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

日本語

英語

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

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2019

年

09

月

18

日

倫理委員会による承認日/Date of IRB

2019

年

09

月

18

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

09

月

18

日

フォロー終了(予定)日/Last follow-up date

2020

年

05

月

31

日

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

その他関連情報/Other related information

日本語

英語
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.

登録日時/Registered date

2019

年

09

月

18

日

最終更新日/Last modified on

2022

年

03

月

23

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041898

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041898