UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038044
Receipt number R000041898
Scientific Title Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses
Date of disclosure of the study information 2019/09/18
Last modified on 2022/03/23 08:18:41

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Basic information

Public title

Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses

Acronym

BFPE-PVN

Scientific Title

Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses

Scientific Title:Acronym

BFPE-PVN

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Zarit burden interview (ZBI-22)

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

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

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.

Interventions/Control_2

Treatment as usual

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


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

None

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Norito
Middle name
Last name Kawakami

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5841-3521

Email

norito@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Naonori
Middle name
Last name Yasuma

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5841-3521

Homepage URL


Email

nnyy712@gmail.com


Sponsor or person

Institute

Graduate School of Medicine, The University of Tokyo Department of Mental Health

Institute

Department

Personal name



Funding Source

Organization

National Center of Neurology and Psychiatry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan

Name of secondary funder(s)



IRB Contact (For public release)

Organization

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

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

+81-3-5841-0818

Email

ethics@m.u-tokyo.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 09 Month 18 Day


Related information

URL releasing protocol

n/a

Publication of results

Unpublished


Result

URL related to results and publications

n/a

Number of participants that the trial has enrolled

83

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.


Results date posted

2021 Year 03 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


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.

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]

Adverse events

none

Outcome measures

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

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 18 Day

Date of IRB

2019 Year 09 Month 18 Day

Anticipated trial start date

2019 Year 09 Month 18 Day

Last follow-up date

2020 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

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.


Management information

Registered date

2019 Year 09 Month 18 Day

Last modified on

2022 Year 03 Month 23 Day



Link to view the page

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name