UMIN-CTR Clinical Trial

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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041898