Unique ID issued by UMIN | UMIN000038044 |
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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 |
Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses
BFPE-PVN
Effects of brief family psychoeducation for caregivers of people with schizophrenia in Japan provided by visiting nurses
BFPE-PVN
Japan |
Schizophrenia
Psychiatry |
Others
NO
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.
Efficacy
Zarit burden interview (ZBI-22)
The outcome assessments will be conducted at baseline, 1-month follow-up and 6-month follow-up.
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.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
No treatment
YES
NO
Institution is considered as a block.
NO
Central registration
2
Educational,Counseling,Training
Behavior,custom |
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.
Treatment as usual
20 | years-old | <= |
Not applicable |
Male and Female
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.
None
220
1st name | Norito |
Middle name | |
Last name | Kawakami |
Graduate School of Medicine, The University of Tokyo
Department of Mental Health
1130033
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
+81-3-5841-3521
norito@m.u-tokyo.ac.jp
1st name | Naonori |
Middle name | |
Last name | Yasuma |
Graduate School of Medicine, The University of Tokyo
Department of Mental Health
1130033
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
+81-3-5841-3521
nnyy712@gmail.com
Graduate School of Medicine, The University of Tokyo Department of Mental Health
National Center of Neurology and Psychiatry
Other
Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2019 | Year | 09 | Month | 18 | Day |
n/a
Unpublished
n/a
83
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.
2021 | Year | 03 | Month | 24 | Day |
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.
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]
none
ZBI-22, K6, GSES, WHO-5, KIDI
BASIS-32, WHO-5
Completed
2019 | Year | 09 | Month | 18 | Day |
2019 | Year | 09 | Month | 18 | Day |
2019 | Year | 09 | Month | 18 | Day |
2020 | Year | 05 | Month | 31 | Day |
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.
2019 | Year | 09 | Month | 18 | Day |
2022 | Year | 03 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041898
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