UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021701 |
|---|---|
| Receipt number | R000025035 |
| Scientific Title | Effects and social meanings of peer-support: a monitoring study in community service agencies and a cohort study for peer-support |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2020/04/03 10:29:25 |
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Basic information
Public title
Effects and social meanings of peer-support: a monitoring study in community service agencies and a cohort study for peer-support
Acronym
Peer-support and longitudinal study in Japan (PAL-J)
Scientific Title
Effects and social meanings of peer-support: a monitoring study in community service agencies and a cohort study for peer-support
Scientific Title:Acronym
Peer-support and longitudinal study in Japan (PAL-J)
Region
| Japan |
Condition
Condition
Mental illness
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of peer-support.
Basic objectives2
Others
Basic objectives -Others
To assess the effectiveness of peer-support on users' outcomes at 18-month follow-up, comparing community service agencies with peer-staff members and other community service agencies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
service satisfaction
Key secondary outcomes
Quality of life, subjective recovery, social support/network, self-stigma, motivation, function and symptoms
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. New user registered in each agency
2. Over 20 years-old
Key exclusion criteria
Dementia, substance abuse, intellectual disability, and developmental disability
Target sample size
259
Research contact person
Name of lead principal investigator
| 1st name | Aikawa |
| Middle name | |
| Last name | Ayako |
Organization
Seigakuin University
Division name
Faculty of Human Welfare, Human Welfare Deptartment
Zip code
362-8585
Address
1-1, Tosaki, Ageo, Saitama, Postal code:362-8585
TEL
048-780-1863
a_aikawa@seigakuin-univ.ac.jp
Public contact
Name of contact person
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Sosei |
Organization
National Center of Neurology and Psychiatry (NCNP)
Division name
Department of Psychiatric Rehabilitation, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo Postal code:187-8553
TEL
042-346-2168
Homepage URL
http://pal-j.jp/
sosei.yama@ncnp.go.jp
Sponsor or person
Institute
Seigakuin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Seigakuin University
Address
1-1 Todaki, Ageo, Saitama, 362-8585
Tel
048-725-5524
research@seigakuin-univ.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
| 2016 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000025035
Publication of results
Published
Result
URL related to results and publications
https://arcmedium.co.jp/products/detail.php?product_id=2796
Number of participants that the trial has enrolled
72
Results
Number of baseline assessments, n = 72
Number of 18-month follow-up assessment, n = 47
(Exposure group n =33 and non-exposure group n = 14)
The exposure group indicates that people with mental illness utilized community service agencies where employ peer-support workers. The non- exposure group means that participants did not use such an agency.
All the outcomes including the primary outcome (service satisfaction) were not significantly different between the group.
Results date posted
| 2020 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Males were 60% in the exposure group and 50% in the non-exposure group. In both groups, the mean age was approximately 45 years-old. The most frequent diagnosis was schizophrenia in each group. There was no significant difference in most demographics and all the outcome scores between the groups at baseline. The proportions of the exposure group's participants who lived in Kanto-area and used a community activity support center were significantly larger, compared to those the non-exposure group.
Participant flow
72 people with mental illness voluntarily participated in this research, and 47 participants completed their 18-months follow-up assessment (Exposure group n =33 and non-exposure group n = 14).
Adverse events
None
Outcome measures
The present study assessed participant's service satisfaction as the primary outcome and other outcomes using multiple patient-reported outcome scales. However, there were no significant differences in all the outcome scale scores between the groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Study design: Prospective longitudinal/cohort study (The exposure: "being peer-staff")
Agencies: community activity support centers or employment service agencies for continuous employment (type B) in capital region and Fukuoka prefecture (a total of 31 agencies) participated in this study.
Participants: 1) the new users registered in the above agencies between 1st April 2016 and 31st March 2017, who 2) have mental illness with 3) over 20 year old and 4)consent to participate in this study.
Exclusion criteria: main diagnosis is dementia, substance abuse, intellectual disability and developmental disability.
Recruitment period: 1st April 2016 to 31st May 2017. But, we may close the recruitment when the number of participants reaches the necessary sample size.
Explanation about this study and informed consent were provided by the staff who received a training in each agency.
Follow-up period: 18 months
The timing of outcome assessment: baseline assessment, 9-month follow-up assessment, and 18-month follow-up assessment after participant enrollment.
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025035
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
