UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021701
Receipt No. 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 (Ver. 11)

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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
Email 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/
Email sosei.yama@ncnp.go.jp

Sponsor
Institute Seigakuin University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025035