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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036587
Receipt No. R000041678
Scientific Title Support Intervention for Leader of Chemical Sensitivity Patient Group and Follow-up Survey of Psychosocial Health Status
Date of disclosure of the study information 2019/04/24
Last modified on 2019/04/24

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Basic information
Public title Support Intervention for Leader of Chemical Sensitivity Patient Group and Follow-up Survey of Psychosocial Health Status
Acronym CS support research
Scientific Title Support Intervention for Leader of Chemical Sensitivity Patient Group and Follow-up Survey of Psychosocial Health Status
Scientific Title:Acronym Support intervention and Survey for MCS
Region
Japan

Condition
Condition multiple chemical sensitivity syndrome
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to establish a communication base for representatives (GL) of MCS patients self-help group, and to trace changes in their psychosocial health status by repeating nursing intervention on the spot.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sense of burden on support activities of GL
GL mental health condition
State of activities and organizational management of GL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Follow the changes in GL's psychosocial health status for 2 years, repeating the consultation and advice by nurses
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. Patients who are diagnosed with MCS and belong to Japanese patient self-help group, and who is the head of these groups.
2. Adult (over 20 years old), gender does not matter.
3. After sufficient explanation about participation in this study, written consent was obtained by the patient's own free will.
Key exclusion criteria nothing
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Nami
Middle name
Last name IMAI
Organization Mie University
Division name Graduate School of Medicine
Zip code 5148507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-231-5093
Email nami-i@nurse.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Nami
Middle name
Last name IMAI
Organization Mie university
Division name Graduate School of Medicine
Zip code 5148507
Address 2-174 Edobashi
TEL 059-231-5093
Homepage URL
Email nami-i@nurse.medic.mie-u.ac.jp

Sponsor
Institute Mie 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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization MIe University
Address 2-174 Edobashi
Tel +81-59-231-5093
Email nami-i@nurse.medic.mie-u.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 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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