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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048425
Receipt No. R000055189
Scientific Title A randomized controlled trial to study effectiveness of peer support on family taking care of eating disorder patients
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/21

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Basic information
Public title A study of peer support for family taking care of eating disorder patients
Acronym ED family peer study
Scientific Title A randomized controlled trial to study effectiveness of peer support on family taking care of eating disorder patients
Scientific Title:Acronym ED family peer support RCT study
Region
Japan

Condition
Condition Eating disorders
Classification by specialty
Medicine in general Endocrinology and Metabolism Psychosomatic Internal Medicine
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study of effectiveness of consultation of peer supporters (trained by our program) on mood and burden feeling of family taking care of eating disorder patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mood change estimated by the Japanese edition of Profile of Mood States 2nd Edition (POMS2)
Key secondary outcomes Care burden feeling estimated by the short version of Japanese version of the Zarit caregiver burden questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: Subjects who take inventory survey just before and within two weeks after consultation by peer supporters
Interventions/Control_2 Control group: Subjects who take inventory survey on entry of the waiting list and just before consultation by peer supporters
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A person who is over 18 years old, a father or a mother who has experience of taking care of eating disorder patients and signed written consent of this study

Key exclusion criteria None
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mari
Middle name
Last name Suzuki
Organization Atomi University
Division name Faculty of Psychology, Department of Clinical Psychology
Zip code 352-8501
Address 1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
TEL 048-478-3333
Email m-suzuki@atomi.ac.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Suzuki
Organization Atomi University
Division name Faculty of Psychology, Department of Clinical Psychology
Zip code 352-8501
Address 1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
TEL 048-478-3333
Homepage URL https://select-type.com/ev/?ev=sQa8kYYnkUA&eventPageID=
Email m-suzuki@atomi.ac.jp

Sponsor
Institute Atomi University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Jao

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

IRB Contact (For public release)
Organization Atomi University
Address 1-9-6 Nakano, Niiza-shi, Saitama 352-8501 Japan
Tel 048-478-3333
Email d-shomu@atomi.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 跡見学園女子大学(埼玉県)

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 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
2022 Year 06 Month 07 Day
Date of IRB
2022 Year 06 Month 01 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2022 Year 10 Month 31 Day
Date of closure to data entry
2023 Year 05 Month 31 Day
Date trial data considered complete
2023 Year 06 Month 30 Day
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2022 Year 07 Month 21 Day
Last modified on
2022 Year 07 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055189

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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