UMIN-CTR Clinical Trial

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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