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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||||
Condition | Eating disorders | |||||
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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
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Key exclusion criteria | None | |||
Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
m-suzuki@atomi.ac.jp |
Public contact | |||||||
Name of contact person |
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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= | ||||||
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |