UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031698 |
|---|---|
| Receipt number | R000036152 |
| Scientific Title | Psycho-social predictors of recovery in patients with eating disorder: a cohort study |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2020/09/26 17:52:47 |
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Basic information
Public title
Psycho-social predictors of recovery in patients with eating disorder: a cohort study
Acronym
Recovery of eating disorder with patient and mother
Scientific Title
Psycho-social predictors of recovery in patients with eating disorder: a cohort study
Scientific Title:Acronym
Recovery of eating disorder with patient and mother
Region
| Japan |
Condition
Condition
Eating diorder
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether the recuction of mother's loneliness contribute improving ED symptoms of patients with ED.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to examine whether the recuction of mother's loneliness contribute improving ED symptoms of patients with ED.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reduction of mother's loneliness measured by UCLA loneliness scale contribute improving ED symptoms of patients with ED measured by Eating Disorder Inventory.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
The participant are patients with eating disorder and their mothers. Inclusion criteria are: the patient met the criteria for eating disorder; patients are inpatients, outpatients and in the treatment interruption; the patients are aged between 16 and 50 years; the mothers are aged between 30 and 85 years.
Key exclusion criteria
They con not read or write in Japanese
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujika Katsuki |
Organization
Nagoya City University
Division name
School of Nursing
Zip code
Address
Kawasumi 1, Mizuho-ku, Misuho-cho, Nagoya
TEL
052-853-8048
katsuki@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujika Katsuki |
Organization
Nagoya City University
Division name
School of Nursing
Zip code
Address
Kawasumi 1, Mizuho-ku, Misuho-cho, Nagoya
TEL
052-853-8048
Homepage URL
katsuki@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, 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
Address
Tel
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
| 2018 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment (Patients)
Self esteem
Loneliness
Assertion
Eating disorder symptoms
Family function
Assessment (Mothers)
Social support
Self-efficacy
Loneliness
Active listening
Depression
Mental Health
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036152
