UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054793 |
|---|---|
| Receipt number | R000062404 |
| Scientific Title | Intervention study through family education program, assessed with the questionnaire of burden on support for caregivers with chronic diseases |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/27 09:50:36 |
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Basic information
Public title
Intervention study through family education program, assessed with the questionnaire of burden on support for caregivers with chronic diseases
Acronym
Intervention study through family education program, assessed with the questionnaire of burden on support for caregivers with chronic diseases
Scientific Title
Intervention study through family education program, assessed with the questionnaire of burden on support for caregivers with chronic diseases
Scientific Title:Acronym
Intervention study through family education program, assessed with the questionnaire of burden on support for caregivers with chronic diseases
Region
| Japan |
Condition
Condition
autism spectrum disorder, eating disorder, schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A total of six family education programs will be conducted for caregivers with chronic illnesses including autism spectrum disorder, eating disorder, and schizophrenia, to compare the burden of caregiving before and after participation and to introduce medical care based on Measurement Based Care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Zarit Caregiver Burden Scale Japanese version
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
| Other |
Interventions/Control_1
A total of six family education programs will be conducted using programs designed by our department, for 30 caregivers with autism spectrum disorder, 30 caregivers with eating disorders, and 30 caregivers with schizophrenia.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Family members (third-degree relatives or other primary caregivers) of patients who meet the diagnostic criteria for autism spectrum disorder, eating disorder, or schizophrenia based on ICD-11 and DSM-5-TR diagnostic criteria.
2.Individuals who understand this study and give their consent to participate in this study with the signature on the consent form.
Key exclusion criteria
1. Those who have requested not to participate in this study.
2. Those who failed to attend a total of 6 family classes.
3. Individuals considered inappropriate by the project member of this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Mouri |
Organization
Kobe University Hospital
Division name
Department of Psychiatry
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL
078-382-6065
kmoris@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Mouri |
Organization
Kobe University Hospital
Division name
Department of Psychiatry
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL
078-382-6065
Homepage URL
kmoris@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture
Tel
078-382-6065
kainyu@med.kobe-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
| 2024 | 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
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062404
