UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049838 |
|---|---|
| Receipt number | R000056683 |
| Scientific Title | Feasibility study of an educational support program for family caregivers of people with dementia |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2022/12/20 13:37:50 |
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Basic information
Public title
Feasibility study of an educational support program for family caregivers of people with dementia
Acronym
Feasibility study of an educational support program for family caregivers of people with dementia
Scientific Title
Feasibility study of an educational support program for family caregivers of people with dementia
Scientific Title:Acronym
Feasibility study of an educational support program for family caregivers of people with dementia
Region
| Japan |
Condition
Condition
Family caregivers of people with dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of an educational support program for family caregivers of dementia patients, consisting of disease education and psycho-education specialized for each type of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
program completion rate
program satisfaction
sense of care burden
Key secondary outcomes
sense of anxiety, depression, loneliness, quality of life
behavioral and psychological symptoms
test of dementia knowledge
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Baseline evaluation
2) Participation in educational support program (approximately once a week for a total of 6 sessions)
3) Reassessment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 years or older
2) Fully understand the content of the research and have the capacity to give consent
3) Caregiver of patient who meets the NINCDS-ADRDA criteria for probable AD as Alzheimer's disease
4) Caregiver of patient who does not live in an institution and have a certain amount of time to contact with the patient
5) Possible to receive the program about once a week
Key exclusion criteria
1) Those with a history of cerebral organic disease, or those suffering from a psychiatric disorder
2) Those with substance-related disorders (e.g., drug dependence)
3) Those who have, or have a history of, a serious illness that makes them unsuitable for participation in this study
4) Suspected moderate or severe hearing loss in both ears
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
0668793051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Suzuki |
Organization
Osaka University United Graduate School of Child Development
Division name
Department of Behavioral Neurology and Neuropsychiatry
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3373
Homepage URL
msuzuki@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, osaka, japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2022 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2022 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056683
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
