UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026555 |
|---|---|
| Receipt number | R000030492 |
| Scientific Title | The investigation of the effect of educational program on the caregiver of a dementia patient |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2018/03/14 20:14:00 |
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Basic information
Public title
The investigation of the effect of educational program on the caregiver of a dementia patient
Acronym
The investigation of the effect of educational program on the caregiver of a dementia patient
Scientific Title
The investigation of the effect of educational program on the caregiver of a dementia patient
Scientific Title:Acronym
The investigation of the effect of educational program on the caregiver of a dementia patient
Region
| Japan |
Condition
Condition
Alzheimer's disease patients and their caregivers
Classification by specialty
| Hematology and clinical oncology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the change of the information about emotion and living of caregivers of Alzheimer's disease patients by the education program using our original booklet or a control booklet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the interaction between the difference booklets for educational program and the changes of the information about emotion and living of caregivers after a month of the educational program.
Key secondary outcomes
We investigate the relationships between the changes of the information about emotion and living of caregivers after a month of the educational program, and demographic data, neurocognitive/ neuropsychological tests results, and MRI data of Alzheimer's disease patients in clinical use.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The educational program about dementia using our original booklet is performed once.
Interventions/Control_2
The educational program about dementia using a control booklet is performed once.
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) "Primary caregiver" of the outpatients in the psychiatric department of Nara medical university or Nara medical university hospital dementia-related disease medical center who are diagnosed as Alzheimer's disease based on DSM-5, asking for educational program about dementia. In the present study, we regarded relatives performing caregiving primarily and having an intimate knowledge of the patients developed over time, as "primary caregivers".
b) No history or present diagnosis of any DSM-5 diagnosis or any neurological illness.
c) The Alzheimer's disease patients of "primary caregivers" have the consent ability and consent to the application of their demographic data, neurocognitive/ neuropsychological tests results, and MRI data for the present study.
d) >= 18 years of age
Key exclusion criteria
a) A history of head injury
b) A diagnose of abuse or addiction of drugs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiwamu Matsuoka |
Organization
Nara medical university
Division name
The department of psychiatry
Zip code
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
kiwamu@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiwamu Matsuoka |
Organization
Nara medical university
Division name
The department of psychiatry
Zip code
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kiwamu@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university
Institute
Department
Personal name
Funding Source
Organization
NIPPON LIFE INSURANCE FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
奈良県立医科大学付属病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 21 | 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 | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030492
