UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018988 |
|---|---|
| Receipt number | R000021962 |
| Scientific Title | Verification of the effects of a comprehensive educational program for carers of people living with dementia, by cross-over design |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2019/02/04 15:56:17 |
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Basic information
Public title
Verification of the effects of a comprehensive educational program for carers of people living with dementia, by cross-over design
Acronym
Verification of the effects of a comprehensive educational program for carers of people living with dementia
Scientific Title
Verification of the effects of a comprehensive educational program for carers of people living with dementia, by cross-over design
Scientific Title:Acronym
Verification of the effects of a comprehensive educational program for carers of people living with dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We verified the effects of the comprehensive education program (CEP: a configuration with medical, dementia care-related, psychological, and social welfare-related domains, with multidisciplinary instruction and the introduction of interactive exercises )for carers of people living with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The stress responses <1:Depression(The Center for Epidemiologic Studies Depression Scale; CES-D),2:Burn-out(Pines Burnout Measurement-Japanese version; BM-J)>.
There was then an investigation of the outcomes of the present study: study subjects took a total of four self-reported questionnaires per person, at the start of the first term (Time1) and three months later(Time2), as well as at the start of the second term(Time3) and three months later(Time4).
Key secondary outcomes
3:Care coping <The Family Crisis Oriented Personal Evaluation Scale; F-Copes>,
4:Cognitive Care-giving Appraisal
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
<Course A:Start group from the CEP>
Participating in the CEP:Before (Time1), After 3 months(Time2)
Interventions/Control_2
<Course A:Start group from the CEP>
After Time2, Carry over:1month, Self-study: Before(Time3),After 3 months(Time4)
Interventions/Control_3
<Course B: Start group from the control group>
Self-study with dementia care pamphlet:
Before(Time1),After 3 months(Time2)
Interventions/Control_4
<Course B: Start group from the control group>
After Carry over:1 month, Participating in the CEP: Before(Time3),After 3months(Time4)
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
The subjects of the present study were carers of people whose dementia is in the process of progressing, during attendance of the Memory Clinic of Japan's National Center for Geriatrics and Gerontology. Those carers who met the following three study criteria received a verbal and written explanation of the study intent and purpose, and gave consent to participate in the study. The study criteria were - 1: 3 years or more have passed since a definitive diagnosis of dementia; 2: carers currently providing at-home care for a person living with dementia; 3: people who are carers, and who are not professional caregivers.
Key exclusion criteria
1: Carers are long-term care profession.
2: People with dementia are living in a care home.
3: People with dementia's diagnosis are the early stage of dementia or MCI.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Seike |
Organization
1:National Center for Geriatrics and Gerontology,2:Kyoto University
Division name
1:The Center for Comprehensive Care and Research on Memory Disorders,2: Kokoro research center
Zip code
Address
46 Shimoadachi-cho,Yoshida,Sakyo-ku,Kyoto 606-8501 JAPAN
TEL
075-753-9670
seike.aya.6u@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rina Honda |
Organization
National Center for Geriatrics and Gerontology
Division name
The division of medical research consultation
Zip code
Address
7-430,Morioka-cho,Ohbu City,Aichi
TEL
0562-46-2311
Homepage URL
honda-r@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
The Center for Comprehensive Care and Research on Memory Disorders
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 16 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021962
| 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 |
