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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018988
Receipt No. 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

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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
Email 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
Email honda-r@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
The Center for Comprehensive Care and Research on Memory Disorders
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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