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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040655
Receipt No. R000046385
Scientific Title The investigation and intervention of caregivers resilience based on the positive psychology for dementia patients and their caregivers
Date of disclosure of the study information 2020/08/01
Last modified on 2020/06/04

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Basic information
Public title The investigation and intervention
of dementia caregivers based on the positive psychology
Acronym The positive psychology for
dementia caregivers
Scientific Title The investigation and intervention
of caregivers resilience based on the positive psychology for dementia patients and their caregivers
Scientific Title:Acronym The intervention based on the positive psychology for dementia
Region
Japan

Condition
Condition Dementia patients and caregivers
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to evaluate various aspects of caregivers resilience based on the positive psychology for dementia patients and their caregivers, and establish effective new intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PGC Moral Scale
Subjective Well-Being Scale
Key secondary outcomes Zarit Caregiver Burden Interview (ZBI)
Mini-Mental State Examination (MMSE)
Quality of Life-Alzheimer's disease(QOL-AD)
Strength Use Scale (SUS scale)

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 Maneuver
Interventions/Control_1 intervention therapy for caregivers
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
40 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria dementia patients and the chief caregiver of dementia patients, reliable informed consent could be obtained from the patient and or his or her relatives
Key exclusion criteria There was a previous history of mental illness, other findings in terms with the aims of this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shutaro
Middle name
Last name Nakaaki
Organization Minamichita Hospital
Division name Psychiatry
Zip code 470-3411
Address 86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
TEL 0569651111
Email hzi05510@gmail.com

Public contact
Name of contact person
1st name Shutaro
Middle name
Last name Nakaaki
Organization Minamichita Hospital
Division name Psychiatry
Zip code 470-3411
Address 86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
TEL 0569651111
Homepage URL
Email hzi05510@gmail.com

Sponsor
Institute Minamichita Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Yagoto hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of Michamichita Hospital
Address 86 Ooaza Toyookaaza Magohazama,Chita-gun , Minamichita-cho,Aichi,470-3411,Japan
Tel 0569 65 1111
Email hzi05510@gmail.com

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 南知多病院 (愛知県)

Other administrative information
Date of disclosure of the study information
2020 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
2019 Year 04 Month 30 Day
Date of IRB
2019 Year 05 Month 16 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 04 Day
Last modified on
2020 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046385

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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