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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024158
Receipt No. R000027817
Scientific Title The investigation and intervention of both social isolation and self management ability for MCI and dementia patients and their caregivers
Date of disclosure of the study information 2016/09/25
Last modified on 2021/05/03

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Basic information
Public title The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers
Acronym The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients
Scientific Title The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients and their caregivers
Scientific Title:Acronym The investigation and intervention
of both social isolation and self
management ability for MCI and dementia patients
Region
Japan

Condition
Condition MCI , Dementia patients
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to evaluate both social isolation and self management ability for MCI and dementia patients and their caregivers, and establish effective intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Social support questionnaire,
Coping questionnaire
Key secondary outcomes Zarit Caregiver Burden Interview (ZBI)
Mini-Mental State Examination (MMSE)
Neuropsychiatry inventory (NPI)
Quality of Life-Alzheimer's disease(QOL-AD)

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
Medicine 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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria the chief caregiver of MCI and dementia patients, reliable informed consent could be obtained from the patient and or his 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 60

Research contact person
Name of lead principal investigator
1st name Junko
Middle name
Last name Sato
Organization Yagoto hospital
Division name Psychiatry
Zip code 468 00073
Address 1-403 Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL 052-832-2111
Email junko-sa@seirei.ac.jp

Public contact
Name of contact person
1st name Junko
Middle name
Last name Sato
Organization Yagoto hospital
Division name Psychiatry
Zip code 368-0073
Address Shiogamaguchi, Tenpaku-ku, Nagoya-city,Aichi,468-0073,Japan
TEL 052-832-2111
Homepage URL
Email junko-sa@seirei.ac.jp

Sponsor
Institute Yagoto 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 none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Yagoto
Address Yagoto
Tel 052-832-2111
Email hisyo@yagotohp.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 資生会 八事病院 (愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 25 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 20
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason we can not commplete analysis
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
2016 Year 08 Month 31 Day
Date of IRB
2016 Year 09 Month 25 Day
Anticipated trial start date
2016 Year 09 Month 25 Day
Last follow-up date
2018 Year 03 Month 28 Day
Date of closure to data entry
2018 Year 03 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 28 Day
Date analysis concluded
2018 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 25 Day
Last modified on
2021 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027817

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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