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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034260
Receipt No. R000039055
Scientific Title Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members
Date of disclosure of the study information 2018/09/25
Last modified on 2018/11/20

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Basic information
Public title Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members
Acronym Research on self-management support for persons with dementia or MCI, and their families
Scientific Title Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members
Scientific Title:Acronym Research on self-management support for persons with dementia or MCI, and their families
Region
Japan

Condition
Condition Alzheimer's disease dementia, Mild cognitive impariment
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To propose an empowerment intervention for persons with early-stage Alzheimer's disease dementia or Mild cognitive impairment, and their family members after diagnosis, and to verify the efficacy of the intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sense of Coherence Scale (SOC-13)
(after the 10-week interventions)
Key secondary outcomes Japanese version of WHO-Five well-being index
Japanese version of Multidimensional Scale of Perceived Social Support
Japanese version of Herth Hope Index
Japanese version of the Gratitude Questionnaire
Japanese version of the UCLA Loneliness Scale Version 3
Japanese version of NPI (Neuropsychiatric Inventory) -Q
The short version of the Japanese version of the Zarit Burden Interview (J-ZBI_8).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Weekly one-hour interventions of the group meetings of the patients and their family members at the National Center for Geriatrics and Gerontology.
Home work done by the patients and their family members during the intervention period.
Interventions/Control_2 Home work done by the patients and their family members during the intervention period.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patients diagnosed as mild cognitive impairment due to Alzheimer's disease or Alzheimer's disease dementia.
-Total scores of Mini-Mental Scale Examination (MMSE): 20 or more
-Possible to communicate in language.
-Patients who can attend the intervention with the main caregivers.
Key exclusion criteria -Patients diagnosed as mild cognitive impairment due to Lewy Body Disease, or Frontotemporal Dementia.
-Patients diagnosed as psychiatric diseases other than mild cognitive disease or dementia.
-Difficult to communicate in language (e.g., aphasia)
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohko Maki
Organization National Center for Geriatrics and Gerontology
Division name Education and Innovation Center
Zip code
Address 7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL 0562-46-2311
Email maki-yk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohko Maki
Organization National Center for Geriatrics and Gerontology
Division name Education and Innovation Center
Zip code
Address 7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL 0562-46-2311
Homepage URL
Email maki-yk@umin.ac.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2018 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
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
2018 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 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
2018 Year 09 Month 25 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039055

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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