UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on self-management support for persons with early-stage dementia or mild cognitive impairment, and their family members
Title of the study (Brief title)	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	Yohko Maki
Organization	National Center for Geriatrics and Gerontology
Division name	Education and Innovation Center
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	Yohko Maki
Organization	National Center for Geriatrics and Gerontology
Division name	Education and Innovation Center
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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