UMIN-CTR Clinical Trial

Basic information
Public title	Research on changes in the quality of life of people with dementia at home and their families using the Community Coexistence Support App (Mimamoriai App).
Acronym	QOL survey of people with dementia (including family members) using the Mimamoria app.
Scientific Title	Non-randomised crossover comparative study of the effectiveness of the Community Symbiosis Support App (Mimamoriai App) in improving the quality of life of people with early dementia (including MCI and young-onset dementia) and their families at home
Scientific Title:Acronym	Non-randomised crossover controlled trial on the effect of quality of life improvement in people with dementia (including family members).
Region	Japan

Condition
Condition	Dementia Mild Cognitive Impairment
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to "provide a new place (on voice SNS) for people with dementia and their families to be able to support them after the onset of dementia, gather the information and people they need, and prevent loneliness and isolation while staying close to the process of loss". And with the ultimate goal of building a comprehensive community care system to realise "restoration of connection with society (real places, roles, things they want to do, etc.)" at their own pace, this research aims to assess the QOL of people with dementia and their families using objective tools and to use the "Community Symbiosis Support App (Mimamoriai App)" to The objective is to clarify the extent to which the QOL of people with dementia and their families can be improved by using the MIMAMORIAI App. Translated with www.DeepL.com/Translator (free version)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EQ-5D-5L
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The intervention group will access the app about once a week for one month to check the content of the audio or article information in the group information distribution they receive; after one month, they will complete an in-app questionnaire to assess their quality of life and a shortened version of the loneliness scale (3 items).
Interventions/Control_2	For the control group, the research organisation concerned will convert the leaflets and other materials it normally provides into PDFs and deliver the information within the app. One month later, a questionnaire will be administered in the app to assess QOL and a shortened version of the loneliness scale (3 items).
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient Persons with early-stage dementia (including MCI and juvenile dementia) aged 20 years or older at the time consent is obtained. Cases with early-stage dementia who spend time at home and own a smartphone. Cases in which written consent for participation in the study has been obtained. Family members Family members who live with a person with dementia (including MCI and juvenile dementia) and are aged 20 years or older when consent is obtained. Family members who live at home and own a smartphone. Families who have given written consent to participate in the study. Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria	Patient Cases with no diagnosis of dementia (including MCI and juvenile dementia) Cases with moderate or severe symptoms of dementia. Cases with a history of head injury, drug or alcohol abuse. Cases with a diagnosis of intellectual disability. Cases in which it is impossible to carry out this study due to visual or auditory impairment or aphasia. Cases in which conversation in Japanese is impossible. Cases in which consent for participation cannot be obtained. Cases in which the patient's family cannot give consent to participate. Family Family members who do not live with the person with dementia (including MCI and juvenile dementia) Families with a history of head injury, drug or alcohol abuse Families with a diagnosis of intellectual disability. Families who are unable to carry out this study due to visual or hearing impairment or aphasia. Families who are unable to speak Japanese. Families who cannot give consent to participate in the study. Translated with www.DeepL.com/Translator (free version)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Miyae Middle name Last name Yamakawa
Organization	Osaka University
Division name	Health Science
Zip code	5850871
Address	1 7 Yamadaoka Suita city
TEL	0668792543
Email	miyatabu@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takumi Middle name Last name Shiozawa
Organization	Safety Net Linkage, a general incorporated association
Division name	None
Zip code	005-0832
Address	1-11-41, Kitanosawa, Minami-ku, Sapporo, Hokkaido
TEL	090-9173-3578
Homepage URL
Email	shiozawa@snl.jp

Sponsor
Institute	Safety Net Linkage, a general incorporated association
Institute
Department

Funding Source
Organization	Safety Net Linkage, a general incorporated association METI(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Safety Net Linkage, a general incorporated association
Address	1-11-41, Kitanosawa, Minami-ku, Sapporo, Hokkaido
Tel	090-9173-3578
Email	shiozawa@snl.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	①浅香山病院(大阪府) ②京都府立医科大学付属病院(京都府)

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 28 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	2022 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 02 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 27 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054293