UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047610 |
|---|---|
| Receipt number | R000054293 |
| 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 |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2022/04/27 23:01:40 |
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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
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
shiozawa@snl.jp
Sponsor or person
Institute
Safety Net Linkage, a general incorporated association
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054293
