UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049045 |
|---|---|
| Receipt number | R000055781 |
| Scientific Title | The Efficacy of a Smartphone App in Promoting Social Participation of Older People |
| Date of disclosure of the study information | 2022/10/15 |
| Last modified on | 2023/10/12 14:50:45 |
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Basic information
Public title
The Efficacy of a Smartphone App in Promoting Social Participation on Older People
Acronym
The Efficacy of a Smartphone App in Promoting Social Participation of Older People
Scientific Title
The Efficacy of a Smartphone App in Promoting Social Participation of Older People
Scientific Title:Acronym
The Efficacy of a Smartphone App in Promoting Social Participation of Older People
Region
| Japan |
Condition
Condition
ADL and IADL disabilities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine whether a social participation app can promote social participation among older people.
We will also examine whether the app can improve physical activity and subjective well-being by promoting social participation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The number of social participation per month 12 weeks after consent to participate in the study
The average number of steps 12 weeks after consent to participate in the study
Key secondary outcomes
Number of social participation by type per month 12 weeks after consent to participate in the study
Intention to participate in social activities 12 weeks after consent to participate in the study
Average walking time 12 weeks after consent to participate in the study
Subjective wellbeing 12 weeks after consent to participate in the study
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of an app that promotes social participation
Interventions/Control_2
No use of a social participation app
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who are using a smartphone when consent is obtained
(2) Those who are using LINE when consent is obtained
(3) Those who can communicate in Japanese
(4) Those who are not certified as requiring support or nursing care
(5) Those who have obtained consent for participation in the research from the research subjects themselves online
Key exclusion criteria
(1) Senior smartphone users
(2) Tablet users
(3) Those who cannot give consent to the survey research
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University/Japan Agency for Gerontological Evaluation Study/National Center for Geriatrics and Gerontology
Division name
Center for Preventive Medical Sciences/-/Center for Gerontology and Social Science
Zip code
263-8522/110-0001/474-8511
Address
1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan/ 6-3-5 Yanaka Taito-ku Tokyo 110-0001 Japan/ 7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511 Japan
TEL
03-6206-0865
team-kk@jages.net
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Kondo |
Organization
Japan Agency for Gerontological Evaluation Study
Division name
-
Zip code
110-0001
Address
6-3-5 Yanaka Taito-ku Tokyo 110-0001 Japan
TEL
03-6206-0865
Homepage URL
umin-ctr@jages.net
Sponsor or person
Institute
Japan Agency for Gerontological Evaluation Study
Institute
Department
Personal name
Funding Source
Organization
RISTEX
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi, Ltd.
Name of secondary funder(s)
Hitachi, Ltd.
IRB Contact (For public release)
Organization
Research ethics committee of Japan Agency for Gerontological Evaluation Study
Address
1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan
Tel
03-6206-0865
umin-ctr@jages.net
Secondary IDs
Secondary IDs
YES
Study ID_1
M10564
Org. issuing International ID_1
Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 15 | 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
192
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055781
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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