UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057861 |
|---|---|
| Receipt number | R000064064 |
| Scientific Title | Effectiveness of behavioral change intervention using health apps on cognitive function and well-being in community-dwelling older adults: A prospective cohort study |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/14 15:07:35 |
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Basic information
Public title
A study on the effects of behavioral changes through health apps on cognitive function and well-being in older adults
Acronym
Effects of health apps on cognitive function and well-being in older adults
Scientific Title
Effectiveness of behavioral change intervention using health apps on cognitive function and well-being in community-dwelling older adults: A prospective cohort study
Scientific Title:Acronym
A prospective study on the effects of health app intervention on cognitive function and well-being in older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to capture changes in cognitive function and social participation over time through an intervention using a health app to induce behavioral change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (Cogstate Brief Battery Japanese version)
Key secondary outcomes
Health-related QOL (EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Healthcare Applications
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Living or working in Kobe City
(2) Owns a smartphone
Key exclusion criteria
(1) Have an injury or illness that makes it difficult to walk
(2) Currently a member of Sumitomo Life Insurance Company's "Vitality"
(3) Participants in other intervention studies or projects involving physical activity
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Akisue |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-Ku, Kobe, Hyogo
TEL
078-796-4596
akisue@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Sonoda |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-Ku, Kobe, Hyogo
TEL
078-796-4651
Homepage URL
yuma@dragon.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Life Insurance Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences Ethics Committee
Address
7-10-2 Tomogaoka, Suma-Ku, Kobe, Hyogo
Tel
078-796-4502
syomu2@ams.kobe-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 14 | 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
467
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
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064064
