UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062907 |
|---|---|
| Receipt number | R000071447 |
| Scientific Title | Evaluation of the Effectiveness of a Health-support App for Older Adults at Risk of Frailty |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 10:01:19 |
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Basic information
Public title
Genki Project on Smartphones
Acronym
Sma-Pro
Scientific Title
Evaluation of the Effectiveness of a Health-support App for Older Adults at Risk of Frailty
Scientific Title:Acronym
Health-support App Study
Region
| Japan |
Condition
Condition
Older people
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the effectiveness of using a digital peer-supported app on frailty-related outcomes among community-dwelling older adults with prefrailty or frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty-related measures (physical function, body composition, cognitive function, psychological function, and social aspects)
Key secondary outcomes
App retention and adherence rates; frailty measures (J-CHS, KCL, and QMCOO); and physical activity.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Receiving health information once a month and using the digital peer-support app daily for six months.
Interventions/Control_2
Receiving health information once a month for six months.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who provided written informed consent to participate.
Individuals aged 65 years or older at the time of obtaining consent, regardless of sex.
Individuals classified as prefrail or frail, with a score of 4 or higher on the Kihon Checklist (KCL) at the time of consent.
Individuals who owned a smartphone at the time of obtaining consent.
Key exclusion criteria
Individuals currently undergoing exercise or dietary therapy under a physician's supervision.
Individuals for whom exercise is contraindicated by a physician due to conditions such as heart disease, cerebrovascular disease, respiratory disease, kidney disease, or malignant tumors.
Individuals with current or past drug or alcohol dependence.
Individuals currently receiving treatment for mental disorders (e.g., depression) or sleep disorders, or with a history of mental illness.
Individuals with extremely irregular dietary, sleep, or other lifestyle habits or routines.
Individuals using a pacemaker.
Individuals who participated in another clinical trial or research study within three months before the date of consent, or who plan to participate in another clinical trial or research study during the study period.
Individuals who may have difficulty complying with recording requirements for the various questionnaires.
Individuals unable to enter text on a smartphone.
Individuals already using the peer-support application employed in this study.
Individuals otherwise deemed unsuitable for participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Tabira |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL
08027340209
kentotabira@gmail.com
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Tabira |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
8908544
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima
TEL
08027340209
Homepage URL
kentotabira@gmail.com
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Kento Tabira
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
A10 Lab Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima university medical and dental hospital clinical research management center
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima
Tel
0992756624
crmc@m2.kufm.kagoshima-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
| 2026 | Year | 09 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2026 | Year | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071447
