UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054131 |
|---|---|
| Receipt number | R000061812 |
| Scientific Title | Effects of mobile health (mHealth) apps on frailty phenotype scores for older adults with frailty: An exploratory preliminary trial. |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2024/04/12 11:50:45 |
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Basic information
Public title
Effects of mobile health (mHealth) apps on frailty phenotype scores for older adults with frailty: An exploratory preliminary trial.
Acronym
Effects of mobile health (mHealth) apps on frailty phenotype scores for older adults with frailty: An exploratory preliminary trial.
Scientific Title
Effects of mobile health (mHealth) apps on frailty phenotype scores for older adults with frailty: An exploratory preliminary trial.
Scientific Title:Acronym
Mobile Health (mHealth) Apps on Frailty Phenotype Scores Preliminary Trial
Region
| Japan |
Condition
Condition
Pre-frailty
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study quantifies the effect size on frailty phenotype scores and tests the program feasibility of a quasi-remote health support program utilizing the mobile health (mHealth) application "Online Kayoinoba" for older adults with pre-frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change in frailty phenotype scores from baseline to the end of the 24-week intervention
Key secondary outcomes
1). Physical activity
2). Physical function
3). Cognitive function
4). Quality of life
5). Social isolation
6). Mental health
7). Dietary balance
8). Comprehensive self-health check
9). Gait parameters
10). Adverse events
11). Adherence
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
Intervention group
Lectures on how to use the mobile health application (Online kayoinoba) will be provided once a week for 60 minutes, a sum of 6 sessions (6 weeks).
Lecture on health education including preventive caregiving once a week for 30 minutes, a sum of 6 sessions.
Interventions/Control_2
Control group
Lecture on health education including preventive caregiving once a week for 30 minutes, a sum of 6 sessions.
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
1. Age 65 years or older
2. Pre-frail (1-2 points) according to J-CHS revised version
3. Smartphone users
4. Those who can provide written consent for participation in the study
Key exclusion criteria
1. Those who have been diagnosed with dementia
2. Those who are taking medication for dementia
3. Those who are participating in other studies using mobile health apps conducted at our center
4. Those who are unable to undergo tests such as motor function tests.
5. Those who are unable to perform basic activities of daily living.
6. Those who are prohibited from exercising (except light exercise) by physicians
7. Those who have unstable or severe medical conditions that do not allow them to participate in the study by the study physician.
8. Those who have had angina pectoris or myocardial infarction within the past 3 months or have had previous cardiac surgery, are terminally ill or are receiving palliative care.
9. Those deemed ineligible by the principal investigator or the study physician to participate in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Ohta |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
t_ohta@tmig.or.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Ohta |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
t_ohta@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
1. The 38th Research Grant from the Meiji Yasuda Life Foundation of Health
2. Longevity Sciences from the National Center for Geriatrics and Gerontology, Japan (grant numbers 24-2)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tokyo Metropolitan Geriatric Hospital and Institute for Geriatrics and Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
| 2024 | Year | 04 | Month | 12 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061812
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| Registered date | File name |
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