Tokyo, April 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061313) titled 'Effectiveness of a Mobile Health App for Increasing Step Counts in Older Adults with Pre-frailty: A Multicenter Trial' on April 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Metropolitan Institute for Geriatrics and Gerontology
Condition:
Condition - Pre-frailty
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study evaluates the effectiveness of the mobile health (mHealth) app "Online Kayoinoba" in increasing step counts among community-dwelling older adults with pre-frailty in Tokyo, Aichi Prefecture, and Shimane Prefecture.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants in the intervention group will receive an intervention designed to support use of the Online Kayoinoba app. First, they will attend one standardized smartphone-use training session. They will then receive eight weekly face-to-face instructional sessions over the 8-week intervention period. At each visit, a specialist will provide a 60-minute lecture on the proper use of the Online Kayoinoba app and its functions. The content will include app installation, how to earn points, the walking function, exercise videos, dietary check, communication functions, health check, and an overall review of these functions. In addition, the same health education provided to the control group will also be delivered. After the intervention period, an approximately 67-week follow-up period will be conducted. During follow-up, a newsletter containing information useful for health and daily living will be mailed every 4 weeks to support continued study participation. In the intervention group, the in-app group chat will also be used once a week after Visit 9 to encourage participants to open the app regularly.
Interventions/Control_2 - Participants in the control group will first receive one smartphone-use training session identical to that provided to the intervention group. They will then attend eight weekly visits over the 8-week intervention period to receive health education. The educational content will cover frailty awareness, exercise, nutrition, sleep, social participation, and a general review related to frailty prevention and management. After the intervention period, participants will enter an approximately 67-week follow-up period. During follow-up, a newsletter containing information useful for health and daily living will be mailed every 4 weeks to support continued study participation. To minimize contamination, face-to-face instructional sessions will be conducted separately for the intervention and control groups.
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - 1. Adults aged 65 years or older at the time of providing informed consent
2. Adults classified as having pre-frailty (score 1-2) based on the revised Japanese version of the Cardiovascular Health Study criteria (J-CHS), assessed within 12 months before informed consent
3. Adults who provide written informed consent to participate in the study
Key exclusion criteria - 1. Individuals who use a smartphone on fewer than 5 days per week
2. Individuals who have been diagnosed with and are receiving treatment for dementia
3. Individuals with a history of, or currently receiving treatment for, neurological disorders such as depression, Parkinson's disease, or stroke
4. Individuals who are currently using the Online Kayoinoba app
5. Individuals unable to undergo physical function testing
6. Individuals with impairment in basic activities of daily living
7. Individuals who have been advised by their primary care physician not to engage in exercise, other than light exercise
8. Individuals who have experienced angina or myocardial infarction within the past 3 months, have a history of cardiac surgery, are receiving palliative care for a terminal illness, or already have plans for surgery or hospitalization during the study period
9. Individuals whom the principal investigator, co-investigators, or study physicians judge to be ineligible for participation in this study
Target Size - 270
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 12 Day
Date of IRB - 2026 Year 02 Month 12 Day
Anticipated trial start date - 2026 Year 04 Month 22 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070154
Disclaimer: Curated by HT Syndication.
