Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062907) titled 'Genki Project on Smartphones' on Sept. 14.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kagoshima University
Condition:
Condition - Older people
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071447
Disclaimer: Curated by HT Syndication.
