Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059741) titled 'Development of a Comprehensive Health Advice Generation and Health Counseling Support System' on Nov. 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Frailty
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to develop and implement a comprehensive health advice generation and health guidance support system suitable for installation in elderly care facilities and to verify its usefulness. Medical-grade measuring devices are used to conduct multifaceted assessments of physical function, cognitive function, sleep, and mental health, and a proprietary algorithm is used to automatically generate personalized comprehensive health advice. This advice does not complete health guidance on its own; rather, it is presented in conjunction with an interview support tool, helping to streamline and focus individual interviews by public health nurses.
The primary outcome to be verified in this study is satisfaction with public health nurse interviews. We will determine whether the introduction of an advice and interview support system can shorten interview time even with limited professional resources while providing support that is convincing to the recipient. Furthermore, we will secondary-assess the feasibility of on-site implementation by evaluating advice comprehension, willingness to change behavior, and tool usability. Through these efforts, this study aims to demonstrate the nature of sustainable and efficient health guidance in a super-aging society and lay an important foundation for both scientific and social success.
This study is based on a comprehensive intervention model implemented in previous research, and will introduce a portable configuration using existing equipment and AI support tools to optimize its operation.The purpose is not to compare with a non-intervention group, but to primarily examine the usefulness of information organization and promotion of understanding in comprehensive intervention.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention in this study consists of a series of steps: surveys and measurements, the presentation of automatically generated advice (assistance tools), and individual interviews with public health nurses. Specifically, subjects undergo non-invasive assessments such as grip strength, walking speed, body composition, simple tests of cognitive function, simple scales for depression and insomnia, and sleep monitoring. Based on these measurement data, a research algorithm automatically generates comprehensive health advice. This advice is presented to subjects using a tablet or PC, and then the public health nurse conducts an individual interview based on the advice. The interview is focused according to the subject's level of understanding and motivation, and the required time is limited to approximately 20 minutes. The entire procedure is considered a single intervention and will be carried out once for each subject. No medication or invasive procedures are involved.
Eligibility:
Age-lower limit - 60
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Facility users residing in the facility
(Criteria for facility use include being able to walk independently and being 60 years of age or older)
2.Individuals who can provide written consent to participate in the study
Key exclusion criteria - 1.Subjects with significant visual or hearing impairments that make it difficult to take measurements or operate tools
2.Subjects deemed ineligible by the principal investigator
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 11 Day
Anticipated trial start date - 2025 Year 11 Month 20 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068318
Disclaimer: Curated by HT Syndication.