Menu
Recruiting NCT06270121

Development of a Healthcare Service Platform for Successful Aging

No phase Interventional Depression in Old Age Chronic Pain Sleep Disorder Insomnia Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Living-lab digital intervention group.
Who it may be relevant to
Registry conditions: Depression in Old Age, Chronic Pain, Sleep Disorder Insomnia Chronic. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development of an Integrated Contactless Healthcare Service Platform Based on Intelligent IoT for the Successful Aging of the Elderly

Overview

The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are: * Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults * Develop digital health monitoring service to inform individualized daily health status of older adults users * Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information. Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers. If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group.

Detailed description

The purpose of the living-lab clinical trials is to develop contactless digital health monitoring system and individually customizable health status feedback contents in order to improve self-care capacity and mental health of older adults who live alone. Also, the current trials aim to evaluate effectiveness and usability of the overall developed monitoring platform. The effectiveness evaluation will investigate whether the platform can be effective at detecting levels of health decline or improvements and connecting in-person healthcare services. The usability tests will focus on user-centeredness, efficiency, and usability for older adults and their community healthcare provider.

To accomplish the purposes, the platform was developed based on needs assessments and observations of living environments of community dwelling older adults using surveys and interviews. Community healthcare providers also participated interview on their needs as a caregiver and working conditions that need to be considered to develop applications and website for community caregivers.

The developed platform will be tested by younger adults for a pilot test and be tested by older adult users and their matched controls for the main clinical trials. The older adults participants will be recruited via postings and study information sessions at the community senior welfare center in Seoul, South Korea. Interested older adults and community healthcare service providers will be invited to participation in the trials. After recruiting the living lab older adults, age and gender matched control older adults will be recruited. Older adult participants will be those who are over 65 years old and do not have cognitive and sensory disorders (e.g., deafness or dementia) that may inhibit participation in the trials.

The living lab will be conducted for 6 weeks, starting with a 1-week adaptation period. Older adults will be asked to open the smartphone application in the morning; the application would automatically link them to a chatbot asking how they are doing and 2 questions on daily depressive symptoms.

After using the chatbot, the participants will be able to see their daily health status information for stress (via high frequency measure (HF) of heart rate variability (HRV)), sleep (via total sleep time and sleep fragmentation), and physical activity (via steps) on the previous day, compared to their own average during the first week of the living lab.

Their voice records and daily health status will be sent to their matched community caregiver via a study website. A manager at the senior welfare center will be able to monitor any health emergency by participated older adults via the study website.

During the living lab period, the older adult participants will be asked to wear a smartwatch continuously except while the battery is being charged. For the effectiveness and usability evaluations, both living lab and control participants will be invited to surveys before, during, and after the 6 week periods. Community caregivers and managers will evaluate the effectiveness and usability via a survey and interview after the 6 week living lab period.

Interventions

  • Behavioral Living-lab digital intervention group
    Older adults will receive individualized daily health feedback via the mobile applications, which will be shared with caregivers. They will also receive support for health emergency by the platform sending automatic emergency push alarm to community and family caregivers.

Primary outcome measures

  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Daily assessments across 6 weeks]
  • Sleep fragmentation index [Time frame: Daily assessments across 6 weeks]
  • Daily steps [Time frame: Daily assessments across 6 weeks]
  • Intensity of physical activity [Time frame: Daily assessments across 6 weeks]
  • Heart rate variability [Time frame: Daily assessments across 6 weeks]
Secondary outcome measures (4)
  • Geriatic depression [Time frame: Before and after the 6 week living lab periods]
  • SF-12 Quality of life [Time frame: Before and after the 6 week living lab periods]
  • Pain related functional limitations [Time frame: Before and after the 6 week living lab periods]
  • Chronic pain [Time frame: Before and after the 6 week living lab periods]

Eligibility criteria

Inclusion criteria

  • Community dwelling older adults who are 65 years old and older

Exclusion criteria

  • Older adults with cognitive, sensory, and functional problems that may hinder them from participating surveys.
  • Older adults with iOS mobile device that would not allow them to use the developed mobile application.
  • Older adults in nursing home or who are hospitalized because this platform is designed to support independent living of an older adults in their home.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Korea University — Seoul

Publications

  • Song S, Hwang SY, Kim HY, Kim J. Digital-Human Public Community Care Integration for Chronic Pain in Low-Income Older Adults in a 6-Week Living Lab Setting: Quasi-Experimental Feasibility Study. JMIR Aging. 2026 Apr 20;9:e85611. doi: 10.2196/85611. PMID 42061838
  • Song S, Seo Y, Hwang S, Kim HY, Kim J. Digital Phenotyping of Geriatric Depression Using a Community-Based Digital Mental Health Monitoring Platform for Socially Vulnerable Older Adults and Their Community Caregivers: 6-Week Living Lab Single-Arm Pilot Study. JMIR Mhealth Uhealth. 2024 Jun 17;12:e55842. doi: 10.2196/55842. PMID 38885033

Identifiers

NCT: NCT06270121 · R2111483

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗