- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270121
Development of a Healthcare Service Platform for Successful Aging
Development of an Integrated Contactless Healthcare Service Platform Based on Intelligent IoT for the Successful Aging of the Elderly
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sunmi Song, PhD
- Phone Number: +821087489593
- Email: sunmi.song0715@gmail.com
Study Contact Backup
- Name: Junesun Kim, PhD
- Phone Number: +821052110106
- Email: junokim74@korea.ac.kr
Study Locations
-
-
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Seoul, Korea, Republic of, 02841
- Recruiting
- Korea University
-
Contact:
- Sunmi Song, PhD
- Phone Number: +821087489593
- Email: sunmi.song0715@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Living-lab digital intervention group
Digital devices (wearable and motion sensor) and mobile application will be utilized to monitor mental and physical health status and provide daily individualized health status information to an older adult user and their community and family caregivers.
The older adult users are also asked to participate in pre-mid-post surveys to evaluate health, usability, effectiveness, and safety of the developed platform service.
|
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.
|
No Intervention: Control group
The participated in the control group are asked to participate in pre-mid-post surveys to evaluate health status.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Daily assessments across 6 weeks
|
PHQ-9 items will be used to assess daily depressive symptoms using a chatbot, the total score ranged from 0 to 27, higher score representing more severe depressive status.
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Daily assessments across 6 weeks
|
Sleep fragmentation index
Time Frame: Daily assessments across 6 weeks
|
Number of awakening divided by total sleep time in percentage, ranged from 0 to 100, higher score indicating more fragmented sleep.
|
Daily assessments across 6 weeks
|
Daily steps
Time Frame: Daily assessments across 6 weeks
|
Number of steps per day, which can be ranged from 0 to infinite.
Higher numbers of steps indicate more physical activity for the day.
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Daily assessments across 6 weeks
|
Intensity of physical activity
Time Frame: Daily assessments across 6 weeks
|
Minutes of light, moderate, and intense physical activity, which can be ranged from 0 to 1440 minutes.
More active minutes at each of the three intensity levels presents more physical activities.
|
Daily assessments across 6 weeks
|
Heart rate variability
Time Frame: Daily assessments across 6 weeks
|
Daily assessments of heart rate variability
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Daily assessments across 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geriatic depression
Time Frame: Before and after the 6 week living lab periods
|
Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms.
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Before and after the 6 week living lab periods
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SF-12 Quality of life
Time Frame: Before and after the 6 week living lab periods
|
Short Form survey-12 (SF-12) measures levels of the health related quality of life, which ranges from 0 to 100 with higher scores presenting better quality of life.
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Before and after the 6 week living lab periods
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Pain related functional limitations
Time Frame: Before and after the 6 week living lab periods
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which ranged from 0 to 90 with higher scores indicating worse pain related functional limitations in one's daily living.
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Before and after the 6 week living lab periods
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Chronic pain
Time Frame: Before and after the 6 week living lab periods
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Brief Pain Inventory (BPI) score ranges from 1 to 10 with higher score indicating more severe pain.
|
Before and after the 6 week living lab periods
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junesun Kim, PhD, Korea University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R2111483
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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