Depression in Old AgeNCT06270121
Development of a Healthcare Service Platform for Successful Aging
A study testing Living-lab digital intervention group in people with Depression in Old Age and Chronic Pain, run by Sunmi Song at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Old Age, Chronic Pain, Sleep Disorder Insomnia Chronic
- What is being tested?
- Living-lab digital intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2020to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community dwelling older adults who are 65 years old and older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University
Seoul, 02841
Sunmi Song, PhD, +821087489593, sunmi.song0715@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Living-lab digital intervention group
- Keywords
- geriatric depression, digital mental health phenotyping, community based hybrid digital senior care service, digital healthcare monitoring platform for elderly, chronic pain, sleep disorders
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living-lab digital intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Living-lab digital intervention group | Experimental | 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. Receives: Behavioral: Living-lab digital intervention group |
| Control group | No intervention | The participated in the control group are asked to participate in pre-mid-post surveys to evaluate health status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Daily assessments across 6 weeks
Sleep fragmentation index
Number of awakening divided by total sleep time in percentage, ranged from 0 to 100, higher score indicating more fragmented sleep.
Measured: Daily assessments across 6 weeks
Daily steps
Number of steps per day, which can be ranged from 0 to infinite. Higher numbers of steps indicate more physical activity for the day.
Measured: Daily assessments across 6 weeks
Intensity of physical activity
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.
Measured: Daily assessments across 6 weeks
Heart rate variability
Daily assessments of heart rate variability
Measured: Daily assessments across 6 weeks
Secondary outcomes (4)
Geriatic depression
Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms.
Measured: Before and after the 6 week living lab periods
SF-12 Quality of life
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.
Measured: Before and after the 6 week living lab periods
Pain related functional limitations
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.
Measured: Before and after the 6 week living lab periods
Chronic pain
Brief Pain Inventory (BPI) score ranges from 1 to 10 with higher score indicating more severe pain.
Measured: Before and after the 6 week living lab periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start21 Oct 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunmi Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sunmi Song, Korea University
- Investigators
- Junesun Kim, PhD, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270121
- Sponsor's protocol ID
- R2111483
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 42061838Song 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.
PubMed 38885033
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Integrated Contactless Healthcare Service Platform Based on Intelligent IoT for the Successful Aging of the Elderly
- ClinicalTrials.gov ID
- NCT06270121
- Acronym / sponsor ID
- R2111483
- Keywords
- geriatric depression, digital mental health phenotyping, community based hybrid digital senior care service, digital healthcare monitoring platform for elderly, chronic pain, sleep disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sunmi SongUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living-lab digital intervention group | Experimental | Behavioral: Living-lab digital intervention groupDigital 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. |
| Control group | No intervention | –The participated in the control group are asked to participate in pre-mid-post surveys to evaluate health status. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community dwelling older adults who are 65 years old and older
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living-lab digital intervention groupOlder 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. | Behavioural | Living-lab digital intervention group |
Primary outcome
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.
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 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.
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.
Heart rate variability
Time frame: Daily assessments across 6 weeks
Daily assessments of heart rate variability
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 42061838Song 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.
- Derived from this study: PubMed 38885033Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junesun Kim, PhD principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living-lab digital intervention group in people with Depression in Old Age and Chronic Pain, run by Sunmi Song at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunmi Song, PhD (+821087489593, sunmi.song0715@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Daily assessments across 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270121, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.