Development of a Healthcare Service Platform for Successful Aging

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270121
• Other study ID #: R2111483
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: November 30, 2030

Study information

• Verified date: February 2024
• Source: Korea University
• Contact: Sunmi Song, PhD
• Phone: +821087489593
• Email: sunmi.song0715[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 30, 2030
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depression in Old Age
• Parasomnias
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sunmi Song

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Daily assessments across 6 weeks
Primary	Sleep fragmentation index	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
Primary	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.	Daily assessments across 6 weeks
Primary	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.	Daily assessments across 6 weeks
Primary	Heart rate variability	Daily assessments of heart rate variability	Daily assessments across 6 weeks
Secondary	Geriatic depression	Geriatric depression scale score ranges from 0-15 with higher scores indicating more severe depressive symptoms.	Before and after the 6 week living lab periods
Secondary	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.	Before and after the 6 week living lab periods
Secondary	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.	Before and after the 6 week living lab periods
Secondary	Chronic pain	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