Development of a Healthcare Service Platform for Successful Aging

NCT06270121 | Recruiting

• 1 other identifier: R2111483
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression in Old Age; Chronic Pain; Sleep Disorder Insomnia Chronic

Keywords

geriatric depression; digital mental health phenotyping; community based hybrid digital senior care service; digital healthcare monitoring platform for elderly; chronic pain; sleep disorders

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Heart rate variability

  Daily assessments of heart rate variability

  Daily assessments across 6 weeks

Secondary Outcomes (4)

• Geriatic depression

  Before and after the 6 week living lab periods

• SF-12 Quality of life

  Before and after the 6 week living lab periods

• Pain related functional limitations

  Before and after the 6 week living lab periods

• Chronic pain

  Before and after the 6 week living lab periods

Study Arms (2)

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.

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.

Interventions

Living-lab digital intervention group BEHAVIORAL

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.

Living-lab digital intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunmi Song: lead

Study Sites (1)

Korea University

Seoul, 02841, South Korea

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders

Study Officials

• Junesun Kim, PhD

  Korea University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunmi Song, PhD

CONTACT

+821087489593; sunmi.song0715@gmail.com

Junesun Kim, PhD

CONTACT

+821052110106; junokim74@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Control group was informed that they participated in the study with a repeated measure survey about digital healthcare for elderly without detailed descriptions on the living-lab intervention.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: February 21, 2024
• Study Start: October 21, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2030
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

KR (1)