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Clinical Trials/NCT05852912
NCT05852912
Not yet recruiting
Not Applicable

Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms: Development of Wearable Devices and Telemedicine as Assessment Tools

Chang Gung Memorial Hospital0 sites240 target enrollmentJune 1, 2023
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Chang Gung Memorial Hospital
Enrollment
240
Primary Endpoint
Actigraphy
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care.

In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.

Detailed Description

Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care. In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed. This study is expected to have the following objectives: 1. To understand the prevalence and current situation of Taiwanese elderly complicated with mild mental illnesses (such as anxiety, insomnia, etc.). 2. Establish a physical and mental assessment tool for the elderly, integrating different scales such as physical health, mental health, and mobility into a complete and convenient information interface for the elderly, caregivers, and medical staff to use to facilitate cross-field connections Communities and hospitals, providing continuum of care. 3. Introduce wearable devices and computerized software to analyze the prognosis of elderly hypertensive patients. Through this project, it is expected to combine the two majors of medical treatment and information technology, and integrate various assessment tools into a convenient information interface, making it easy for the elderly and caregivers to use, and even linking to the medical network to assist in rapid diagnosis, referral and receive treatment. The collected data can be used for big data analysis in the future to provide further national policy reference.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 30, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age is more than or equal to 65 years old
  • Able to provide informed consent to participate in the research.
  • Can understand the instructions, and coduct the questionnaire assessment and physical function measurement.

Exclusion Criteria

  • Those unable to give consent to participate in the research.
  • Those who cannot understand the instructions, difficult to coduct questionnaire assessment and physical function measurement.
  • Severe disease state (respiratory distress requiring intubation or patient with terminal illness) or severe brain injury or severe Dementia.
  • Snstable patients and patients with substance abuse.

Outcomes

Primary Outcomes

Actigraphy

Time Frame: Four times a year until the study is completed (up to 3 years)

Change in sleep latency (mins) based on actigraphy during the study.

Secondary Outcomes

  • Actigraphy-TIB(Four times a year until the study is completed (up to 3 years))
  • Actigraphy-SOL(Four times a year until the study is completed (up to 3 years))
  • Clinical Frailty Scale (CFS)(Four times a year until the study is completed (up to 3 years))
  • Actigraphy-Awake time(Four times a year until the study is completed (up to 3 years))
  • Actigraphy-SE(Four times a year until the study is completed (up to 3 years))
  • Short Form-36 (SF-36)(Four times a year until the study is completed (up to 3 years))
  • Lawton Instrumental Activities of Daily Living Scale (IADL)(Four times a year until the study is completed (up to 3 years))
  • Insomnia Severity Index(ISI)(Four times a year until the study is completed (up to 3 years))
  • Actigraphy-TST(Four times a year until the study is completed (up to 3 years))
  • Geriatric Depression Scale-15(GDS-15)(Four times a year until the study is completed (up to 3 years))
  • Hospital Anxiety and Depression Scale(HADS)(Four times a year until the study is completed (up to 3 years))
  • Pittsburgh Sleep Quality Index (PSQI)(Four times a year until the study is completed (up to 3 years))
  • Actigraphy-WASO(Four times a year until the study is completed (up to 3 years))
  • Activities of Daily Living (ADL)(Four times a year until the study is completed (up to 3 years))
  • Conners' Continuous Performance Test (CPT)(Four times a year until the study is completed (up to 3 years))
  • Epworth Sleepoiness Scale (ESS)(Four times a year until the study is completed (up to 3 years))
  • Montreal Cognitive Assessment (MoCA)(Four times a year until the study is completed (up to 3 years))

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