Clinical trial NCT05852912: Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Depression
Keywords: Elderly
wearable devices
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The elderly who's age is more than or equal to 65 years old.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Actigraphy
timeFrame: Four times a year until the study is completed (up to 3 years)
Secondary outcomes:
measure: Actigraphy-SOL
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Actigraphy-TST
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Actigraphy-SE
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Actigraphy-WASO
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Actigraphy-Awake time
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Actigraphy-TIB
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Conners' Continuous Performance Test (CPT)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Epworth Sleepoiness Scale (ESS)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Short Form-36 (SF-36)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Geriatric Depression Scale-15(GDS-15)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Activities of Daily Living (ADL)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Insomnia Severity Index(ISI)
timeFrame: Four times a year until the study is completed (up to 3 years)
measure: Clinical Frailty Scale (CFS)
timeFrame: Four times a year until the study is completed (up to 3 years)
Other outcomes:
measure: Heart rate variability (HRV) device
timeFrame: Four times a year until the study is completed (up to 3 years)
Locations:
Study officials:
affiliation: Principal Investigator
name: Yu-Shu Huang
role: STUDY_DIRECTOR
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