Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms

May 2, 2023 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The elderly who's age is more than or equal to 65 years old.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
elders combined with mild mental illness
elders combined with mild mental illness(120 subjects)
elders combined without mild mental illness
elders combined without mild mental illness(120 subjects)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four times a year until the study is completed (up to 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actigraphy-SOL
Time Frame: Four times a year until the study is completed (up to 3 years)
sleep onset latency (SOL)based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Actigraphy-TST
Time Frame: Four times a year until the study is completed (up to 3 years)
Total sleep time (TST, mins) based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Actigraphy-SE
Time Frame: Four times a year until the study is completed (up to 3 years)
Sleep efficiency (SE, %) based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Actigraphy-WASO
Time Frame: Four times a year until the study is completed (up to 3 years)
Wake after sleep onset (WASO) based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Actigraphy-Awake time
Time Frame: Four times a year until the study is completed (up to 3 years)
Awake time based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Actigraphy-TIB
Time Frame: Four times a year until the study is completed (up to 3 years)
Time in bed(TIB) based on actigraphy during the study.
Four times a year until the study is completed (up to 3 years)
Conners' Continuous Performance Test (CPT)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Conners Continuous Performance Test is a computer administered test that is designed to assess problems with attention,impulsivity and vigilance .Many statistics are computed including omission errors , commission errors, hit reaction time, hit reaction time standard error, detectability, response style, perseverations , hit reaction time by block, standard error by block, reaction time by ISI , and standard error by ISI. These statistics are converted to T-scores and can be interpreted in terms of various aspects of attention including inattention, impulsivity, and vigilance.Higher rates of correct detections indicate better attentional capacity.
Four times a year until the study is completed (up to 3 years)
Epworth Sleepoiness Scale (ESS)
Time Frame: Four times a year until the study is completed (up to 3 years)

Epworth Sleepoiness Scale (ESS) assesses the responder's propensity to doze or fall asleep during 8 common daily activities, such as: sitting and reading; sitting inactive in a public place; sitting and talking to someone; sitting quietly after a lunch without alcohol; or in a car, while stopped for a few minutes in traffic.

Score of 0 to 10 indicate normal range of sleepiness in healthy adults.;11 to 14 indicate mild sleepiness;15 to 17 indicate moderate sleepiness;18 to 24 indicate severe sleepiness .
Four times a year until the study is completed (up to 3 years)
Short Form-36 (SF-36)
Time Frame: Four times a year until the study is completed (up to 3 years)
36-Item Short-Form Health Survey (SF-36) includes 11 major questions that evaluate eight components (0-100), with higher scores indicating better outcome.These components include physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health.
Four times a year until the study is completed (up to 3 years)
Geriatric Depression Scale-15(GDS-15)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Geriatric Depression Scale-15 is a screening tool used to identify symptoms of depression in elderly adults.Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.It takes about 5 to 7 minutes to complete.
Four times a year until the study is completed (up to 3 years)
Montreal Cognitive Assessment (MoCA)
Time Frame: Four times a year until the study is completed (up to 3 years)

The Montreal Cognitive Assessment is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. It can help identify those at risk for developing Alzheimer's disease and other forms of dementia. It is also used as a screening tool for conditions like Parkinson's disease, brain tumors, substance abuse, and head trauma.

The MoCA checks different types of cognitive or thinking abilities. These include:orientation,short-term memory/delayed recall,executive function/visuospatial ability,language,abstraction,naming,attention.

Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.1 point is added to the test-taker's score if they have 12 years or less of formal education.

The MoCA contains 30 questions and takes around 10 to 12 minutes to complete.
Four times a year until the study is completed (up to 3 years)
Hospital Anxiety and Depression Scale(HADS)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression.As in the HADS, the response to each item is rated 0-3. Higher scores indicate higher levels of anxiety or depression.
Four times a year until the study is completed (up to 3 years)
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire for assessing the subjective sleep quality, which consists of 19 items and can be calculated and combined into 7 clinically-derived component score (0-3), with higher scores indicating worse sleep quality.
Four times a year until the study is completed (up to 3 years)
Activities of Daily Living (ADL)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-100 indicates "slight" dependency.
Four times a year until the study is completed (up to 3 years)
Lawton Instrumental Activities of Daily Living Scale (IADL)
Time Frame: Four times a year until the study is completed (up to 3 years)

The Instrumental Activities of Daily Living (IADL) Scale is used to assess independent living skills of an individual and measures functional ability as well as declines and improvements over time. The test measures eight realms of function through self report, which attempt to assess everyday functional competence in the elderly. This is done by evaluating a more complex set of behaviours like telephoning, shopping, food preparation, housekeeping, laundering, use of transportation, use of medicine, and financial behaviour. Each domain measured by the scale relies on either cognitive or physical function, though all require some degree of both.

The Lawton IADL scale can be scored in several ways, the most common method is to rate each item either dichotomously (0 = less able, 1 = more able) or trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The higher the score, the greater the person's abilities.
Four times a year until the study is completed (up to 3 years)
Insomnia Severity Index(ISI)
Time Frame: Four times a year until the study is completed (up to 3 years)
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Four times a year until the study is completed (up to 3 years)
Clinical Frailty Scale (CFS)
Time Frame: Four times a year until the study is completed (up to 3 years)
The clinical frailty scale is a 9-point scale that quantifies frailty based on function in individual patients. It is complemented by a visual chart to assist with the classification of frailty. Higher scores indicate increased frailty and associated risks.
Four times a year until the study is completed (up to 3 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability (HRV) device
Time Frame: Four times a year until the study is completed (up to 3 years)
The measurement method is to stick four patches on participants body and measure the heart rhythm state for 10 minutes. An estimate was computed for LF/HF ratio.
Four times a year until the study is completed (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Yu-Shu Huang, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200501B0C603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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