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DepressionNCT05852912

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

An observational study of Depression, run by Chang Gung Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Depression
How many people
240 participants
Where
No sites listed yet
Study dates
1 Jun 2023to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

About this study

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

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.

Read the 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.

Conditions
Depression
Keywords
Elderly, wearable devices
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05852912
Study groupRoleWhat they receive
elders combined with mild mental illnesselders combined with mild mental illness(120 subjects)
elders combined without mild mental illnesselders combined without mild mental illness(120 subjects)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Actigraphy

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

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

Secondary outcomes (17)
  1. Actigraphy-SOL

    sleep onset latency (SOL)based on actigraphy during the study.

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

  2. Actigraphy-TST

    Total sleep time (TST, mins) based on actigraphy during the study.

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

  3. Actigraphy-SE

    Sleep efficiency (SE, %) based on actigraphy during the study.

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

  4. Actigraphy-WASO

    Wake after sleep onset (WASO) based on actigraphy during the study.

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

  5. Actigraphy-Awake time

    Awake time based on actigraphy during the study.

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

  6. Actigraphy-TIB

    Time in bed(TIB) based on actigraphy during the study.

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

  7. Conners' Continuous Performance Test (CPT)

    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.

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

  8. Epworth Sleepoiness Scale (ESS)

    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 .

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

  9. Short Form-36 (SF-36)

    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.

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

  10. Geriatric Depression Scale-15(GDS-15)

    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.

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

  11. Montreal Cognitive Assessment (MoCA)

    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.

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

  12. Hospital Anxiety and Depression Scale(HADS)

    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.

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

  13. Pittsburgh Sleep Quality Index (PSQI)

    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.

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

  14. Activities of Daily Living (ADL)

    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.

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

  15. Lawton Instrumental Activities of Daily Living Scale (IADL)

    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.

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

  16. Insomnia Severity Index(ISI)

    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).

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

  17. Clinical Frailty Scale (CFS)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852912
Sponsor's protocol ID
202200501B0C603
Status last verified
Apr 2023
First submitted
2 May 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blood ML, Sack RL, Percy DC, Pen JC. A comparison of sleep detection by wrist actigraphy, behavioral response, and polysomnography. Sleep. 1997 Jun;20(6):388-95.

    PubMed 9302721
  • Chen NH, Johns MW, Li HY, Chu CC, Liang SC, Shu YH, Chuang ML, Wang PC. Validation of a Chinese version of the Epworth sleepiness scale. Qual Life Res. 2002 Dec;11(8):817-21. doi: 10.1023/a:1020818417949.

    PubMed 12482165
  • Chu KC, Huang YS, Tseng CF, Huang HJ, Wang CH, Tai HY. Reliability and validity of DS-ADHD: A decision support system on attention deficit hyperactivity disorders. Comput Methods Programs Biomed. 2017 Mar;140:241-248. doi: 10.1016/j.cmpb.2016.12.003. Epub 2016 Dec 16.

    PubMed 28254080
  • Edd EM, Flores S. Sleepiness or excessive daytime somnolence. Geriatr Nurs. 2009 Jan-Feb;30(1):53-60. doi: 10.1016/j.gerinurse.2008.11.004.

    PubMed 19215814
  • Hegerl U, Wilk K, Olbrich S, Schoenknecht P, Sander C. Hyperstable regulation of vigilance in patients with major depressive disorder. World J Biol Psychiatry. 2012 Sep;13(6):436-46. doi: 10.3109/15622975.2011.579164. Epub 2011 Jul 4.

    PubMed 21722018
  • Huang YL, Liu RY, Wang QS, Van Someren EJ, Xu H, Zhou JN. Age-associated difference in circadian sleep-wake and rest-activity rhythms. Physiol Behav. 2002 Aug;76(4-5):597-603. doi: 10.1016/s0031-9384(02)00733-3.

    PubMed 12126998
  • Hung CI, Weng LJ, Su YJ, Liu CY. Depression and somatic symptoms scale: a new scale with both depression and somatic symptoms emphasized. Psychiatry Clin Neurosci. 2006 Dec;60(6):700-8. doi: 10.1111/j.1440-1819.2006.01585.x.

    PubMed 17109704
  • Ismail Z, Gatchel J, Bateman DR, Barcelos-Ferreira R, Cantillon M, Jaeger J, Donovan NJ, Mortby ME. Affective and emotional dysregulation as pre-dementia risk markers: exploring the mild behavioral impairment symptoms of depression, anxiety, irritability, and euphoria - CORRIGENDUM. Int Psychogeriatr. 2019 Jan;31(1):157. doi: 10.1017/S1041610218000637. Epub 2018 Nov 21. No abstract available.

    PubMed 30461372
  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PubMed 1798888
  • Kemp AH, Quintana DS, Felmingham KL, Matthews S, Jelinek HF. Depression, comorbid anxiety disorders, and heart rate variability in physically healthy, unmedicated patients: implications for cardiovascular risk. PLoS One. 2012;7(2):e30777. doi: 10.1371/journal.pone.0030777. Epub 2012 Feb 15.

    PubMed 22355326
  • Kok RM, Reynolds CF 3rd. Management of Depression in Older Adults: A Review. JAMA. 2017 May 23;317(20):2114-2122. doi: 10.1001/jama.2017.5706.

    PubMed 28535241
  • Kim J, Nakamura T, Kikuchi H, Sasaki T, Yamamoto Y. Co-variation of depressive mood and locomotor dynamics evaluated by ecological momentary assessment in healthy humans. PLoS One. 2013 Sep 13;8(9):e74979. doi: 10.1371/journal.pone.0074979. eCollection 2013.

    PubMed 24058642
  • Lin C, Chin WC, Huang YS, Chu KC, Paiva T, Chen CC, Guilleminault C. Different circadian rest-active rhythms in Kleine-Levin syndrome: a prospective and case-control study. Sleep. 2021 Sep 13;44(9):zsab096. doi: 10.1093/sleep/zsab096.

    PubMed 33851710
  • Musiek ES, Bhimasani M, Zangrilli MA, Morris JC, Holtzman DM, Ju YS. Circadian Rest-Activity Pattern Changes in Aging and Preclinical Alzheimer Disease. JAMA Neurol. 2018 May 1;75(5):582-590. doi: 10.1001/jamaneurol.2017.4719.

    PubMed 29379963
  • Olbrich S, Sander C, Minkwitz J, Chittka T, Mergl R, Hegerl U, Himmerich H. EEG vigilance regulation patterns and their discriminative power to separate patients with major depression from healthy controls. Neuropsychobiology. 2012 Jun;65(4):188-94. doi: 10.1159/000337000. Epub 2012 Apr 26.

    PubMed 22538271

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by Chang Gung Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu-Shu Huang (+886 3 3281200 ext. 8539, yushuhuang1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Actigraphy (time frame: Four times a year until the study is completed (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05852912, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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