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

NCT ID: NCT05852912

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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elders combined with mild mental illness

elders combined with mild mental illness(120 subjects)

No interventions assigned to this group

elders combined without mild mental illness

elders combined without mild mental illness(120 subjects)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Shu Huang

Role: STUDY_DIRECTOR

Principal Investigator

Central Contacts

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Yu-Shu Huang

Role: CONTACT

+886 3 3281200 ext. 8539

References

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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.

Reference Type RESULT
PMID: 9302721 (View on PubMed)

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.

Reference Type RESULT
PMID: 12482165 (View on PubMed)

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.

Reference Type RESULT
PMID: 28254080 (View on PubMed)

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.

Reference Type RESULT
PMID: 19215814 (View on PubMed)

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.

Reference Type RESULT
PMID: 21722018 (View on PubMed)

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.

Reference Type RESULT
PMID: 12126998 (View on PubMed)

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.

Reference Type RESULT
PMID: 17109704 (View on PubMed)

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.

Reference Type RESULT
PMID: 30461372 (View on PubMed)

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.

Reference Type RESULT
PMID: 1798888 (View on PubMed)

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.

Reference Type RESULT
PMID: 22355326 (View on PubMed)

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.

Reference Type RESULT
PMID: 28535241 (View on PubMed)

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.

Reference Type RESULT
PMID: 24058642 (View on PubMed)

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.

Reference Type RESULT
PMID: 33851710 (View on PubMed)

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.

Reference Type RESULT
PMID: 29379963 (View on PubMed)

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.

Reference Type RESULT
PMID: 22538271 (View on PubMed)

Olbrich S, van Dinteren R, Arns M. Personalized Medicine: Review and Perspectives of Promising Baseline EEG Biomarkers in Major Depressive Disorder and Attention Deficit Hyperactivity Disorder. Neuropsychobiology. 2015;72(3-4):229-40. doi: 10.1159/000437435. Epub 2016 Feb 23.

Reference Type RESULT
PMID: 26901357 (View on PubMed)

Ong AD, Uchino BN, Wethington E. Loneliness and Health in Older Adults: A Mini-Review and Synthesis. Gerontology. 2016;62(4):443-9. doi: 10.1159/000441651. Epub 2015 Nov 6.

Reference Type RESULT
PMID: 26539997 (View on PubMed)

Pan W, Song Y, Kwak S, Yoshida S, Yamamoto Y. Quantitative evaluation of the use of actigraphy for neurological and psychiatric disorders. Behav Neurol. 2014;2014:897282. doi: 10.1155/2014/897282. Epub 2014 Aug 19.

Reference Type RESULT
PMID: 25214709 (View on PubMed)

Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

Reference Type RESULT
PMID: 8576833 (View on PubMed)

Sgoifo A, Carnevali L, Alfonso Mde L, Amore M. Autonomic dysfunction and heart rate variability in depression. Stress. 2015;18(3):343-52. doi: 10.3109/10253890.2015.1045868. Epub 2015 May 25.

Reference Type RESULT
PMID: 26004818 (View on PubMed)

Shaked D, Faulkner LMD, Tolle K, Wendell CR, Waldstein SR, Spencer RJ. Reliability and validity of the Conners' Continuous Performance Test. Appl Neuropsychol Adult. 2020 Sep-Oct;27(5):478-487. doi: 10.1080/23279095.2019.1570199. Epub 2019 Feb 22.

Reference Type RESULT
PMID: 30793982 (View on PubMed)

Stapelberg NJ, Hamilton-Craig I, Neumann DL, Shum DH, McConnell H. Mind and heart: heart rate variability in major depressive disorder and coronary heart disease - a review and recommendations. Aust N Z J Psychiatry. 2012 Oct;46(10):946-57. doi: 10.1177/0004867412444624. Epub 2012 Apr 23.

Reference Type RESULT
PMID: 22528974 (View on PubMed)

van Someren EJ, Hagebeuk EE, Lijzenga C, Scheltens P, de Rooij SE, Jonker C, Pot AM, Mirmiran M, Swaab DF. Circadian rest-activity rhythm disturbances in Alzheimer's disease. Biol Psychiatry. 1996 Aug 15;40(4):259-70. doi: 10.1016/0006-3223(95)00370-3.

Reference Type RESULT
PMID: 8871772 (View on PubMed)

Wahl D, Solon-Biet SM, Cogger VC, Fontana L, Simpson SJ, Le Couteur DG, Ribeiro RV. Aging, lifestyle and dementia. Neurobiol Dis. 2019 Oct;130:104481. doi: 10.1016/j.nbd.2019.104481. Epub 2019 May 25.

Reference Type RESULT
PMID: 31136814 (View on PubMed)

Wong NM, Liu HL, Lin C, Huang CM, Wai YY, Lee SH, Lee TM. Loneliness in late-life depression: structural and functional connectivity during affective processing. Psychol Med. 2016 Sep;46(12):2485-99. doi: 10.1017/S0033291716001033. Epub 2016 Jun 22.

Reference Type RESULT
PMID: 27328861 (View on PubMed)

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

Reference Type RESULT
PMID: 6880820 (View on PubMed)

Other Identifiers

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202200501B0C603

Identifier Type: -

Identifier Source: org_study_id

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