- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04365348
The Psychological Impact of COVID-19 Outbreak on COVID-19 Survivors and Their Families
27. november 2021 opdateret af: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
Exploring the Psychological Impact of the COVID-19 Outbreak on COVID-19 Survivors and Their Families
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level.
Currently, there is little information on the mental health implications of exposure amongst COVID-19 survivors and their family members.
Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19.
This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Since the 2019 coronavirus disease (COVID-19) was first reported, it has been rapidly transmitted and has aroused enormous global attention.
Infected patients may develop severe and even fatal respiratory symptoms such as acute respiratory distress syndrome (ARDS) and acute respiratory failure, ending up in intensive care.
Patients with COVID-19 diagnoses are treated under isolation in hospitals and with high-stress level.
The stress and psychological impact on patients were also correlated significantly with several adverse psychological effects, such as fatigue, fear of social contact, poor sleep, loneliness, and depressed mood.
The psychological impact of COVID-19 may also evolve and last for a prolonged period after discharge from the hospital.
However, there is currently little information on the mental health implications of exposure amongst COVID-19 survivors and their family members.
Research exploring the psychological impact amongst survivors of exposure to COVID-19 is desperately needed to understand the effects, mental health toll, and support required in survivors of COVID-19.
This study aims to assess the psychological impact of the COVID-19 outbreak on COVID-19 survivors and their family members.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Agnes YK Lai, PhD
- Telefonnummer: 39176328
- E-mail: agneslai@hku.hk
Undersøgelse Kontakt Backup
- Navn: Mary SM Ip, MD
- Telefonnummer: 22554455
- E-mail: msmip@hku.hk
Studiesteder
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-
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Hong Kong, Hong Kong, 852
- Rekruttering
- Agnes
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Ledende efterforsker:
- Agnes YK Lai, PhD
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Kontakt:
- Agnes YK Lai
- E-mail: agneslai@hku.hk
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
COVID-19 Survivors: 300; Family members of COVID-19 Survivors:300
Beskrivelse
Inclusion Criteria:
- COVID-19 survivors (i.e., diagnosed with COVID-19 and discharged from the hospital) and/or a family member of a COVID-19 survivor;
- Aged 18 years or above;
- No medical diagnosis of psychiatric illness
Exclusion Criteria:
• Refusal to give consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Stress level
Tidsramme: 1 month
|
measured by the 10-item Perceived Stress Scale
|
1 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Stress level
Tidsramme: 3 months
|
measured by the 10-item Perceived Stress Scale
|
3 months
|
|
Negative emotion
Tidsramme: 3 months
|
measured by the 13-item Hospital Anxiety and Depression Scale
|
3 months
|
|
Psychological response to trauma
Tidsramme: 1 month and 3 months
|
measured by the 22-item Impact of Event Scale -Revised
|
1 month and 3 months
|
|
Severity of insomnia symptoms and the associated daytime impairment
Tidsramme: 1 month and 3 months
|
measured by the 7-item Insomnia Severity Index
|
1 month and 3 months
|
|
Resilience
Tidsramme: 1 month and 3 months
|
measured by the 2-item Connor-Davidson Resilience Scale
|
1 month and 3 months
|
|
Quality of family functioning
Tidsramme: 1 month and 3 months
|
measured by 3-item Family Functioning Subscale
|
1 month and 3 months
|
|
Social support
Tidsramme: 1 month and 3 months
|
measured by 6-item social support questionnaire
|
1 month and 3 months
|
|
Psychological effects
Tidsramme: 1 month and 3 months
|
measured by 10-item outcome-based questionnaire
|
1 month and 3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, Chan MT, Wong TK, Choy KM, Chu CM, Lee PW, Tsang KW. Stress and psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004 Jun;49(6):385-90. doi: 10.1177/070674370404900607.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. maj 2020
Primær færdiggørelse (Forventet)
31. maj 2023
Studieafslutning (Forventet)
30. juni 2023
Datoer for studieregistrering
Først indsendt
25. april 2020
Først indsendt, der opfyldte QC-kriterier
25. april 2020
Først opslået (Faktiske)
28. april 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UW20-300
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
It has not been mentioned in the participants' consent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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