NCT04283838

Brief Summary

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

March 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 22, 2020

Last Update Submit

March 14, 2020

Conditions

Coronavirus Disease 2019

Keywords

coronavirus disease 2019Humanistic Caremental healthpost-traumatic stress disorderHealthcare Workers

Outcome Measures

Primary Outcomes (1)

  • Self-rating depression scale

    Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator

    1 month

Secondary Outcomes (1)

  • Incidence of PTSD

    1 month

Study Arms (1)

Humanistic care

EXPERIMENTAL

Psychological and physical rehabilitation based humanistic care regimen was used to prevent depression and PTSD in healthcare workers who participated in the treatment of COVID-19.

Behavioral: Humanistic Care

Interventions

Humanistic CareBEHAVIORAL

Psychological and physical rehabilitation based humanistic care regimen

Humanistic care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare-personnel who are working for treating COVID-19
  • Agree to informed consent

You may not qualify if:

  • disagree to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Psychological Well-BeingStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Shouping Gong, MD, PhD

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2020

First Posted

February 25, 2020

Study Start

February 22, 2020

Primary Completion

April 30, 2020

Study Completion

May 15, 2020

Last Updated

March 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share