Humanistic Care in Healthcare Workers in Coronavirus Dise... | NCT04283838

Studies
Humanistic Care in Healthcare Workers in Coronavirus Disease 2019

NCT04283838

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Status

Withdrawn

Last Update Posted

Mar 17, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Coronavirus Disease 2019

Interventions

Humanistic Care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We cannot enroll enough participants.

Expanded Access Info

Start Date

Feb 22, 2020Estimated

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

May 15, 2020Estimated

First Submitted Date

Feb 22, 2020

First Submission Date that Met QC Criteria

Feb 22, 2020

First Posted Date

Feb 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2020

Last Update Posted Date

Mar 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. As the national medical team sent to Wuhan, the investigators proposed a psychological and physical rehabilitation based humanistic care regimen generated from experience in treating patients with COVID-19. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. The investigators want to apply this regimen to the healthcare workers who participated in the treatment of COVID-19, to evaluate the positive effect of humanistic care on preventing depression and post-traumatic stress disorder.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Humanistic Care	Behavioral	Psychological and physical rehabilitation based humanistic care regimen	Humanistic care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of PTSD	the incidence of post-traumatic stress disorder in healthcare workers	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

disagree to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shouping Gong, MD, PhD	Second Affiliated Hospital of Xi'an Jiaotong University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D000092862	Psychological Well-Being
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided