Humanistic Care in Patients With Coronavirus Disease 2019

March 14, 2020 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

The Therapeutic Efficacy of Psychological and Physical Rehabilitation Based Humanistic Care in Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown their potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019. As the national medical team sent to Wuhan, investigators proposed a Psychological and physical rehabilitation based humanistic care regimen generated from our experience in treating patients with COVID-2019. In addition to routine therapy, investigators will apply this comprehensive humanistic care regimen to the patients according to their condition to see the efficacy to this regimen.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatients with 2019 Novel Coronavirus infection

Exclusion Criteria:

  • Patients can not follow-up;
  • Investigator considering inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Humanistic care
In addition to routine therapy, the combinations of different psychological and physical rehabilitation activities will be applied to the patients.
Behavioral: Psychological and physical rehabilitation based humanistic care
This Psychological and physical rehabilitation based humanistic care regimen is generated from the experience of the National medical team members in Wuhan, from our hospital. In addition to the routine therapy, we will apply this comprehensive humanistic care regimen to the patients according to their condition. The patients will be stratified by the severity and receive different combinations of Psychological and physical rehabilitation activities.
No Intervention: Non-humanistic care
Patients only receive routine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Time
Time Frame: 1 month
Time for recovery from admission to discharged
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rating depression scale
Time Frame: 1 month
Self-rating depression scale will be finished from patients by a scale table designed by investigator
1 month
Survival rate
Time Frame: 1 month
Survival rate of the patient after treatment
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Shouping Gong, MD, PhD, Second Affiliated Hospital of Xi'an JiaoTong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 22, 2020

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

May 15, 2020

Study Registration Dates

First Submitted

February 22, 2020

First Submitted That Met QC Criteria

February 22, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU2H-WH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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