Back to resultsHumanistic Care in Patients With Coronavirus Disease 2019
Primary Purpose
Coronavirus Disease 2019
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychological and physical rehabilitation based humanistic care
Sponsored by
About this trial
This is an interventional supportive care trial for Coronavirus Disease 2019 focused on measuring coronavirus disease 2019, physical rehabilitation, psychological rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Inpatients with 2019 Novel Coronavirus infection
Exclusion Criteria:
- Patients can not follow-up;
- Investigator considering inappropriate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Humanistic care
Non-humanistic care
Arm Description
In addition to routine therapy, the combinations of different psychological and physical rehabilitation activities will be applied to the patients.
Patients only receive routine therapy.
Outcomes
Primary Outcome Measures
Recovery Time
Time for recovery from admission to discharged
Secondary Outcome Measures
Self-rating depression scale
Self-rating depression scale will be finished from patients by a scale table designed by investigator
Survival rate
Survival rate of the patient after treatment
Full Information
NCT ID
NCT04283825
First Posted
February 22, 2020
Last Updated
March 14, 2020
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04283825
Brief Title
Humanistic Care in Patients With Coronavirus Disease 2019
Official Title
The Therapeutic Efficacy of Psychological and Physical Rehabilitation Based Humanistic Care in Patients With Coronavirus Disease 2019
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
We cannot enroll enough participants.
Study Start Date
February 22, 2020 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019
Keywords
coronavirus disease 2019, physical rehabilitation, psychological rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Humanistic care
Arm Type
Experimental
Arm Description
In addition to routine therapy, the combinations of different psychological and physical rehabilitation activities will be applied to the patients.
Arm Title
Non-humanistic care
Arm Type
No Intervention
Arm Description
Patients only receive routine therapy.
Intervention Type
Behavioral
Intervention Name(s)
Psychological and physical rehabilitation based humanistic care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery Time
Description
Time for recovery from admission to discharged
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Self-rating depression scale
Description
Self-rating depression scale will be finished from patients by a scale table designed by investigator
Time Frame
1 month
Title
Survival rate
Description
Survival rate of the patient after treatment
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients with 2019 Novel Coronavirus infection
Exclusion Criteria:
Patients can not follow-up;
Investigator considering inappropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shouping Gong, MD, PhD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Humanistic Care in Patients With Coronavirus Disease 2019
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