Coronavirus Disease 2019NCT04283838
Humanistic Care in Healthcare Workers in Coronavirus Disease 2019
A study testing Humanistic Care in people with Coronavirus Disease 2019, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Humanistic Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2020to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthcare-personnel who are working for treating COVID-19
- Agree to informed consent
Who cannot join
- disagree to consent
About this study
Official title: The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019
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.
Read the 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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Humanistic Care
- Keywords
- coronavirus disease 2019, Humanistic Care, mental health, post-traumatic stress disorder, Healthcare Workers
- Medical subject headings
- COVID-19, Psychological Well-Being, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humanistic CareBehavioural
Psychological and physical rehabilitation based humanistic care regimen
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Humanistic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rating depression scale
Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator
Measured: 1 month
Secondary outcomes (1)
Incidence of PTSD
the incidence of post-traumatic stress disorder in healthcare workers
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start22 Feb 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion15 May 2020 (estimated)
Why it stopped: We cannot enroll enough participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shouping Gong, MD, PhD, Principal investigator, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283838
- Sponsor's protocol ID
- XJTU2H-WH2
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019
- ClinicalTrials.gov ID
- NCT04283838
- Acronym / sponsor ID
- XJTU2H-WH2
- Conditions
- Coronavirus Disease 2019
- Keywords
- coronavirus disease 2019, Humanistic Care, mental health, post-traumatic stress disorder, Healthcare Workers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We cannot enroll enough participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 22 Feb 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humanistic care | Experimental | Behavioral: Humanistic CarePsychological 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare-personnel who are working for treating COVID-19
- Agree to informed consent
Key exclusion criteria (1 listed)
- disagree to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humanistic CarePsychological and physical rehabilitation based humanistic care regimen | Behavioural | Humanistic care |
Primary outcome
Self-rating depression scale
Time frame: 1 month
Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator
1 secondary outcome
Incidence of PTSD
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shouping Gong, MD, PhD principal investigator
Second Affiliated Hospital of Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A study testing Humanistic Care in people with Coronavirus Disease 2019, run by Second Affiliated Hospital of Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rating depression scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.