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Assessment of the Psycho-social Impact of COVID-19 Outbreak (COM-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378452
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Anaxomics
Fundació Lluita contra la Sida (FLS)
Information provided by (Responsible Party):
Fundació Institut Germans Trias i Pujol

Brief Summary:

It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, these front-line staff are exposed to high levels of stress and anxiety. This gets worse as the pressure on the health system increases, forcing them to deal with significant ethical issues.

To respond to all these issues, the research group led by Dr. Cris Vilaplana at the Germans Trias i Pujol Research Institute (IGTP), have launched a questionnaire to ask the public, including health professionals, how are they being affected by the pandemic, not only in relation to their health but in terms of their emotional wellbeing and their family finances. The project is an initiative of the SMA-TB consortium (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA is also collaborating in the project. The survey is based on questions related to depression, anxiety, stress, and post-traumatic stress disorder, which have already been used in other epidemic outbreaks and in disaster situations, but it also includes questions adapted to the current situation.

The survey (now available in 4 languages) has been designed to be shared using a snowball strategy, making possible for everybody to participate and collaborate. The results obtained will initially help us to better understand the impact of the outbreak of COVID-19 on the general wellbeing of the population and health workers so that we can go on to develop strategies in coordination those in charge of administrations in order to adapt policies to people's real needs. The results of the study will be published in a scientific article and will be publicly available.


Condition or disease Intervention/treatment
SARS-CoV 2 COVID-19 Quality of Life Mental Health Wellness 1 Social Distance SARS (Disease) Psychological Behavioral: COM-COVID anonimous survey

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 65000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Assessment of the Psycho-social Impact of COVID-19 Outbreak (COM-COVID)
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
COM-COVID cohort
Individuals of >16 years old evaluated during the COVID-19 outbreak by an anonymous survey and willing to respond. Expected timeframe for the collection of completed surveys: March 31th, 2020-September 30th, 2020]
Behavioral: COM-COVID anonimous survey
Anonimous e-survey administered to the general population by sharing it through social and mass media, including questions on sociodemographic data, physical symptoms in the past 14 days compatible with SARS-CoV-2 infection, socio-economic impact of the COVID-19 outbreak and psychological impact of the COVID-19 outbreak and mental health status.




Primary Outcome Measures :
  1. Psychological impact of the outbreak, total score [ Time Frame: Through study completion, an average of 1 year. ]
    Psychological impact of the outbreak, total score will be measured by the sum of the depression questions score, the anxiety questions score, the stress questions score and the PSTD questions score. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

  2. Psychological impact of the outbreak: depression questions score [ Time Frame: Through study completion, an average of 1 year. ]
    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

  3. Psychological impact of the outbreak: anxiety questions score [ Time Frame: Through study completion, an average of 1 year. ]
    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

  4. Psychological impact of the outbreak: stress questions score [ Time Frame: Through study completion, an average of 1 year. ]
    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

  5. Psychological impact of the outbreak: PSTD questions score [ Time Frame: Through study completion, an average of 1 year. ]
    The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 0-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)

  6. Descriptive statistics for the non-psychological questions [ Time Frame: Through study completion, an average of 1 year. ]
    Percentages of response will be calculated according to the number of respondents per each response out of the total number of responses of each question. All results will be given according to the respondents being part of the whole cohort of respondents, according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported per gender, age, country and postal code.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The respondents to the survey can choose one of the following responses to the question: "Which gender do you identify with?": male, female, non binary, I prefer not to say
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All people >16 years old willing to participate in the COM-COVID survey study during the COVID-19 outbreak (period March 2020-September 2020).
Criteria

Inclusion Criteria:

  • age = or >16 years old
  • accepting to participate in the project and filling in the survey questionnaire

Exclusion Criteria:

  • age <16 years old
  • non accepting to participate in the project and filling in the survey questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378452


Contacts
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Contact: Cris Vilaplana, MD, PhD +34930330527 cvilaplana@gmail.com, cvilaplana@igtp.cat
Contact: Lilibeth Arias, PhD larias@igtp.cat

Locations
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Spain
Fundació Institut Germans Trias i Pujol Recruiting
Badalona, Catalonia, Spain, 08916
Contact: Cris Vilaplana, MD, PhD    +34930330527    cvilaplana@gmail.com, cvilaplana@igtp.cat   
Contact: Lilibeth Arias, PhD       larias@igtp.cat, secretary.ute@gmail.com   
Sub-Investigator: Lilibeth Arias, PhD         
Sub-Investigator: Pere-Joan Cardona, MD, PhD         
Sub-Investigator: Maria Rosa Sarrias, PhD         
Sub-Investigator: Pau Benito         
Sub-Investigator: Carol Armengol, PhD         
Fundació Lluita contra la Sida (FLS, Fight AIDS Foundation) Recruiting
Badalona, Catalonia, Spain, 08916
Contact: José A Muñoz-Moreno, PhD    +34934978887    jmunoz@flsida.org   
Contact       info@flsida.org   
Anaxomics biotech Recruiting
Barcelona, Spain, 08007
Contact: Judith Farrés, PhD    +34 934 516 717    SMA-TB@anaxomics.com   
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Anaxomics
Fundació Lluita contra la Sida (FLS)
Investigators
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Principal Investigator: Cris Vilaplana, MD, PhD Fundació Institut Germans Trias i Pujol
Additional Information:
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Responsible Party: Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT04378452    
Other Study ID Numbers: COM-COVID
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results and database could be available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut Germans Trias i Pujol:
SARS-CoV-2
COVID-19
psycho-social impact
mental health
infectious diseases