Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04378452 |
| Other study ID # |
COM-COVID |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 31, 2020 |
| Est. completion date |
April 7, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
Fundació Institut Germans Trias i Pujol |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
In March 30, 2020, 78797 confirmed cases of SARS-CoV-2, 6528 deaths and 14709 recovered were
reported in Spain[1]; 16157 cases and 1410 deaths recorded in Catalonia[2]. Case fatality
(8%) is calculated on the registered cases, even if the actual mortality rate is uncertain as
the total number of cases (including those undiagnosed and with mild symptoms) is unknown
[3]. It is already a fact that there is local transmission of SARS-CoV-2 in the community.
Everyone with a compatible respiratory condition is considered likely to be a case of
SARS-CoV-2[4], despite that the etiological diagnosis cannot be made in this context of
health emergency for all cases suspected, because of the lack of kits, personnel and
saturation of the health system.
Other major outbreaks of infectious diseases as Ebola have demonstrated that there is an
important impact on the individuals and the communities. Psychological effects of the disease
itself as well as the traumatic experience on the beloved ones are seen at individual level.
At community level, health services, social system and economic productivity are severely
affected[5].
After 2 months weeks of first case reported in Spain and 2,5 weeks of the quarantine and
self-isolation of the region of Catalonia, the emotional burden of the general community has
increased. In previous studies in other countries in which the SARS-CoV-2 epidemics have
precede ours, a non despicable impact on mental health and emotional burden has been reported
as well as has been demonstrated in mass quarantines which have been implemented in other
epidemics context [6-8]. Moreover, a certain level of anxiety has been reported as necessary
to adopt recommended precautionary measures against infection outbreaks[9], and therefore to
successfully implement public health interventions understanding the attitudes and measuring
psychological impact on people should be mandatory.
On the other hand, in our setting by last report at 30th March 2020, 2600 of the confirmed
cases in Catalonia are healthcare workers, representing the 16%. Besides their obvious
increased risk of being infected, the healthcare workers facing the SARS-CoV-2 epidemics at
frontline (emergency rooms, ICUs and other dept.) are put under a lot of stress and levels of
anxiety. This is worse as the tension to the Health Systems increase, they needing to face
important ethical dilemmas including triage of patients. Moreover, SARS epidemic proved not
only that frontline healthcare workers suffered from chronic stress, but that this lasted at
least for one year after the epidemics wave was over [10].
The aim of the present study is to assess the psychological and socio-economic impact of the
COVID-19 epidemics, and we intend to do this on both the general population and the
healthcare workers.
An anonymous online survey is been shared through social media networks (including telegram,
whatsapp, twitter) in order to get as many responses as possible from individuals of >16
years old. For the healthcare workers subpopulation the questionnaire will be also be
distributed via email, posters, institutional websites and other means deemed appropriate (in
hospital or other healthcare settings). The anonymous online survey will include questions on
sociodemographic data, physical symptoms in the past 14 days, socio-economic impact of the
COVID-19 outbreak, psychological impact of the COVID-19 outbreak and mental health status
(through questions related to depression, anxiety, stress and PSTD, which have been used in
other studies). We will share the survey through social media using the snowball sampling. We
will continuously share the survey in order to collect responses 6 months after the outbreak,
to learn how much the impact of it can last.
The results obtained will allow us to:
- Understand more accurately the impact of the COVID-19 outbreak on general population
wellbeing.
- Measuring the impact on the health-care workers subpopulation which is critical to cope
outbreaks is important to design interventions for stress management and enchance
infection-control measures and patient care.
The COM-COVID project is led by Dr. Cris Vilaplana (Institute for Health Science Research
Germans Trias i Pujol (IGTP)). Dr. Vilaplana's team, mainly dedicated to the study of
tuberculosis (https://unitatdetuberculosiexperimental.wordpress.com/), has been following a
research line for the last 4 years measuring the quality of life of people in the context of
infectious diseases so that they can study people suffering from them in a more holistic and
humanistic way[11,12]. The project is an initiative of the SMA-TB consortium
(https://www.smatb.eu/) (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita
contra la SIDA (https://www.flsida.org/en) is also collaborating in the project.
