Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04376775 |
| Other study ID # |
CHUBX 2020/19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2020 |
| Est. completion date |
May 11, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
University Hospital, Bordeaux |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To provide optimal care to patients and to maintain long-term institutional viability,
Transplant Centres (TC) must have an awareness of their patients' health status, their health
care needs and priorities, as well as their access to information and health care. For
example, it is critical that TCs understand whether their patients are medically suitable for
transplant, whether transplantation remains a priority for their patients, how best to
communicate with their patients, and whether their patients have sufficient access to
medications and health care to undergo transplant safely. The COVID-19 pandemic has had a
tremendous impact on people and institutions around the country in a short period of time. At
this time, little is known regarding its impact on the transplant community specifically. For
example, it has been reported that around 8 million French applied for partial unemployment
benefit over the past month, but it is not known if this has affected transplant patients. It
has been reported that people with significant chronic medical conditions and those with
compromised immune systems may be at increased risk of dying from the COVID-19, but it is not
known if this has affected patients' interest in receiving transplants at this time. The
"Société Francophone de Transplantation (SFT)" published recommendations at the beginning of
the pandemic in order to limit the rate of infection in these high-risk population. The
purpose of this study is to better understand the impact of COVID-19 on patients on the
waiting list and transplant patients. Further, a better understand on how patients have
received information about this pandemic and how best to communicate with them.
Description:
Transplant Centres (TCs) serve a unique patient population, those with end-organ disease who
are either waiting for, or who have received, a solid-organ transplant. For transplant
candidates, TCs help weigh the threat of their current condition against the intended
benefits and associated risks of transplantation, which include major-surgery and chronic
immune suppression (IS). For transplant recipients, TCs help manage the life-long risks
associated with IS, including infection and malignancy, and facilitate access to appropriate
health care over time.
To provide optimal care to patients and to maintain long-term institutional viability, TCs
must have an awareness of their patients' health status, their health care needs and
priorities, as well as their access to information and health care. For example, it is
critical that TCs understand whether their patients are medically suitable for transplant,
whether transplantation remains a priority for their patients, how best to communicate with
their patients, and whether their patients have sufficient access to medications and health
care to undergo transplant safely.
The COVID-19 pandemic has had a tremendous impact on people and institutions around the
country in a short period of time. At this time, little is known regarding its impact on the
transplant community specifically. For example, it has been reported that around 8 million
French applied for partial unemployment benefit over the past month, but it is not known if
this has affected transplant patients. It has been reported that people with significant
chronic medical conditions and those with compromised immune systems may be at increased risk
of dying from the COVID-19, but it is not known if this has affected patients' interest in
receiving transplants at this time. The "Société Francophone de Transplantation (SFT)"
published recommendations at the beginning of the pandemic in order to limit the rate of
infection in these high-risk population. Briefly, these recommendations encompassed the
following points: Not stopping immunosuppression, strict application of the social
distancing, recommendation to stay and work at home, recommendation to limit the visits at
the hospital. However, it is still unclear whether these recommendations were followed by the
transplant recipients, and if this exceptional situation has affected their access to health
care or needed medications.
The purpose of our study is to better understand the impact of COVID-19 on patients on the
waiting list and transplant patients. Further, a better understand on how patients are
receiving information about this pandemic and how best to communicate with them. The
hypothesis is that peri-transplant patient groups may appropriately perceive themselves to be
at high risk of infection and poor outcomes, and that this may influence their decisions
around seeking medical care and willingness to undergo organ transplantation. Additionally,
the investigator anticipate a wide range of needs and risks among patients, including their
ability to isolate from potential infection, ability to access medications and medical care,
and their ability to access information regarding COVID-19. Ultimately, the investigator plan
to use the information collected from patients to improve patient education regarding
COVID-19 and to inform centres' response to future epidemics and/or natural disasters that
disrupt patient care. Until now, no systematic description of transplant patients' needs,
priorities, behavior's, attitudes, or education has been done during this pandemic.
