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TransplantationCOWAITNCT04376775

Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation

An observational study of Transplantation, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transplantation
What is being tested?
Transplant patient
How many people
3,602 participants
Where
1 siteFrance
Study dates
11 May 2020to 11 May 2020
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients registered on the French waiting list for a transplant and patients transplanted with a functional graft.

Who may be able to join

  • Over 18 years of age
  • Patients currently (at the time of survey) on a French transplant waiting list.
  • Patients transplanted with a functional graft.

Who cannot join

  • Under 18 years of age,
  • Patients under protective measures or deprived of their liberty:
  • pregnant or breastfeeding woman, under guardianship, under curatorship, safeguard of justice, incarcerated.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Pellegrin

    Bordeaux, 33000

Other trials in France

About this study

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.

Read the detailed 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.

Conditions
Transplantation
Being tested
Transplant patient
Keywords
Waiting list, Transplantation, Covid-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transplant patientOther

    Surveys will be distributed via an email sent by transplant centres or patient's associations. A link to a secure survey platform will be given. A questionnaire will completed by patients. Patients, who agreed to fill the survey, will be offered the possibility to be contacted for a second survey over a 6 months period.

Study groups in NCT04376775
Study groupRoleWhat they receive
Transplant patientThis study will involve all the transplant centres in France. The investigator will use patient-completed surveys for all participants. Wait Listed Transplant Candidates and Transplant Recipients (liver, kidney, pancreas, heart, lung) will be contacted by the all French transplant centres and patient's associations.
Receives: Other: Transplant patient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance precautions with COVID-19

    The compliance will be assessed by the questionnaire created for the study. The questionnaire has 38 questions with multiple choice for each question.

    Measured: In a maximum of 6 months after inclusion

Secondary outcomes (1)
  1. Clinical impact of COVID-19

    The clinical impact will be assessed by the questionnaire created for the study. The questionnaire has 38 questions with multiple choice for each question.

    Measured: In a maximum of 6 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2020
  2. Study start11 May 2020
  3. Primary completion11 May 2020
  4. Study completion11 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04376775
Sponsor's protocol ID
CHUBX 2020/19
Acronym
COWAIT
Status last verified
Jun 2021
First submitted
4 May 2020
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Transplantation, run by University Hospital, Bordeaux at 1 site in France.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Compliance precautions with COVID-19 (time frame: In a maximum of 6 months after inclusion). 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 7 Jun 2021.

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