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

NCT04376775 | Completed

• 1 other identifier: CHUBX 2020/19
• Study Type: observational
• Target: 3,602
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplantation

Keywords

Waiting list; Transplantation; Covid-19

Outcome Measures

Primary Outcomes (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.

  In a maximum of 6 months after inclusion

Secondary Outcomes (1)

• Clinical impact of COVID-19

  In a maximum of 6 months after inclusion

Study Arms (1)

Transplant patient

This 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.

Other: Transplant patient

Interventions

Transplant patient OTHER

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.

Transplant patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Société Francophone de Transplantation: collaborator

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: May 11, 2020
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

FR (1)