Solid Organ TransplantationTransplantIANCT05932030
Assessment of Knowledge and Perceptions of Artificial Intelligence in Solid Organ Transplantation
A study testing Survey in people with Solid Organ Transplantation and Artificial Intelligence, run by University Hospital, Grenoble.
Trial summary
The increasing abundance of clinical, genetic, radiological, and metabolic data in transplantation has led to a growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Organ Transplantation, Artificial Intelligence
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,750 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Dec 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age greater than or equal to 18 years
- solid organ transplant patients or health professionals working in transplantation
- no opposition to the study
Who cannot join
- subject under guardianship or deprived of liberty
- hematopoietic stem cell transplantation
Trial locations and contacts
No sites are listed yet.
About this study
The increasing abundance of clinical, genetic, radiological, and metabolic data in transplantation has led to a growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.
However, the majority of these applications exist only in the preclinical state and the field of artificial intelligence remains unknown to the general public. In view of the potential applications of AI and the growing research interest in this topic, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.
Read more
Primary Objective: To assess the knowledge and perceptions of solid organ transplant patients and healthcare professionals working in the field of solid organ transplantation
Primary endpoint:
- Analysis of verbatim and closed-ended questionnaire data
- Comparison of the averages obtained by the subgroups of patients and health professionals and analysis of the verbatim by grouping them by themes
Read the detailed description
Solid organ transplantation is the treatment of last resort for end-stage organ disease. In France, 51860 patients receive transplants, and the number of candidates awaiting transplantation has doubled in 10 years. At the same time as considerable progress has been made in recent decades, new challenges have emerged. The growing disparity between demand and supply of organs calls for optimal selection and matching of patients and donors. Improving long-term graft and patient survival requires data-driven diagnosis and management of post-transplant complications. The increasing abundance of clinical, genetic, radiological and metabolic data in transplantation has led to growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.
However, the majority of these applications are still in the pre-clinical stage, and the field of artificial intelligence remains largely unknown to the general public. In view of the potential applications of AI and the growing research interest in the subject, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.
This is a prospective, observational, multicenter study. The questionnaire will be submitted face-to-face to healthcare professionals working in solid organ transplantation and solid organ transplant patients at Grenoble Alpes University Hospital. It will be put online on the LimeSurvey platform and offered to healthcare professionals at France's various transplant centers via the federations of each organ specialty, as well as to all organ transplant patients in France via patient associations.
The data included will be collected from paper questionnaires and online on the LimeSurvey platform. They will be stored on a secure server at the TIMC research laboratory department. Data will be anonymized for inclusion in the database. An identifier will be assigned to each volunteer at the time of inclusion.
Categorical data will be reported as frequency, percentage, and continuous data as mean and standard deviation or median and interquartile range if they do not follow a normal distribution. The normality of quantitative variables will be tested by graphical verification.
Continuous variables will be compared using a Student's t test if the conditions of application are valid (or Mann-Whitney if applicable). Categorical variables will be compared using a Chi2 test (or Fisher's test if validity conditions are not met).
We consider p values <0.05 to be significant. Statistical analysis will be carried out using RStudio software (version 4.2.1).
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Submission of a survey to solid organ transplant patients and health professionals working in transplantation to assess their knowledge and perception of the use of artificial intelligence in transplantation
| Study group | Role | What they receive |
|---|---|---|
| patients and health professionals | Other | The intervention is a survey administered to patients and health professional. The two questionnaires are identical, with only the socio-demographic section differing. The questionnaire is composed of closed questions, scale scores and short-answer questions. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and perceptions evaluation of solid organ transplant patients and healthcare professionals working with solid organ transplantation
Analysis of the verbatim by theme and comparison of the averages of closed questions or scale questions of the questionnaire obtained by the subgroups of patients and health professionals. For scale question studying the knowledge of AI the score goes from 0 to 10 with 0 for no knowledge and 10 for perfect knowledge. A verbatim is the complete reproduction of the words spoken by the interviewee. Verbatim will be grouped by response group and compared.
Measured: 15 minutes
Secondary outcomes (6)
Level of knowledge comparison between different healthcare professionals on artificial intelligence
Comparison of the averages obtained by the different types of health professionals. The average is calculated from the results obtained for the closed questions and the knowledge level score (ranging from 0 to 10, 0 for no knowledge and 10 for perfect knowledge) in the questionnaire.
Measured: 15 minutes
Perceptions comparison between different healthcare professionals on artificial intelligence
Analysis of the verbatim by grouping them by theme. A verbatim is the complete reproduction of the words spoken by the interviewee. Verbatim will be grouped by response group and compared.
Measured: 15 minutes
Comparison of level of artificial intelligence knowledge of patients based on the transplanted organ
Comparison of the averages obtained by patients by transplanted organ. The average is calculated from the results obtained for the closed questions and the knowledge level score (ranging from 0 to 10, 0 for no knowledge and 10 for perfect knowledge) in the questionnaire.
Measured: 15 minutes
Comparison of the perception on artificial intelligence of patients according to the transplanted organ
Analysis of the verbatim by grouping them by theme. A verbatim is the complete reproduction of the words spoken by the interviewee. Verbatim will be grouped by response group and compared.
Measured: 15 minutes
Comparison of the average level of knowledge about artificial intelligence of healthcare professionals and patients.
Comparison of overall averages between patients and health professionals. The average is calculated from the results obtained for the closed questions and the knowledge level score (ranging from 0 to 10, 0 for no knowledge and 10 for perfect knowledge) in the questionnaire.
Measured: 15 minutes
Comparison of the levels of perception of artificial intelligence among healthcare professionals and patients
Analysis of the verbatim by grouping them by theme. A verbatim is the complete reproduction of the words spoken by the interviewee. Verbatim will be grouped by response group and compared.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierrick Bedouch, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932030
- Sponsor's protocol ID
- 2023-A00950-45
- Acronym
- TransplantIA
- Status last verified
- Jun 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knowledge and Perceptions of Artificial Intelligence in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT05932030
- Acronym / sponsor ID
- TransplantIA / 2023-A00950-45
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,750 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increasing abundance of clinical, genetic, radiological, and metabolic data in transplantation has led to a growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.
However, the majority of these applications exist only in the preclinical state and the field of artificial intelligence remains unknown to the general public. In view of the potential applications of AI and the growing research interest in this topic, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.
Primary Objective: To assess the knowledge and perceptions of solid organ transplant patients and healthcare professionals working in the field of solid organ transplantation
Primary endpoint:
- Analysis of verbatim and closed-ended questionnaire data
- Comparison of the averages obtained by the subgroups of patients and health professionals and analysis of the verbatim by grouping them by themes
Detailed description
Solid organ transplantation is the treatment of last resort for end-stage organ disease. In France, 51860 patients receive transplants, and the number of candidates awaiting transplantation has doubled in 10 years. At the same time as considerable progress has been made in recent decades, new challenges have emerged. The growing disparity between demand and supply of organs calls for optimal selection and matching of patients and donors. Improving long-term graft and patient survival requires data-driven diagnosis and management of post-transplant complications. The increasing abundance of clinical, genetic, radiological and metabolic data in transplantation has led to growing interest in applying artificial intelligence (AI) tools to optimize immunosuppression and overall patient management.
However, the majority of these applications are still in the pre-clinical stage, and the field of artificial intelligence remains largely unknown to the general public. In view of the potential applications of AI and the growing research interest in the subject, it is essential to assess the knowledge and perceptions of those directly involved in solid organ transplantation.
This is a prospective, observational, multicenter study. The questionnaire will be submitted face-to-face to healthcare professionals working in solid organ transplantation and solid organ transplant patients at Grenoble Alpes University Hospital. It will be put online on the LimeSurvey platform and offered to healthcare professionals at France's various transplant centers via the federations of each organ specialty, as well as to all organ transplant patients in France via patient associations.
The data included will be collected from paper questionnaires and online on the LimeSurvey platform. They will be stored on a secure server at the TIMC research laboratory department. Data will be anonymized for inclusion in the database. An identifier will be assigned to each volunteer at the time of inclusion.
Categorical data will be reported as frequency, percentage, and continuous data as mean and standard deviation or median and interquartile range if they do not follow a normal distribution. The normality of quantitative variables will be tested by graphical verification.
Continuous variables will be compared using a Student's t test if the conditions of application are valid (or Mann-Whitney if applicable). Categorical variables will be compared using a Chi2 test (or Fisher's test if validity conditions are not met).
We consider p values <0.05 to be significant. Statistical analysis will be carried out using RStudio software (version 4.2.1).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients and health professionals | Other | Other: SurveyThe intervention is a survey administered to patients and health professional. The two questionnaires are identical, with only the socio-demographic section differing. The questionnaire is composed of closed questions, scale scores and short-answer questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than or equal to 18 years
- solid organ transplant patients or health professionals working in transplantation
- no opposition to the study
Key exclusion criteria (2 listed)
- subject under guardianship or deprived of liberty
- hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySubmission of a survey to solid organ transplant patients and health professionals working in transplantation to assess their knowledge and perception of the use of artificial intelligence in transplantation | Other | patients and health professionals |
Primary outcome
Knowledge and perceptions evaluation of solid organ transplant patients and healthcare professionals working with solid organ transplantation
Time frame: 15 minutes
Analysis of the verbatim by theme and comparison of the averages of closed questions or scale questions of the questionnaire obtained by the subgroups of patients and health professionals. For scale question studying the knowledge of AI the score goes from 0 to 10 with 0 for no knowledge and 10 for perfect knowledge. A verbatim is the complete reproduction of the words spoken by the interviewee. Verbatim will be grouped by response group and compared.
6 secondary outcomes
Level of knowledge comparison between different healthcare professionals on artificial intelligence
Time frame: 15 minutes
Perceptions comparison between different healthcare professionals on artificial intelligence
Time frame: 15 minutes
Comparison of level of artificial intelligence knowledge of patients based on the transplanted organ
Time frame: 15 minutes
Comparison of the perception on artificial intelligence of patients according to the transplanted organ
Time frame: 15 minutes
Comparison of the average level of knowledge about artificial intelligence of healthcare professionals and patients.
Time frame: 15 minutes
Comparison of the levels of perception of artificial intelligence among healthcare professionals and patients
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierrick Bedouch, Pr principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Solid Organ Transplantation and Artificial Intelligence, run by University Hospital, Grenoble.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierrick Bedouch, Pr (04 76 76 79 56, pbedouch@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and perceptions evaluation of solid organ transplant patients and healthcare professionals working with solid organ transplantation (time frame: 15 minutes). 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 6 Jul 2023.