Neoplasm, Uncertain Whether Benign or MalignantRTTNCT02851225
Coordinate Regulation of Transfusions by Uploading
A study testing telemedicine transmission of biological results in people with Neoplasm, Uncertain Whether Benign or Malignant, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Uncertain Whether Benign or Malignant
- What is being tested?
- telemedicine transmission of biological results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2019to 11 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving blood transfusions and / or platelet on our hospital
- Patient agreeing to participate in the project
Who cannot join
- A patient who can not fill questionaries.
- Absence of social coverage .
- Patient under guardianship or trusteeship safeguard justice
Trial locations and contacts
1 site in 1 country.
About this study
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.
Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).
Read more
The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.
Primary objective
- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.
Secondary objectives
- Assess the evolution of the quality of life of patients during the treatment
- Assess changes in patient satisfaction over the support
- Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
- Describe the programming time (hospitalization, consultations)
- Estimate the loss of biological results
- Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.
Read the detailed description
Setting up a Custom Care Plan for patients with conditions requiring a transfusion followed , which in its development provides a transfusion Care Custom Program .
The establishment of an electronic transmission enables the regulation of all hospitalizations throughout the patient care pathway and reinforces the link city / hospital through the receipt of laboratory results and issuing information to the partners of the care network patient. The PPST will be transmitted by secure messaging.
The primary endpoint is the proportion of transfusion episodes where PPST is respected. The proportion of patients whose care meets the PPST for 3 successive transfusion episodes will also be estimated.
The secondary endpoints are:
- The Patient satisfaction questionnaires (relative to the consideration of the results, the management procedures) in 3 successive transfusions.
- The Quality of life of the patient assessed by questionnaire (EORTC-QLQC30 and EQ5D) at baseline and after 3 successive transfusion episodes.
- The Satisfaction surveys of the medical team at home and the service effector transfusion at baseline and after 3 successive transfusion episodes.
- The Response time for a hospitalization or consultation program on the study period.
- The Number of lost biological results.
- Evaluation of the descriptive use of hospitalization, consultation, biology.
- Being tested
- telemedicine transmission of biological results
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedicine transmission of biological resultsOther
telemedicine transmission of biological informations
| Study group | Role | What they receive |
|---|---|---|
| telemedicine transmission | Experimental | telemedicine transmission of biological results in the treatment of transfusion supportive care Receives: Other: telemedicine transmission of biological results |
| without telemedicine transmission | No intervention | no telemedicine transmission of biological results in treatment in the treatment of transfusion supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of transfusion episodes in the Plan Custom Care Transfusion
The primary endpoint chosen is the proportion of transfusion episodes where the Plan Custom Care Transfusion is respected. The element determining compliance will be:
- Transfusion with remote transmission, and transfusion in a service defined in the Plan Custom Care Transfusion and transfusion with achievement of target hemoglobin levels
Measured: 12 months
Secondary outcomes (3)
Quality of life of patients
Assess the evolution of the quality of life of patients ( EORTC- QLQC30 questionnaires and EQ5D )
Measured: 12 months
Patients satisfaction
Assess changes in patient satisfaction ( satisfaction survey compared to the overall care , the inclusion of the results, the management procedures )
Measured: 12 months
Satisfaction of medical team
Assess the evolution of the satisfaction of the medical team at home and in Hospital ( satisfaction surveys )
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start2 Aug 2019
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, Uncertain Whether Benign or MalignantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Odile Beyne Rauzy, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851225
- Sponsor's protocol ID
- 12 559 15
- Acronym
- RTT
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2016
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinate Regulation of Transfusions by Uploading
- ClinicalTrials.gov ID
- NCT02851225
- Acronym / sponsor ID
- RTT / 12 559 15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.
Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).
The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.
Primary objective
- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.
Secondary objectives
- Assess the evolution of the quality of life of patients during the treatment
- Assess changes in patient satisfaction over the support
- Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
- Describe the programming time (hospitalization, consultations)
- Estimate the loss of biological results
- Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.
Detailed description
Setting up a Custom Care Plan for patients with conditions requiring a transfusion followed , which in its development provides a transfusion Care Custom Program .
The establishment of an electronic transmission enables the regulation of all hospitalizations throughout the patient care pathway and reinforces the link city / hospital through the receipt of laboratory results and issuing information to the partners of the care network patient. The PPST will be transmitted by secure messaging.
The primary endpoint is the proportion of transfusion episodes where PPST is respected. The proportion of patients whose care meets the PPST for 3 successive transfusion episodes will also be estimated.
The secondary endpoints are:
- The Patient satisfaction questionnaires (relative to the consideration of the results, the management procedures) in 3 successive transfusions.
- The Quality of life of the patient assessed by questionnaire (EORTC-QLQC30 and EQ5D) at baseline and after 3 successive transfusion episodes.
- The Satisfaction surveys of the medical team at home and the service effector transfusion at baseline and after 3 successive transfusion episodes.
- The Response time for a hospitalization or consultation program on the study period.
- The Number of lost biological results.
- Evaluation of the descriptive use of hospitalization, consultation, biology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine transmission | Experimental | Other: telemedicine transmission of biological resultstelemedicine transmission of biological results in the treatment of transfusion supportive care |
| without telemedicine transmission | No intervention | –no telemedicine transmission of biological results in treatment in the treatment of transfusion supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving blood transfusions and / or platelet on our hospital
- Patient agreeing to participate in the project
Key exclusion criteria (3 listed)
- A patient who can not fill questionaries.
- Absence of social coverage .
- Patient under guardianship or trusteeship safeguard justice
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 |
|---|---|---|
| telemedicine transmission of biological resultstelemedicine transmission of biological informations | Other | telemedicine transmission |
Primary outcome
Proportion of transfusion episodes in the Plan Custom Care Transfusion
Time frame: 12 months
The primary endpoint chosen is the proportion of transfusion episodes where the Plan Custom Care Transfusion is respected. The element determining compliance will be: - Transfusion with remote transmission, and transfusion in a service defined in the Plan Custom Care Transfusion and transfusion with achievement of target hemoglobin levels
3 secondary outcomes
Quality of life of patients
Time frame: 12 months
Patients satisfaction
Time frame: 12 months
Satisfaction of medical team
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: No
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.
Odile Beyne Rauzy, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine transmission of biological results in people with Neoplasm, Uncertain Whether Benign or Malignant, run by University Hospital, Toulouse 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 2 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 24 Aug 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?
Proportion of transfusion episodes in the Plan Custom Care Transfusion (time frame: 12 months). 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 24 Aug 2021.