Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182254
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-04-06
Brief Title:
Personalized Perioperative Care Based on Patient Reported Outcomes Measures
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Personalized Perioperative Care Based on Patient Reported Outcomes Measures Randomized Controlled Trial Based on the QoR-15
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPORT
Brief Summary:
In the perioperative setting Patient Reported Outcomes Measures PROMs are important for both patients and clinicians
Reliable PROMs like the Quality Of Recovery 15 QoR-15 questionnaire are available for patients experiencing surgery These PROMs are significantly used as endoints for clinical interventions assessment These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway
However data about the efficacy of PROMs-based perioperative clinical follow up are lacking
The clinical hypothesis is that a PROMs QoR-15 based perioperative clinical care is more efficient that the usual care non based on the QoR-15
Reliable PROMs like the Quality Of Recovery 15 QoR-15 questionnaire are available for patients experiencing surgery These PROMs are significantly used as endoints for clinical interventions assessment These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway
However data about the efficacy of PROMs-based perioperative clinical follow up are lacking
The clinical hypothesis is that a PROMs QoR-15 based perioperative clinical care is more efficient that the usual care non based on the QoR-15
Detailed Description:
The study is a multicenter randomized controlled trial comparing 2 groups
A control group including the usual conventional follow-up by the surgeon and the attending physician
An experimental group including in addition to the usual conventional follow-up the follow-up by nurses specialized in the evaluation of the PROMs using the french version of the QoR-15 questionnaire
A control group including the usual conventional follow-up by the surgeon and the attending physician
An experimental group including in addition to the usual conventional follow-up the follow-up by nurses specialized in the evaluation of the PROMs using the french version of the QoR-15 questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None