Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244772
Status:
UNKNOWN
Last Update Posted:
2022-02-17
First Post:
2022-02-09
Brief Title:
Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring a Randomized Controlled Trial
Sponsor:
Onze Lieve Vrouwe Gasthuis
Organization:
Onze Lieve Vrouwe Gasthuis
Study Overview
Official Title:
Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
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:
QuReMo
Brief Summary:
Non blinded randomized controlled trial with mixed methods design To assess the experienced quality of recovery after day care surgery between patients provided with remote home monitoring and patients receiving standard discharge care
Detailed Description:
Rationale To date the majority of surgical interventions is performed in day care and patients are being discharged soon after the first critical postoperative period At home patients have limited options to contact the hospital in case of severe pain and nausea We have provided day care surgical patients with a smartphone application for remote monitoring that is configured to self-record postoperative pain and nausea after being discharged from hospital Furthermore it provides a messaging service to contact the hospital in case of severe pain or nausea Despite the promising initial patient experiences of such an application we do not know whether remote monitoring with a smartphone application improves the patients experience during the recovery period
Objective To evaluate the experienced quality of recovery after day care surgery between patients provided with a smartphone application for remote monitoring and patients receiving standard of care no remote monitoring
Study design Non-blinded randomized controlled trial with mixed methods design Study population Adult patients aged 18 years or older scheduled for day care surgery Intervention if applicable The intervention group receives the smartphone application for remote monitoring during weekdays from 8 am to 17 pm up to 7 days after surgery With this application patients are able to record experienced pain and nausea In addition they can send messages to the hospital Daily monitoring is performed by an anaesthesia professional who will contact the patient in case severe pain or nausea is reported in the app The control group receives standard of care with post-discharge verbal and paper instructions
Main study parametersendpoints The main study endpoint is the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgery Secondary endpoints are 1 the overall score on the Quality of Recovery-15 at day 1 4 and 7 post discharge 2 the perceived quality of hospital aftercare and 3 experienced psychological effects of remote monitoring during postoperative recovery from day care surgery
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participating in this study does not pose any additional risks either for patients allocated to the intervention group with remote monitoring or for patients allocated tothe standard of care group Patients in the remote monitoring group are being asked to use a smartphone application to record pain and nausea daily for up to 7 days post discharge Recording pain and nausea will take 2 minutes daily Patients from both groups are being asked to fill in the validated QoR-15 questionnaire one day before admission and on the 1st 4th and 7th day post discharge and this will take 25 minutes No extra hospital visits physical examinations or tests are required Patients in the remote monitoring group could benefit from participating in the study because they are monitored daily by a healthcare professional Therefore severe pain nausea and possibly other complications can be noticed and managed earlier
Objective To evaluate the experienced quality of recovery after day care surgery between patients provided with a smartphone application for remote monitoring and patients receiving standard of care no remote monitoring
Study design Non-blinded randomized controlled trial with mixed methods design Study population Adult patients aged 18 years or older scheduled for day care surgery Intervention if applicable The intervention group receives the smartphone application for remote monitoring during weekdays from 8 am to 17 pm up to 7 days after surgery With this application patients are able to record experienced pain and nausea In addition they can send messages to the hospital Daily monitoring is performed by an anaesthesia professional who will contact the patient in case severe pain or nausea is reported in the app The control group receives standard of care with post-discharge verbal and paper instructions
Main study parametersendpoints The main study endpoint is the difference between patients using remote monitoring and patients not using remote monitoring in perceived quality of recovery measured with the QoR-15 questionnaire on the 7th day after day care surgery Secondary endpoints are 1 the overall score on the Quality of Recovery-15 at day 1 4 and 7 post discharge 2 the perceived quality of hospital aftercare and 3 experienced psychological effects of remote monitoring during postoperative recovery from day care surgery
Nature and extent of the burden and risks associated with participation benefit and group relatedness Participating in this study does not pose any additional risks either for patients allocated to the intervention group with remote monitoring or for patients allocated tothe standard of care group Patients in the remote monitoring group are being asked to use a smartphone application to record pain and nausea daily for up to 7 days post discharge Recording pain and nausea will take 2 minutes daily Patients from both groups are being asked to fill in the validated QoR-15 questionnaire one day before admission and on the 1st 4th and 7th day post discharge and this will take 25 minutes No extra hospital visits physical examinations or tests are required Patients in the remote monitoring group could benefit from participating in the study because they are monitored daily by a healthcare professional Therefore severe pain nausea and possibly other complications can be noticed and managed earlier
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