To assess 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).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Dagbehandeling chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the overall score on the Quality of Recovery-15
questionnaire (QoR-15) at post discharge day 4.
Secondary outcome
Secondary endpoints are the overall score on the Quality of Recovery-15 at
day*s 1 and 7 post discharge.
Background summary
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 to self-record postoperative pain and nausea after being
discharged from hospital. Furthermore, it provides a tool to immediately
contact the hospital in case of (severe) pain or nausea. Despite the promising
initial patient experiences of this application, we do not know whether is
improves the patients experience of the recovery period.
Study objective
To assess 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
Intervention
The intervention group receives remote monitoring during weekdays from 8 am to
17 pm up to 7 days postoperative by providing them a smartphone application.
With this application, patients are able to record experienced pain and nausea.
In-addition they can send a text 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).
Study burden and risks
Participating in this study does not pose any additional risks for patients
allocated to either the intervention group with remote monitoring or for
patients allocated to the 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 this will take 2.5 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.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
Age: older than or equal to 18 years
Pre-anaesthesia conclusion: ASA I to III
Speaking and understanding of the Dutch language
Scheduled for day care surgery
In possession of a smartphone
Exclusion criteria
Age: younger than 18 years
Pre-anaesthesia conclusion: ASA >= IV
Not able to speak or understand the Dutch language
Mentally impaired (e.g. dementia, retardation)
Scheduled for non-day care surgery with discharge the next day following the
day of the surgical intervention
Not in possession of a smartphone
During study:
Patients who experience a unexpected post-operative complication or prolonged
recovery with the result that discharge on the same day of the surgical
intervention is not possible will be excluded
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05244772 |
| CCMO | NL78144.100.21 |