Quality of Recovery After Day Care Surgery With App Controlled Remote Monitoring: a Randomized Controlled Trial
QuReMo
1 other identifier
interventional
230
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFebruary 17, 2022
February 1, 2022
4 months
February 9, 2022
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Recovery
To assess 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 surgey
7th day after day care surgery
Secondary Outcomes (7)
Postoperative pain
1st, 4th and 7th day after day care surgery
Post discharge nausea and vomiting
1st, 4th and 7th day after day care surgey
Surgical complications
1st 4th and 7th day after day care surgey
Re-admissions
1st, 4th and 7th day after day care surgery
Contact with healthcare professionals
1st, 4th and 7th day after day care surgey
- +2 more secondary outcomes
Study Arms (2)
Remote monitoring
EXPERIMENTALAt discharge, patients in the remote monitoring group receive verbal and paper care- and recovery instructions from a day care ward nurse and in adittion they will have a monitoring application installed on theirpersonal smartphone. Once they are back home, they can start recording pain and nausea and ask questions about their recovery with the application and report back the anaesthesia backoffice.
Standard care
NO INTERVENTIONAt discharge, patients in the standard care group receive verbal and paper care- and recovery instructions from a day care ward nurse.
Interventions
Remote monitoring with a smartphone application of pain and nausea after day care surgery
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age: older than or equal to 18 years
- Pre-anaesthesia conclusion: ASA I to III
- Scheduled for day care surgery for one of the following surgical specialties:
- gynaecology, eye-nose and throat, oral and maxillofacial, orthopaedics, general and vascular, trauma and urology -In possession of a smartphone
You may not qualify if:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Not able to speak or understand the Dutch language
- Mentally impaired (e.g. dementia, retardation)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CWZ Hospital
Nijmegen, Limburg, 6532 SZ, Netherlands
OLVG Hospital
Amsterdam, North Holland, 1091AC, Netherlands
Maasstad Hospital
Rotterdam, South Holland, 3079 DZ, Netherlands
Related Publications (2)
Thiel B, Godfried M, van Emst M, Vernooij L, van Vliet L, Rumke E, Snoeck M, Koopman S, Kalkman C. Discharge with a smartphone application for follow-up after day care surgery: a randomised controlled trial. BJA Open. 2025 Sep 25;16:100489. doi: 10.1016/j.bjao.2025.100489. eCollection 2025 Dec.
PMID: 41079519DERIVEDThiel B, Godfried MB, van Emst ME, Vernooij LM, van Vliet LM, Rumke E, van Dongen RTM, Gerrits W, Koopman JSHA, Kalkman CJ. Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial. Trials. 2023 Feb 9;24(1):102. doi: 10.1186/s13063-023-07121-6.
PMID: 36759858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Godfried, PhD
OLVG Hospital
- PRINCIPAL INVESTIGATOR
Seppe Koopman, PhD
Maasstad Hospital
- PRINCIPAL INVESTIGATOR
Robert van Dongen, PhD
CWZ Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 17, 2022
Study Start
March 1, 2022
Primary Completion
July 1, 2022
Study Completion
December 1, 2022
Last Updated
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Available december 2022
- Access Criteria
- Request for information can be adressed to b.thiel@olvg.nl.
The study will be registered before inclusion of the first patient on www.clinicaltrials.gov. The results of the study will find their way into (inter-) national scientific journals and guidelines. We will submit analyses to scientific journals in the field of anaesthesiology.