RecruitingNCT06352710

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project


Sponsor

Cantonal Hospital of St. Gallen

Enrollment

400 participants

Start Date

Jun 12, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality. The increasing use of smartphones offers unprecedented opportunities for data collection. The investigators developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity). By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, the investigators aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. The investigators will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. The investigators hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a smartphone app to track how patients recover over time after brain or spinal surgery, collecting self-reported information about symptoms, quality of life, and complications for up to one year after the operation. **You may be eligible if...** - You are 18 or older and scheduled for a defined brain or spinal surgery at the participating hospital - You are in a stable, non-emergency situation (not in intensive care) - You own a smartphone (Android or iPhone) and are able to use apps - You are willing to provide follow-up data for one year after surgery - You can complete a baseline quality-of-life assessment before surgery **You may NOT be eligible if...** - You are pregnant - You would have difficulty using a smartphone or the app - You have a condition that prevents reliable self-reporting - You are unable or unwilling to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROP-Tracker App

There will be no study-specific therapeutic intervention. The OP-Tracker App will be downloaded and installed on the patient's smartphone. Preoperative assessment: baseline factors such as age, gender, medical conditions, type of disease and of surgery, EQ-5D-5L. Before and after surgery surgery, SWI (Quality of life) will be assessed daily using "pop-ups"; the patient will input the value (0-10) using a slide-bar. After completion of the surgery, the app will automatically modify the number of SWI assessments over time according to the occurrence of AEs. At any point in time, the patient will be able to register an AE in the smartphone app. The patient can select the AE via a drop-down menu in the app, and can additionally input free text in case of an AE of type "other". Using a further drop-down menu, the patient will classify the AE according to the CDG and TDN grade. QoL assessments (EQ-5D-5L questionnaire) will pop up before, and at 3 and 12 months after surgery.


Locations(1)

Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, Switzerland

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NCT06352710


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