Development and Evaluation of a Four-Week Digital Aftercare Program Following Hospital Discharge After a Thoracic Surgery.
Zusammenfassung der Studie
After a thoracic surgery, routine aftercare examinations are conducted two and four weeks after hospital discharge to ensure that your recovery proceeds optimally. In this study, we investigate how and whether an additional four-week digital aftercare program is effective and if it can contribute to improving your physical, mental, and overall well-being, thereby preventing adverse events. Participation in this study lasts for 4 weeks (=28 days) (+/- 3 days). If you decide to participate, we ask all study participants to complete a digital questionnaire upon hospital discharge (taking less than 1 minute) and to fill out a digital questionnaire during the two routine aftercare examinations, 14 and 28 days (+/- 3 days) after discharge, which takes about 2 minutes each. If you choose to participate, you will be randomly assigned to one of two groups. You will either be in the group receiving the new aftercare program or in the standard aftercare group. In the four-week digital aftercare program group, you will receive a digital questionnaire two days after discharge and then every third day (a total of 7-8), which takes 1-2 minutes to complete. Additionally, in this group, you will have the opportunity to contact us anytime via 'active feedback' via email. If necessary, we will contact you by phone to discuss the next steps. At the end of the study, you will evaluate whether the digital aftercare program helped you in your recovery.
(BASEC)
Untersuchte Intervention
During the routine outpatient aftercare examinations 14 and 28 days (+/- 3 days) after hospital discharge, all study participants fill out a digital questionnaire regarding their health status and general well-being. Patients in the group with the digital aftercare program will also receive a digital aftercare questionnaire via email starting from the second day after discharge at three-day intervals until the outpatient aftercare examination 14 days (+/- 3 days) after discharge, and are asked to complete it. After this outpatient aftercare examination, patients in the digital aftercare program will continue to receive questionnaires every 3 days for the remainder of the 28-day follow-up period after hospital discharge. Furthermore, they can request a phone contact from a physician in our department at any time within 28 days after discharge. At the end of the digital aftercare program, patients will fill out a satisfaction questionnaire to evaluate their overall experience.
(BASEC)
Untersuchte Krankheit(en)
In this study, we investigate whether patients after thoracic surgery can be supported in their recovery process with an additional four-week digital aftercare program. We also examine whether the digital aftercare program has a positive impact on the physical, mental, and overall well-being of the patients and whether it can help prevent adverse events.
(BASEC)
• Patients who own a smartphone or PC and have an email account and are able to complete a digital questionnaire. Or an immediate caregiver in the same household has a smartphone or PC and is familiar with its use. • Patients who are proficient in German or French, both spoken and written. • Patients who are being discharged home. (BASEC)
Ausschlusskriterien
• Patients under preoperative opioid/corticosteroid therapy. • Patients who cannot follow the study protocol, e.g., due to insufficient German or French language skills, mental disorders, dementia, etc. • Patients with polytrauma or who have undergone mediastinoscopy. (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
University Hospital Basel Department of Thoracic Surgery
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Zeljko Djakovic
+41 61 556 52 80 (24-Stunden-Erreichbarkeit)
zeljko.djakovic@clutterusb.chDepartment of Thoracic Surgery, University Hospital of Basel Spitalstrasse 21, 4031 Basel, Switzerland
(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland
+41 61 328 51 96+41 61 328 51 96
zeljko.djakovic@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
10.06.2025
(BASEC)
ICTRP Studien-ID
NCT07044440 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The development and evaluation of a digital follow-up program during the initial four weeks after discharge home following thoracic surgery. A confirmatory, single-center, prospective, non-blinded, randomized, controlled study (BASEC)
Wissenschaftlicher Titel
The Development and Evaluation of a Digital Follow-up Program During the Initial Four Weeks After Discharge Home Following Thoracic Surgery. A Confirmatory, Single-center, Prospective, Non-blinded, Randomized, Controlled Study (ICTRP)
Öffentlicher Titel
Digital Follow-up Program After Discharge Home Following Thoracic Surgery (ICTRP)
Untersuchte Krankheit(en)
Thoracic SurgeryMobile HealthPost Operative RecoveryFollow-up (ICTRP)
Untersuchte Intervention
Other: digital outpatient follow-upOther: standard follow-up (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Patients who have signed an informed consent form and underwent a surgery performed
at the Thoracic Surgery Department of the University Hospital Basel
- Age = 18 years at the time of informed consent
- First participation in the Study
- Patient operated under general anesthesia
- Patients who are in possession of a smart phone or personal computer and have an
e-mail account and are able to answer a digital questionnaire. Or an immediate
caretaker in the same household owns a smartphone or personal computer and is
familiar with the use
- Patients who understand verbal and written German or French
- Patients discharged at home after surgery
- Hospital stay > 3 nights after surgery
Exclusion Criteria:
- Patients under preoperative opioid/cortisone therapy
- Patients who are unable to follow the procedure of the study, e. g. read or
understand German or French, psychological disorders, dementia, etc.
- Enrolment of the investigator, his/her family members, employees and other dependent
person
- Patients with polytrauma or who underwent mediastinoscopy (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Subjective pain perception (ICTRP)
General well-being;Post-Discharge documentation of analgesic use;Emergency consultations;Readmissions;postoperative complications (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Didier Lardinois, Prof. MDZeljko Djakovic, MDZeljko Djakovic, MD, zeljko.djakovic@usb.chzeljko.djakovic@usb.ch, +41 61 328 51 96+41 61 328 51 96, University Hospital, Basel, Switzerland (ICTRP)
Sekundäre IDs
2025-00796, kt25Lardinois3 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT07044440 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar