Development and Evaluation of a Four-Week Digital Aftercare Program Following Hospital Discharge After a Thoracic Surgery.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
• 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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
University Hospital Basel Department of Thoracic Surgery
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
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)
Informazioni generali
University Hospital, Basel, Switzerland
+41 61 328 51 96+41 61 328 51 96
zeljko.djakovic@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
10.06.2025
(BASEC)
ID di studio ICTRP
NCT07044440 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
Digital Follow-up Program After Discharge Home Following Thoracic Surgery (ICTRP)
Malattie studiate
Thoracic SurgeryMobile HealthPost Operative RecoveryFollow-up (ICTRP)
Intervento studiato
Other: digital outpatient follow-upOther: standard follow-up (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Subjective pain perception (ICTRP)
General well-being;Post-Discharge documentation of analgesic use;Emergency consultations;Readmissions;postoperative complications (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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)
ID secondari
2025-00796, kt25Lardinois3 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT07044440 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile