Development and Evaluation of a Four-Week Digital Aftercare Program Following Hospital Discharge After a Thoracic Surgery.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
• 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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
University Hospital Basel Department of Thoracic Surgery
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
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)
Informations générales
University Hospital, Basel, Switzerland
+41 61 328 51 96+41 61 328 51 96
zeljko.djakovic@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
10.06.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT07044440 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Digital Follow-up Program After Discharge Home Following Thoracic Surgery (ICTRP)
Maladie en cours d'investigation
Thoracic SurgeryMobile HealthPost Operative RecoveryFollow-up (ICTRP)
Intervention étudiée
Other: digital outpatient follow-upOther: standard follow-up (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Subjective pain perception (ICTRP)
General well-being;Post-Discharge documentation of analgesic use;Emergency consultations;Readmissions;postoperative complications (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
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 secondaires
2025-00796, kt25Lardinois3 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT07044440 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible