General information
  • Disease category Other (BASEC)
  • Study Phase N/A (ICTRP)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Zeljko Djakovic zeljko.djakovic@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 30.07.2025 ICTRP: Import from 10.07.2025
  • Last update 30.07.2025 09:56
HumRes66972 | SNCTP000006435 | BASEC2025-00796 | NCT07044440

Development and Evaluation of a Four-Week Digital Aftercare Program Following Hospital Discharge After a Thoracic Surgery.

  • Disease category Other (BASEC)
  • Study Phase N/A (ICTRP)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Zeljko Djakovic zeljko.djakovic@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 30.07.2025 ICTRP: Import from 10.07.2025
  • Last update 30.07.2025 09:56

Summary description of the study

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 under investigation

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)

Disease under 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)

Criteria for participation in trial
• 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)

Exclusion criteria
• 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)

Trial sites

Basel

(BASEC)

Switzerland (ICTRP)

Sponsor

University Hospital Basel Department of Thoracic Surgery

(BASEC)

Contact

Contact Person Switzerland

Zeljko Djakovic

+41 61 556 52 80 (24-Stunden-Erreichbarkeit)

zeljko.djakovic@usb.ch

Department of Thoracic Surgery, University Hospital of Basel Spitalstrasse 21, 4031 Basel, Switzerland

(BASEC)

General Information

University Hospital, Basel, Switzerland

+41 61 328 51 96+41 61 328 51 96

zeljko.djakovic@usb.ch

(ICTRP)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee northwest/central Switzerland EKNZ

(BASEC)

Date of authorisation

10.06.2025

(BASEC)


ICTRP Trial ID
NCT07044440 (ICTRP)

Official title (approved by ethics committee)
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)

Academic title
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)

Public title
Digital Follow-up Program After Discharge Home Following Thoracic Surgery (ICTRP)

Disease under investigation
Thoracic SurgeryMobile HealthPost Operative RecoveryFollow-up (ICTRP)

Intervention under investigation
Other: digital outpatient follow-upOther: standard follow-up (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
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)

not available

Primary and secondary end points
Subjective pain perception (ICTRP)

General well-being;Post-Discharge documentation of analgesic use;Emergency consultations;Readmissions;postoperative complications (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
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)

Secondary trial IDs
2025-00796, kt25Lardinois3 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT07044440 (ICTRP)

Results of the trial

Results summary

not available

Link to the results in the primary register

not available