Clinical trial NCT06856317: Use of a Smartphone APP for the Management of Postoperative Home Recovery
Official title: Use of a Smartphone APP for the Management of Postoperative Home Recovery: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rehospitalization
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study, the researchers expect to enroll the 96 patients who participated in the trial period of the application.

Considering the 30-day incidence and re-hospitalization rates as sample proportions of 0.5 (most conservative assumption), a numerosity of 96 will be sufficient to estimate the proportions with bilateral 95% confidence intervals of 0.2.

The width of the confidence interval was calculated using PASS 2023, version 23.0.2.

Brief summary: To calculate the incidence rates of postoperative adverse events (moderate and severe) and rehospitalization in patients undergoing thoracic surgery followed in follow-up using a smartphone application.

Detailed description: This is an observational, exploratory, cohort, retrospective study. For this study, data acquired on patients who participated in the trial period of the app will be retrospectively analyzed. Our Operating Unit used the care4today app on a trial basis during the period between March 1 and October 31, 2023, focusing on monitoring the first 30 days after discharge. The app was offered to patients scheduled for thoracic surgery involving access to the pleura. After a few setup questions, the app was activated upon discharge. For the first 15 days it sent daily questions via notification regarding general health status, postoperative pain, respiratory capacity, and resumption of activities. From day 15 to day 30 after discharge, questions were asked every 4 days. All relevant responses were forwarded via e-mail to the clinician in the form of an orange or red alert in relation to lesser or greater severity.

Patients were treated according to clinical practice in accordance with the clinician's judgment and the information in the Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. Informed consent will be collected during follow-ups.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Patients undergoing thoracic surgery
* Patients who used the care4today app
* Obtaining informed consent to participate in the study

Exclusion Criteria:

* nothing

Primary outcomes:
measure: Adverse event rate
timeFrame: 30 days after surgery
measure: Moderate adverse event rate
timeFrame: 30 days after surgery
measure: Severe adverse event rate
timeFrame: 30 days after surgery
measure: Rehospitalization rate
timeFrame: At 30 days from surgery
Secondary outcomes:
measure: Non-response rate to questions asked by the application
timeFrame: Throughout the study period, an average of 30 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna
state: Emilia Romagna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pietro Bertoglio, MD
role: PRINCIPAL_INVESTIGATOR
References: