Use of a Smartphone APP for the Management of Postoperati... | NCT06856317

Studies
Use of a Smartphone APP for the Management of Postoperative Home Recovery

NCT06856317

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Mar 4, 2025Actual

Enrollment

96Estimated

Phase

Not provided

Conditions

Rehospitalization

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2025Actual

Primary Completion Date

Jan 20, 2026Estimated

Completion Date

Feb 10, 2026Estimated

First Submitted Date

Jan 10, 2025

First Submission Date that Met QC Criteria

Feb 26, 2025

First Posted Date

Mar 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Mar 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse event rate	Complications are reported by patients using the mobile phone app.	30 days after surgery
Moderate adverse event rate	Complications are reported by patients using the mobile phone app.	30 days after surgery
Severe adverse event rate	Complications are reported by patients using the mobile phone app.	30 days after surgery
Rehospitalization rate	Rehospitalization rate in the first 30 days from home discharge.	At 30 days from surgery

Secondary Outcomes

Measure	Description	Time Frame
Non-response rate to questions asked by the application	Use of the app	Throughout the study period, an average of 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pietro Bertoglio, MD	Contact	+ 051 647 8362		pietro.bertoglio@ausl.bologna.it

Overall Officials

Name	Affiliation	Role
Pietro Bertoglio, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Azienda Ospedaliero Universitaria di Bologna	Recruiting	Bologna	Emilia-Romagna	40138	Italy