NCT06856317

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

March 4, 2025

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

January 10, 2025

Last Update Submit

February 26, 2025

Conditions

Rehospitalization

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Non-response rate to questions asked by the application

    Throughout the study period, an average of 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • nothing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Study Officials

  • Pietro Bertoglio, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Bertoglio, MD

CONTACT

+ 051 647 8362pietro.bertoglio@ausl.bologna.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

March 4, 2025

Study Start

January 15, 2025

Primary Completion

January 20, 2026

Study Completion

February 10, 2026

Last Updated

March 4, 2025

Record last verified: 2024-12

Locations

IT(1)