RehospitalizationNCT06856317
Use of a Smartphone APP for the Management of Postoperative Home Recovery
An observational study of Rehospitalization, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehospitalization
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2025to 10 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Patients aged ≥18 years
- Patients undergoing thoracic surgery
- Patients who used the care4today app
- Obtaining informed consent to participate in the study
Who cannot join
- nothing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138
Pietro Bertoglio, MD, +051 647 8362, pietro.bertoglio@ausl.bologna.it
About this study
Official title: Use of a Smartphone APP for the Management of Postoperative Home Recovery: an Exploratory Study
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.
Read the 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.
- Conditions
- Rehospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
Complications are reported by patients using the mobile phone app.
Measured: 30 days after surgery
Moderate adverse event rate
Complications are reported by patients using the mobile phone app.
Measured: 30 days after surgery
Severe adverse event rate
Complications are reported by patients using the mobile phone app.
Measured: 30 days after surgery
Rehospitalization rate
Rehospitalization rate in the first 30 days from home discharge.
Measured: At 30 days from surgery
Secondary outcomes (1)
Non-response rate to questions asked by the application
Use of the app
Measured: Throughout the study period, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start15 Jan 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehospitalizationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Bertoglio, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856317
- Sponsor's protocol ID
- APPCHTOR
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Smartphone APP for the Management of Postoperative Home Recovery: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06856317
- Acronym / sponsor ID
- APPCHTOR
- Conditions
- Rehospitalization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- Patients aged ≥18 years
- Patients undergoing thoracic surgery
- Patients who used the care4today app
- Obtaining informed consent to participate in the study
Key exclusion criteria (1 listed)
- nothing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse event rate
Time frame: 30 days after surgery
Complications are reported by patients using the mobile phone app.
Moderate adverse event rate
Time frame: 30 days after surgery
Complications are reported by patients using the mobile phone app.
Severe adverse event rate
Time frame: 30 days after surgery
Complications are reported by patients using the mobile phone app.
Rehospitalization rate
Time frame: At 30 days from surgery
Rehospitalization rate in the first 30 days from home discharge.
1 secondary outcome
Non-response rate to questions asked by the application
Time frame: Throughout the study period, an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro Bertoglio, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehospitalization, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Bertoglio, MD (+ 051 647 8362, pietro.bertoglio@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: 30 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.