Using a digital spirometer to improve patient adherence after lung surgery
Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence
This study tests whether a digital spirometer and a mobile app can help patients stick to their breathing exercises after lung surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 6 sites (Cherry Hill, New Jersey and 5 other locations) |
| Trial ID | NCT06629454 on ClinicalTrials.gov |
What this trial studies
This proof-of-concept study evaluates the effectiveness of a digital incentive spirometer and a mobile app designed to enhance adherence to spirometry exercises in patients recovering from lung surgery. The device tracks inspiratory breaths and sends data to a secure cloud database, while the app includes reminders, gamification, and progress tracking features to encourage usage. The goal is to determine if these digital tools can improve patient compliance with post-operative respiratory care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled to undergo anatomic lung resection surgery and are expected to use an incentive spirometer post-operatively.
Not a fit: Patients with significant psychiatric conditions or those unable to provide informed consent due to incapacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients undergoing lung surgery by improving adherence to respiratory exercises.
How similar studies have performed: While the use of digital health tools in post-operative care is gaining traction, this specific approach to enhancing spirometry adherence is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, 18 years or older. 4. Undergoes any anatomic lung resection surgery 5. An incentive spirometer is expected to be ordered for the patient as standard-of-care 6. There is no restriction on active medications. Exclusion Criteria: There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study: 1. Vulnerable populations who in the opinion of the investigator are unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. 2. History of prior non-compliance to prescribed therapy or presence or history of significant psychiatric condition (e.g., drug or alcohol addiction, psychosis, schizophrenia), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions. 3. Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise. 4. Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.
Where this trial is running
Cherry Hill, New Jersey and 5 other locations
- Penn Medicine Cherry Hill — Cherry Hill, New Jersey, United States (Recruiting)
- Penn Medicine Valley Forge — Berwyn, Pennsylvania, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Penn Medicine University City — Philadelphia, Pennsylvania, United States (Recruiting)
- Penn Thoracic Surgery Presbyterian — Philadelphia, Pennsylvania, United States (Recruiting)
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Doraid Jarrar, MD
- Email: doraid.jarrar@pennmedicine.upenn.edu
- Phone: 215-917-9693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.