Digital Incentive Spirometry Adherence

Launched by UNIVERSITY OF PENNSYLVANIA · Oct 4, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help patients breathe better after lung surgery using a digital incentive spirometer (IS) and a mobile app. The goal is to see if this device can encourage patients to use their spirometer more regularly, which is important for their recovery. The digital IS measures how deeply you breathe in and sends this information to a secure online database. The app will remind patients to use the IS, track their progress, and include fun exercises to keep them motivated.

To participate in this trial, you need to be an adult (18 years or older) who is scheduled for lung surgery and will be given an incentive spirometer as part of your standard care. You should be willing to follow all study procedures and sign a consent form. However, if you have a history of not following medical advice, significant mental health issues, or other specific medical concerns, you may not be eligible. Participants can expect support and guidance throughout the study, with plenty of opportunities to ask questions.

Gender

ALL

Eligibility 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.