RECRUITING

Digital Incentive Spirometry Adherence

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Conditions

Pulmonary FunctionIncentive SpirometryPatient AdherenceLung ResectionThoracic SurgeryIncentive spirometerDigital incentive spirometer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.

Official Title

Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence

Quick Facts

Study Start:2024-12-27
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06629454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, 18 years or older.
  4. 4. Undergoes any anatomic lung resection surgery
  5. 5. An incentive spirometer is expected to be ordered for the patient as standard-of-care
  6. 6. There is no restriction on active medications.
  1. 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. 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. 3. Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise.
  4. 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.

Contacts and Locations

Study Contact

Doraid Jarrar, MD
CONTACT
215-917-9693
doraid.jarrar@pennmedicine.upenn.edu

Study Locations (Sites)

Penn Medicine Cherry Hill
Cherry Hill, New Jersey, 08003
United States
Penn Medicine Valley Forge
Berwyn, Pennsylvania, 19312
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
United States
Penn Thoracic Surgery Presbyterian
Philadelphia, Pennsylvania, 19104
United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-27
Study Completion Date2025-07

Study Record Updates

Study Start Date2024-12-27
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Incentive spirometer
  • Patient adherence
  • Digital incentive spirometer

Additional Relevant MeSH Terms

  • Pulmonary Function
  • Incentive Spirometry
  • Patient Adherence
  • Lung Resection
  • Thoracic Surgery