Clinical trial NCT06629454: Digital Incentive Spirometry Adherence
Official title: Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Function
Incentive Spirometry
Patient Adherence
Lung Resection
Thoracic Surgery
Keywords: Incentive spirometer
Patient adherence
Digital incentive spirometer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


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.

Primary outcomes:
measure: Total incentive spirometry adherence
timeFrame: Till discharge or up to 7 days
measure: Consistency of incentive spirometry adherence throughout postoperative stay
timeFrame: Till discharge or up to 7 days
Secondary outcomes:
measure: Volume of inspiratory breaths attempted with the digital IS
timeFrame: Till discharge or up to 7 days
measure: Blood oxygen saturation
timeFrame: Till discharge or up to 7 days
measure: Pain Scores
timeFrame: Till discharge or up to 7 days
measure: Flow rate of inspiratory breaths attempted from the digital IS
timeFrame: Till discharge or up to 7 days
Other outcomes:
measure: DLCO
timeFrame: up to 2 weeks before the surgery
measure: FEV-1
timeFrame: up to 2 weeks before the surgery
measure: FVC
timeFrame: up to 2 weeks before the surgery
measure: VC
timeFrame: up to 2 weeks before the surgery
measure: RV
timeFrame: up to 2 weeks before the surgery
measure: TLC
timeFrame: up to 2 weeks before the surgery
Locations:
city: Cherry Hill
country: United States
facility: Penn Medicine Cherry Hill
state: New Jersey
city: Berwyn
country: United States
facility: Penn Medicine Valley Forge
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine University City
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Thoracic Surgery Presbyterian
state: Pennsylvania
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
References: