Digital Incentive Spirometry Adherence

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-27

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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Incentive spirometry is frequently prescribed as a standard-of-care for patients post-surgery to reduce the risk of developing postoperative pulmonary complications associated with atelectasis. An incentive spirometer (IS) is a mechanical breathing device that assists with pulmonary rehabilitation through improving lung expansion by encouraging deep breathing. While performing incentive spirometry exercises is effective at lowering atelectasis severity, ventilation time, and pulmonary complication rates, patient adherence to performing exercises is very poor. Medical staff, due to time constraints, often cannot supervise all of their patients' entire incentive spirometry regimens (usually every 10-15 min during wakeful hours), contributing to low adherence and incorrect exercise completion. This is compounded by current incentive spirometers lacking a method for accurately collecting patient exercise and adherence data. The present study seeks to evaluate the effect of a digital IS that provides instruction signals and exercise reminders on patients' incentive spirometry adherence.

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.

The objective of this study is to evaluate the effect of a digital IS that provides gentle auditory and haptic reminders and exercise guidance on patient adherence to incentive spirometry. Secondarily, this study will evaluate metrics relating to lung function to assess post-surgery lung recovery in patients using the digital IS.

Conditions

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Pulmonary Function Incentive Spirometry Patient Adherence Lung Resection Thoracic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single arm proof of concept study of a digital incentive spirometer

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.

Group Type EXPERIMENTAL

Adherence to digital incentive spirometer in the postop period after major chest surgery.

Intervention Type DEVICE

Major chest surgery can lead to respiratory compromise and traditional breathing exercises are not supervised or monitored. The primary objective of this study is to evaluate the effect of a multifeatured digital IS and integrated phone app on patient adherence to incentive spirometry. Together the device and app will include the following functions: an auditory and haptic reminder cue, visual and auditory cues to guide exercise completion, exercise gamification, and data tracking and visualization features.

Interventions

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Adherence to digital incentive spirometer in the postop period after major chest surgery.

Major chest surgery can lead to respiratory compromise and traditional breathing exercises are not supervised or monitored. The primary objective of this study is to evaluate the effect of a multifeatured digital IS and integrated phone app on patient adherence to incentive spirometry. Together the device and app will include the following functions: an auditory and haptic reminder cue, visual and auditory cues to guide exercise completion, exercise gamification, and data tracking and visualization features.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No