Trial Outcomes & Findings for Digital Incentive Spirometry Adherence (NCT NCT06629454)
NCT ID: NCT06629454
Last Updated: 2025-10-20
Results Overview
Number of inspiratory breath attempts performed with the digital IS per day.
COMPLETED
NA
31 participants
Till discharge or up to 7 days
2025-10-20
Participant Flow
31 patients enrolled. 30 patients completed per protocol.
One participant was withdrawn from the study by clinician decision.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdraw by Clinician Decision
|
1
|
Baseline Characteristics
Digital Incentive Spirometry Adherence
Baseline characteristics by cohort
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Height
|
66.7 inches
n=5 Participants
|
|
Weight
|
177 pounds (lbs)
n=5 Participants
|
|
Procedure Target Lobe
Right Upper Lobe
|
10 Participants
n=5 Participants
|
|
Procedure Target Lobe
Right Lower Lobe
|
8 Participants
n=5 Participants
|
|
Procedure Target Lobe
Left Upper Lobe
|
5 Participants
n=5 Participants
|
|
Procedure Target Lobe
Left Lower Lobe
|
3 Participants
n=5 Participants
|
|
Procedure Target Lobe
Right Middle Lobe
|
1 Participants
n=5 Participants
|
|
Procedure Target Lobe
More than one lobe
|
3 Participants
n=5 Participants
|
|
Preoperative Incentive Spirometry Volume
Average preoperative volume
|
2066 milliliters
n=5 Participants
|
|
Preoperative Incentive Spirometry Volume
Maximum preoperative volume
|
2339 milliliters
n=5 Participants
|
|
Preoperative Incentive Spirometry Flow Rate
Average flow rate
|
259 milliliters per second
n=5 Participants
|
|
Preoperative Incentive Spirometry Flow Rate
Maximum flow rate
|
386 milliliters per second
n=5 Participants
|
PRIMARY outcome
Timeframe: Till discharge or up to 7 daysNumber of inspiratory breath attempts performed with the digital IS per day.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Incentive Spirometry Adherence (Breath Attempts Per Day)
|
45 Breath attempts
Interval 23.0 to 59.0
|
PRIMARY outcome
Timeframe: Till discharge or up to 7 daysNumber of hours in which at least one inspiratory breath was attempted using the digital IS per day.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)
|
7.6 Hours
Interval 5.75 to 10.0
|
SECONDARY outcome
Timeframe: Till discharge or up to 7 daysInspiratory volume in milliliters measured from one inhalation from the device
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Volume of Inspiratory Breaths Attempted With the Digital IS
Average postoperative volume
|
1314 milliliters
Interval 403.0 to 2517.0
|
|
Volume of Inspiratory Breaths Attempted With the Digital IS
Maximum postoperative volume
|
2375 milliliters
Interval 716.0 to 7506.0
|
SECONDARY outcome
Timeframe: Till discharge or up to 7 daysAverage postoperative SpO2 per patient. Mean is the mean across the patient cohort.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Blood Oxygen Saturation
|
96 percentage of oxygen saturation
Interval 93.0 to 98.0
|
SECONDARY outcome
Timeframe: Till discharge or up to 7 daysPostoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain). These are then averaged per patient. Mean and range is reported for the entirely of the patient cohort.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Pain Scores
|
4 units on a scale from 0 to 10
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Till discharge or up to 7 daysFlow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Average flow rate
|
186 Milliliters per second
Interval 132.0 to 288.0
|
|
Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Maximum flow rate
|
357 Milliliters per second
Interval 172.0 to 405.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPreoperative diffusing capacity of the lung for carbon monoxide to move from air sacs into the bloodstream as a percent of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=26 Participants
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.
|
|---|---|
|
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
|
79.0 percentage of predicted value
Interval 26.1 to 124.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPreoperative forced expiration volume in 1 second as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Forced Expiratory Volume in 1 Second (FEV-1)
|
90.6 percentage of predicted value
Interval 21.5 to 129.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPreoperative forced vital capacity of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=30 Participants
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.
|
|---|---|
|
Forced Vital Capacity (FVC)
|
94.4 percentage of predicted value
Interval 66.3 to 135.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPopulation: This metric was not collected as part of standard of care pulmonary function testing.
Preoperative vital capacity of the lungs.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPreoperative residual volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=20 Participants
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.
|
|---|---|
|
Residual Volume (RV)
|
108 percentage of predicted value
Interval 75.3 to 203.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryPreoperative total lung capacity as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=25 Participants
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.
|
|---|---|
|
Total Lung Capacity (TLC)
|
94.1 percentage of predicted value
Interval 74.3 to 123.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryForced expiratory flow rate between 25% and 75% of the forced vital capacity, pre-bronchodilator, as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=23 Participants
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.
|
|---|---|
|
Forced Expiratory Flow (FEF25-75)
|
93.9 percentage of predicted value
Interval 8.2 to 189.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryTotal gas volume within the chest cavity when the airway is temporarily blocked as a percent of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=12 Participants
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.
|
|---|---|
|
Thoracic Gas Volume (TGV)
|
99.9 percentage of predicted value
Interval 74.7 to 155.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2 weeks before the surgeryExpiratory reserve volume of the lungs as a percentage of predicted value based on the person's age, sex, height, and other factors.
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=14 Participants
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.
|
|---|---|
|
Expiratory Reserve Volume (ERV)
|
95.5 percentage of predicted value
Interval 29.8 to 166.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On the day of patient discharge from the hospital, an average of 3 daysDevice engagement survey responses. Patients are instructed on the paper survey to "Circle how much you agree or disagree with the following statements:"
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=24 Participants
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.
|
|---|---|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Strongly Agree
|
14 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Agree
|
6 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Neutral
|
1 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Disagree
|
1 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Strongly Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Incomplete
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to know when to do my exercises with my device. · Not applicable
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Strongly Agree
|
7 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Agree
|
10 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Neutral
|
5 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Strongly Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Incomplete
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I felt motivated to do my exercises. · Not applicable
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Strongly Agree
|
14 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Agree
|
10 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Neutral
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Strongly Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Incomplete
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
It was easy to click the button on my device to start an exercise when I wanted to. · Not applicable
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Strongly Agree
|
9 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Agree
|
8 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Neutral
|
3 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Disagree
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Strongly Disagree
|
1 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Incomplete
|
1 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how the device gave spoken (audio) instructions for the exercises. · Not applicable
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Strongly Agree
|
11 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Agree
|
8 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Neutral
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Strongly Disagree
|
1 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Incomplete
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked how my nurse/doctor could see my breathing exercise measurements. · Not applicable
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Strongly Agree
|
6 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Agree
|
5 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Neutral
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Strongly Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Incomplete
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I was able to set up the app easily. · Not applicable
|
11 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Strongly Agree
|
3 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Agree
|
6 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Neutral
|
3 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Strongly Disagree
|
0 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Incomplete
|
2 Participants
|
|
Discharge Survey Responses - Device Engagement
I liked the app features. · Not applicable
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On the day of patient discharge from the hospital, an average of 3 daysHave you used an incentive spirometer prior to this hospital stay?
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=24 Participants
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.
|
|---|---|
|
Discharge Survey Responses - Previous Incentive Spirometry
YES
|
7 Participants
|
|
Discharge Survey Responses - Previous Incentive Spirometry
NO
|
12 Participants
|
|
Discharge Survey Responses - Previous Incentive Spirometry
Incomplete
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: On the day of patient discharge from the hospital, an average of 3 daysDischarge Survey Question: How much of you exercises do you think you completed?
Outcome measures
| Measure |
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
n=24 Participants
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.
|
|---|---|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
0-20%, Close to none
|
0 Participants
|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
21-40%, A few of them
|
2 Participants
|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
41-60%, Around half
|
7 Participants
|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
61-80%, More than half
|
9 Participants
|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
81-100%, Almost all
|
6 Participants
|
|
Discharge Survey Responses - Exercise Completion Self-Reported Adherence
Incomplete
|
0 Participants
|
Adverse Events
Single Arm Proof of Concept Study of a Digital Incentive Spirometer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place