The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2019-08-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the protocol is to assess how incentive spirometer data gathered via a smartphone platform can be utilized to improve participant adherence to prescribed incentive spirometer exercises in the post-operative period. Half of the participants will receive a standard of care incentive spirometer with a passive tracking device while the other half of the participants will receive a smartphone connected device and smartphone with an application that will encourage their use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Digital Incentive Spirometry Adherence

NCT06629454

Pulmonary Function Incentive Spirometry Patient Adherence +2 more

COMPLETED NA

Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure

NCT02873000

Pulmonary Complication Dyspnea Pneumonia +4 more

UNKNOWN NA

At Home Spirometry and Video Module Education for COPD Patients

NCT03834350

COPD

COMPLETED NA

Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD

NCT04795323

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE2

An Exploratory, Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in COPD Subjects

NCT03745547

Moderate Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a prospective, randomized, participant blinded, single center, clinical trial to ascertain whether a smartphone connected digital incentive spirometer, the Smartpeakflow™, can improve participant adherence to prescribed incentive spirometer exercises. A control group will be given the Beth Israel Deaconess Medical Center (BIDMC) standard Voldyne Incentive Spirometer with an attached microcontroller that will record use of the spirometer. The study group will be given the Smartpeakflow ™ connected to an android motherboard (microcomputer, aka smartphone) running Android OS, that will then record use and store this data on the smartphone itself. Participants will then use an app on the BIDMC provided smartphone to view their usage and receive encouragement to continue using their device. All data on use will be recorded locally and there will be no internet connection or communication with participant through this device at any time.

The study is designed as a technology evaluation to assess feasibility, usability and assess for early impact on our outcome measures. The investigators plan to enroll up to 50 participants to participate in this study.

At the time of enrollment, participants who meet the inclusion criteria, and none of the exclusion criteria, will be asked to opt in to the study. Participants will read information about the study and research staff will explain what it means to "opt in". Prospective participants will be given ample time to read the informed consent form and ask any questions.

Once enrolled, participants will be randomized electronically to either the study group or control group. Participants that are randomized to the control group will have no further training or instructions at the Pre-Anesthesia Testing Clinic. Participants that are in the study group will be instructed on how to use the smartphone application and device which will then be provided to them in the Post Anesthesia Care Unit after their surgery. Both groups will retain and utilize the spirometers throughout their hospital stay, and the devices will be collected by the investigators when the participant is discharged from the hospital.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Op Infection Adherence, Patient Pulmonary Atelectasis Incentive Spirometry Post-Op Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be enrolled randomly into either the passive arm or the smartphone arm prior to their surgery.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

The outcomes assessor / statistician will be blinded to which group each patient is in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Passive Arm

This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer.

Group Type NO_INTERVENTION

No interventions assigned to this group

Smartphone Arm

This arm uses a smartphone connected device and smartphone application to remind and encourage patients to use the spirometer as well as track the number of times they utilize the spirometer.

Group Type EXPERIMENTAL

Smartphone Arm

Intervention Type BEHAVIORAL

The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a "gamified" application for that patient to do so.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smartphone Arm

The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a "gamified" application for that patient to do so.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* American Society of Anesthesiologists Physical Class (ASA) 1-3 patients undergoing elective Surgery at BIDMC requiring Incentive Spirometer use in the post-op period
* Greater than 18 years of age.
* Required to have a Pre-Anesthesia Testing Clinic Appointment
* Able to understand and sign a study consent form
* Able to understand and utilize a smartphone application

Exclusion Criteria

* Diagnosis of Obstructive Sleep Apnea (OSA), treatment with CPAP or BIPAP for OSA
* Lack of regular smartphone use, or visual, mental or motor impairment that impedes use of smartphone
* Upper extremity surgery resulting in temporary or permanent inability to use two hands with spirometer device
* ASA 4 or greater, any ASA-E status (emergency surgical procedure)
* Suspected or established respiratory infection
* Previous spontaneous pneumothorax
* Severe pulmonary disease, or use of home O2
* Does not speak or understand English

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No