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Completed

NCT Number: NCT03686631

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

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.

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Key information

Conditions

Post-Op Infection Adherence, Patient Behavior Health Behavior Incentive Spirometry Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Post-Op Complication Postoperative Complications Pulmonary Atelectasis Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIDMC

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Arm

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.

Primary outcomes

  1. Adherence to prescribed post-operative incentive spirometer exercises

    Time frame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

    The primary outcome of the study will be a measure of how adherent the participant has been to the prescribed post-operative incentive spirometer exercises. Participants are prescribed ten breathing exercises per hour using the spirometer and the electronic devices in both arms will record how often the participant utilizes the device, measured on an hourly basis.

Secondary outcomes

  1. Incidence of Post-Operative Pulmonary Complications

    Time frame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

    Pulmonary related complications and events such as radiographic exams, increased utilization of oxygen therapy, use of accessory breathing devices (BiPAP, CPAP). The measure will be dichotomous outcome based on whether event took place or not.

  2. Incidence of post-operative respiratory infection

    Time frame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

    Diagnosis of respiratory infection, such as pneumonia, in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not.

  3. Incidence of clinically relevant complications

    Time frame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

    Diagnosis of clinically relevant complications such as surgical site infection, falls, delerium, or any other non-pulmonary event in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence

Acronym: DIS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2018
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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