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

22 september 2019 bijgewerkt door: Charles Safran, Beth Israel Deaconess Medical Center

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • BIDMC

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Passive Arm
This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence to prescribed post-operative incentive spirometer exercises
Tijdsspanne: 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.
Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Post-Operative Pulmonary Complications
Tijdsspanne: 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.
Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
Incidence of post-operative respiratory infection
Tijdsspanne: 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.
Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
Incidence of clinically relevant complications
Tijdsspanne: 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.
Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beth Israel Deaconess Medical Center

Onderzoekers

  • Hoofdonderzoeker: Charlie Safran, MD MS, Beth Israel Deaconess Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juli 2019

Primaire voltooiing (Werkelijk)

14 augustus 2019

Studie voltooiing (Werkelijk)

14 augustus 2019

Studieregistratiedata

Eerst ingediend

21 september 2018

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2018

Eerst geplaatst (Werkelijk)

27 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2019

Laatste update ingediend die voldeed aan QC-criteria

22 september 2019

Laatst geverifieerd

1 september 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2018P000230

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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