The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry (DIS)
A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- BIDMC
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Passive Arm
This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer.
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|
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adherence to prescribed post-operative incentive spirometer exercises
Časové okno: 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.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Post-Operative Pulmonary Complications
Časové okno: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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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.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Incidence of post-operative respiratory infection
Časové okno: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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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.
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Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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Incidence of clinically relevant complications
Časové okno: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
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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.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Charlie Safran, MD MS, Beth Israel Deaconess Medical Center
Publikace a užitečné odkazy
Obecné publikace
- do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.
- Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
- Warner DO. Preventing postoperative pulmonary complications: the role of the anesthesiologist. Anesthesiology. 2000 May;92(5):1467-72. doi: 10.1097/00000542-200005000-00037. No abstract available.
- THOREN L. Post-operative pulmonary complications: observations on their prevention by means of physiotherapy. Acta Chir Scand. 1954 May 5;107(2-3):193-205. No abstract available.
- Bartlett RH, Gazzaniga AB, Geraghty TR. Respiratory maneuvers to prevent postoperative pulmonary complications. A critical review. JAMA. 1973 May 14;224(7):1017-21. No abstract available.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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