Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial.

التفاصيل البيبلوغرافية
العنوان:	Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial.
المؤلفون:	Mak S; Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States., Ash G; Section of General Internal Medicine, Yale School of Medicine, New Haven, CT, United States.; Section of Biomedical Informatics and Data Science, Yale School of Medicine, New Haven, CT, United States.; Center for Pain, Research, Informatics, Medical Comorbidities and Education Center (PRIME), VA Connecticut Health System, West Haven, CT, United States., Liang LJ; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States., Der-McLeod E; Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States.; Geriatric Research Education and Clinical Center, North Hills, CA, United States., Ghadimi S; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.; Geriatric Research Education and Clinical Center, North Hills, CA, United States., Kewalramani A; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.; Sleep Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States., Naeem S; Sleep Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States., Zeidler M; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.; Sleep Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States., Fung C; Center for the Study of Healthcare Innovation, Implementation and Policy (CSHIIP), VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States.; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States.; Geriatric Research Education and Clinical Center, North Hills, CA, United States.; Sleep Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States.
المصدر:	JMIR research protocols [JMIR Res Protoc] 2024 Sep 19; Vol. 13, pp. e60769. Date of Electronic Publication: 2024 Sep 19.
نوع المنشور:	Journal Article; Randomized Controlled Trial; Clinical Trial Protocol
اللغة:	English
بيانات الدورية:	Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Internet ISSN: 1929-0748 (Electronic) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: MEDLINE
أسماء مطبوعة:	Original Publication: Toronto : JMIR Publications
مواضيع طبية MeSH:	Sleep Apnea, Obstructive/therapy , Continuous Positive Airway Pressure/instrumentation , Continuous Positive Airway Pressure/methods , Wearable Electronic Devices, Humans ; Pilot Projects ; Female ; Male ; Adult ; Single-Blind Method ; Middle Aged ; Patient Compliance
مستخلص:	Background: Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), nonadherence is common. Numerous factors influence PAP use, including a belief that the therapy is important and effective. In theory, providing information to patients about their blood oxygen levels during sleep (which may be low when PAP is not used), juxtaposed to information about their PAP use, may influence a patient's beliefs about therapy and increase PAP use. With the advent of consumer wearable smartwatches' blood oxygen saturation monitoring capability (and the existing routine availability of PAP use data transmitted via modem to clinical dashboards), there is an opportunity to provide this combination of information to patients. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of the Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP), a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA in a pilot randomized waitlist-controlled clinical trial. Methods: This is a single-blinded randomized controlled trial. We will randomize 50 individuals with a history of OSA, who receive care from a Department of Veterans Affairs medical center in the Los Angeles area and are nonadherent to prescribed PAP therapy, into either an immediate intervention group or a waitlist control group. During a 28-day intervention, the participants will wear a study-provided consumer wearable device and complete a weekly survey about their OSA symptoms. A report that summarizes consumer wearable-provided oxygen saturation values, PAP use derived from modem data, and patient-reported OSA symptoms will be prepared weekly and shared with the patient. The immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; 1 week after treatment for the immediate intervention group and repeat baseline for the waitlist control group) and week 11 (T5; follow-up for the immediate intervention group and 1 week after treatment for the waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes per night) from T1 to T3. The primary analysis will be a comparison of the primary outcome between the immediate intervention and the waitlist control groups (intention-to-treat design), using a 2-sample, 2-sided t test on change scores (unadjusted). Results: Recruitment began in October 2023. Data analysis is expected to begin in October 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis. Conclusions: Findings from the study may provide additional insights on how patients with OSA might use patient-generated health data collected by consumer wearables to inform self-management of OSA and possibly increase their use of PAP therapy. Trial Registration: ClinicalTrials.gov NCT06039865; https://clinicaltrials.gov/study/NCT06039865. International Registered Report Identifier (irrid): DERR1-10.2196/60769. (©Selene Mak, Garrett Ash, Li-Jung Liang, Erin Der-McLeod, Sara Ghadimi, Anjali Kewalramani, Saadia Naeem, Michelle Zeidler, Constance Fung. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.09.2024.)
معلومات مُعتمدة:	K01 DK129441 United States DK NIDDK NIH HHS
فهرسة مساهمة:	Keywords: adherence; consumer wearables; mobile phone; self-management; sleep apnea
سلسلة جزيئية:	ClinicalTrials.gov NCT06039865
تواريخ الأحداث:	Date Created: 20240829 Date Completed: 20240919 Latest Revision: 20240919
رمز التحديث:	20240920
DOI:	10.2196/60769
PMID:	39207912
قاعدة البيانات:	MEDLINE

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تدمد:	1929-0748
DOI:	10.2196/60769