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Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea

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Ce qui est testé

Peer-Buddy System

+ Usual Care

Autre
Qui peut participer

Apnée+6

+ Maladies du système nerveux

+ Troubles respiratoires

De 21 à 85 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Soins de support

Interventionnel
Date de début : novembre 2017
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Résumé

Sponsor principalUniversity of Arizona
Contacts de l'étudeSairam Parthasarathy, MD
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 17 novembre 2017

Date à laquelle le premier participant a commencé l'étude.

OSA affects 7 to 12% of the US population and is an independent risk factor for several clinical consequences such as systemic hypertension, cardiovascular disease, stroke, reduced HR-QOL, increased all-cause mortality, and motor vehicle accidents due to sleepiness. However, OSA and other sleep disorders are woefully underdiagnosed because of time constraints at the PCP's office. Such poor CPAP adherence is associated with increased risk for fatal and non-fatal cardiovascular events. CPAP therapy has been associated with up to 3-fold reduction in fatal and non-fatal cardiovascular events in both on-treatment analysis of RCTs and observational studies. CPAP therapy is associated with 7-fold reduction in sleepiness-related accidents. The overarching aim of this proposal is to institute a multi-level strategy aimed at improving guideline based care for OSA in populations with health disparities. The overarching aim of the program of research is to eventually institute a multi-level strategy with interventions aimed at both providers and patients in order to improve guideline based care for OSA in populations with health disparities. Specifically, in order to address the under-diagnosis of OSA, an electronic health record (EHR) based predictive analytics system will be implemented. A similar EHR-based alert system with reflex order sets for initiating testing for OSA that the investigators have developed will enable PCPs to effectively diagnose and treat OSA. It was found that in a nationally representative dataset of \~220,000 patients, lower neighborhood income was associated with lower CPAP adherence. Considering the time and access-related barriers in the PCP office, it is believed that such socioeconomic status (SES) related differences in CPAP adherence needs to be addressed by culturally-competent peer educators (such as promotors) with OSA serving as "peer-buddies". In a recent multi-site RCT, it was found that CPAP adherence and patient satisfaction was improved by peer-driven intervention through an interactive voice response system (PDI-IVR; PCORI-IHS-1306-02505), whereby the peers shared their experiences with CPAP naïve patients and educated them about OSA and risks of CPAP nonadherence. Whether PDI-IVR can improve adherence in underserved population in low resource clinics is unclear. In this proposal, 110 CPAP naïve patients and 35 experienced peer-buddies will be recruited in from a large healthcare system that provides care for an underserved population with an excess burden of sleep disorders (Medicaid and dual-eligible Medicare beneficiaries). This study will address health disparities in the diagnosis and treatment of OSA using a patient-level educational intervention (PDI-IVR system) targeting patients and thereby promote health equity. This proposal will also inform future studies by gathering additional data on the effect of PDI-IVR on adherence to sleep study testing and CPAP adherence in an underserved population in low resource clinics. Specific Aim #1: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve adherence to sleep study testing in a lower socioeconomic population. Hypothesis #1: A PDI-IVR support system will lead to greater adherence to sleep study testing in patients with OSA when compared to patients receiving conventional education. Specific Aim #2: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve CPAP treatment adherence in a lower socioeconomic population. Hypothesis #2: A PDI-IVR support system will lead to greater adherence to CPAP therapy in patients with OSA when compared to patients receiving conventional education.

Titre officielPredictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
NCT03345524
Sponsor principalUniversity of Arizona
Contacts de l'étudeSairam Parthasarathy, MD
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

145 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Soins de support

Cette étude teste des approches visant à améliorer le confort, le bien-être ou la qualité de vie des personnes atteintes d'une maladie, notamment en aidant à mieux gérer les symptômes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 21 à 85 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

ApnéeMaladies du système nerveuxTroubles respiratoiresMaladies des voies respiratoiresTroubles du sommeil-éveilSyndromes d'apnée du sommeilApnée du sommeil obstructiveTroubles du sommeil intrinsèquesDyssomnies

Critères

Inclusion Criteria for Subject: * Referral for sleep study testing for possible OSA * Medicaid and dual-eligible Medicare beneficiaries * Household income in the bottom national quartile of household median income Inclusion Criteria for Peer Buddy: * Adherent to CPAP therapy (greater than or equal to 4 hours per night of CPAP use) * Willing to meet with peer-buddy on 2-4 occasions in-person * Has a cell phone or other reliable telephone line * Willing to undergo one-two training and orientation session(s) and pass a subsequent mock patient interaction Exclusion Criteria for Subject: * Central sleep apnea (CSA) * Participation in another intervention-based research study * Patient's primary care provider refuses patient participation for medical instability Exclusion Criteria for Peer Buddy: * Central sleep apnea (CSA) * Participation in another intervention-based research study * Patient's primary care provider refuses patient participation for medical instability * Major depression or other major psychiatric illness * Shift-worker or frequent out of town traveler

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training

Groupe II

Comparateur actif
Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

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Cette étude comporte 1 site

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University of Arizona

Tucson, United StatesOuvrir University of Arizona dans Google Maps
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