- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01678560
Remote Monitoring in Obstructive Sleep Apnea
Remote Monitoring in Obstructive Sleep Apnea Management in Military Veterans
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prior to enrollment, patients were seen by a clinician at the Veterans Administration (VA) Hospital in West Haven, Connecticut. Either a facility-based diagnostic polysomnogram or unattended home sleep testing was performed at the evaluating clinician's discretion. Clinicians that saw the patient determined whether PAP therapy was needed, and either auto-titrating continuous positive airway pressure (CPAP) or set pressures of CPAP were ordered for the patient. Patients received education about OSA and about their equipment from a respiratory therapist and physician's assistant within the VA who then provided the equipment for them. Patients coming to this internal Durable Medical Equipment (DME) provider were screened for participation in the study.The study was overseen by the Institutional Review Board at the Veterans Affairs Connecticut Health Care in West Haven, Connecticut. Informed consent was obtained from all participants.
Patients were included in the study if they were diagnosed with OSA (defined as AHI or apnea-hypopnea index greater than five per hour with symptoms, or AHI greater than 15/hour), and if they were being exposed to PAP for the first time. Patients who were previously treated with PAP, had central apnea, chronic respiratory failure, recent in-patient hospital admissions (=< 2 weeks), or were living outside cellular network coverage area were excluded from the study.
Patients that met study inclusion criteria were provided ResMed S9 devices with wireless modems. Their usage and treatment data was tracked using EasyCare Online, a cloud-based system for the ResMed devices. After the initial setup and educational settings, the patients received supplies as needed and troubleshooting of side effects of treatment as needed. Devices were not removed after 3 months if they were not adherent.
Patients in the usual care group were monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data were only assessed by the clinician at these intervals.
Patients in the wireless care group were monitored more frequently using wireless modems as the method to obtain adherence and efficacy data.
We then determined adherence using CMS (Centers for Medicare & Medicaid Services) criteria at 3 months, and at 12 months. To obtain this data, we evaluated whether the PAP devices were used for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use, and then a consecutive 30-day period in months 4-12. We also examined the daily use from the first to last day looking of overall patterns of utilization monthly, quarterly, semiannually and annually. Data was collected and maintained in a REDCap database (REDCap is a secure web application for building and managing online surveys and databases). Sensitivity and specificity calculations were then performed to evaluate predictability of adherence at 1 year using adherence at 3 months. Fisher's exact test was also used to evaluate the association between adherence at 3 months and 1 year and the association between AHI (Apnea -Hypopnea Index) and adherence.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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West Haven, Connecticut, Estados Unidos, 06516
- VA Connecticut Health System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Newly diagnosed OSA patients
- AHI of 5/hour or greater
- Prescribed CPAP therapy
- Able to comply with treatment and understand treatment instructions
Exclusion Criteria:
- Not able to understand study requirements
- Significant cardiorespiratory disease - e.g. COPD (chronic obstructive pulmonary disease), severe CHF (congestive heart failure)
- Clinical instability at time of apnea diagnosis
- Prescribed BiPap (bilevel positive airway pressure) or ASV (Adaptive Support Ventilation), which are other types of PAP
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Usual Care
Monitoring every 3 months by face-to-face visits:These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits.
Adherence and efficacy data will only be assessed by the clinician at these intervals.
|
|
Comparador activo: Wireless Care
Frequent remote monitoring:These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
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These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months
Periodo de tiempo: First 3 months
|
Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.
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First 3 months
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Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months
Periodo de tiempo: 4-12 Months
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Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights
|
4-12 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Receiving Effective Treatment for Obstructive Sleep Apnea
Periodo de tiempo: 12 months
|
Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Meir Kryger, MD, VA Connecticut Healthcare System
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01648
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