- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02628977
Sleep Health Education and Social Support Among Blacks With OSA
Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Obstructive sleep apnea (OSA), which disproportionately affects blacks (31% vs. 10%, whites), is a critical, preventable and/or treatable disease potentially causing increased cardiovascular disease (CVD) outcomes (e.g., obesity, diabetes, hypertension, stroke, arrhythmia, and chronic heart failure). Improving sleep may have direct effects in reducing CVD risk,2 enhancing brain functions, and increasing workplace productivity. Unfortunately, our focus groups suggest that most at-risk blacks are unaware of OSA symptoms or its related morbidity. Thus, it is imperative to address poor adherence among blacks with OSA, if we are to reduce health disparities associated with CVD outcomes between blacks and whites.
This is a randomized study with a total of 6 sites recruiting; 3 will serve as controls and 3 that will be intervention. Group A participants (Intervention group) will receive health education from a trained Peer Health Educator and Group B participants (Control group) will meet with a salon worker, barbershop worker, or church Health Ministry group leader. Participants will be asked to use a sleep diary and wear a home sleep test device to measure sleep for 7 days. They will be followed for 12 months.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- 180 Madison Ave
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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:
- self-reported race/ethnic minority
- ages ≥18 years
- accessible by telephone
- consent to participate, which includes permission to release medical record information
- A positive screening for OSA is necessary to be enrolled in the intervention protocol.
Exclusion Criteria:
- are involved in another sleep study.
- are unable to understand and sign this informed consent form.
- know someone who is participating in this study.
- had a heart attack or stroke within the past 12 weeks.
- do not identify yourself as a racial/ethnic minority.
- are pregnant.
- Refuse to use the ARESTM home sleep test device.
- Refuse to use the WatchPATTM home sleep test device.
- are not at risk for sleep apnea.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: OSA Health Education & Support Group
Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.
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Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.
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Comparador activo: Attention Control Group
Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.
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Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
Periodo de tiempo: 12 Months
|
We will perform analysis on an intention-to-treat basis.
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12 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of Obstructive Sleep Apnea among black men and women at the community level
Periodo de tiempo: 12 Months
|
Obstructive Sleep Apnea among minorities.
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12 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Girardin Jean Louis, MD, New York University Medical School
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-01028
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