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- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10016
- 180 Madison Ave
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Comparateur actif: 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.
|
Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
Délai: 12 Months
|
We will perform analysis on an intention-to-treat basis.
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12 Months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Obstructive Sleep Apnea among black men and women at the community level
Délai: 12 Months
|
Obstructive Sleep Apnea among minorities.
|
12 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Girardin Jean Louis, MD, New York University Medical School
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14-01028
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