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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10016
- 180 Madison Ave
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure
Tijdsspanne: 12 Months
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We will perform analysis on an intention-to-treat basis.
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12 Months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of Obstructive Sleep Apnea among black men and women at the community level
Tijdsspanne: 12 Months
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Obstructive Sleep Apnea among minorities.
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12 Months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Girardin Jean Louis, MD, New York University Medical School
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14-01028
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