Community Health Advocates for Motivating PAP Use in Our Neighborhoods.

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06047353
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Motivational Enhancement Therapy — BEHAVIORAL
    Motivational Enhancement Therapy (MET) is based on the principles of motivational interviewing and is designed to promote self-efficacy and maximize behavioral change. MET will be given via phone and/or in person (approximately 30 minutes) at baseline, week 1, week 2, week 4, and week 8.
  • Positive Airway Pressure (PAP) therapy — DEVICE
    Positive Airway Pressure (PAP) therapy will be administered as per standard of care.

Study Details

The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.

Key Dates

Start date
Sep 29, 2023
Status verified
Dec 2025
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Motivational Enhancement Therapy (MET)
    Participants in this group will receive intervention with MET along with PAP therapy. Participants will be in this group for approximately 3 months.
  • Active Comparator: PAP therapy
    Participants in this group will receive PAP therapy which is the standard of care. Participants will be in this group for approximately 3 months.

Primary Outcome Measure

Number of hours patient adhered to PAP therapy [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Naresh M Punjabi, MD
Naresh M Punjabi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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