CPAP Adherence Pilot Study Among African Americans

MetroHealth Medical Center

Status: Enrolling

Conditions: Sleep Apnea

Treatments: Behavioral: CPAP Education; Behavioral: Usual Care; Behavioral: Telemonitoring; Behavioral: Peer Based

Study type: Interventional

Funder types: Other

Identifiers

NCT05955287

STUDY00000055

Details and patient eligibility

About

The goal of the study is to determine the feasibility of a behavioral intervention to improve CPAP adherence among African American patients with obstructive sleep apnea.

Full description

The Investigators propose to pilot test a couple-oriented intervention in a randomized controlled trial of 20 African American patients diagnosed with moderate to severe OSA and their partners. Half of the patients will receive optimal usual care currently implemented at MetroHealth, consisting of sleep therapist-initiated standardized education about OSA, sleep hygiene, and CPAP use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP utilization. Participants will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of guideline-recommended best practices for improving CPAP adherence consisting of sleep therapist-initiated standardized education for couples about OSA, sleep hygiene, and CPAP use; personalized mask fittings; and follow-up at 1 week to troubleshoot problems with CPAP utilization. Couples will participate in two couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive five 60-minute virtual cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine that will focus on enhancing couples' knowledge of CPAP, patients' self-efficacy to use CPAP, couple's relationship dynamics, and partners' skill and self-efficacy in assisting the patient with CPAP adherence.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have same bed partner(s) for at least 6 months.
• Must be at least 18 years of age

Exclusion criteria

• Must be Proficient in speaking English
• Non-compliance to management of OSA
• Apnea hypopnea Index ≥ 15 events/hours
• Terminally ill
• Mentally incompetent
• unstable housing
• need for BPAP or VPAP\PAP).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups

Couple Intervention

Experimental group

Description:

Patients will receive usual care. In addition, they will participate in virtual OSA support groups led by an African American peer-motivator patient with long-standing OSA and their bed partner. Peer-motivator couples will be trained and certified as competent prior to interacting with study participants. They will share their experiences with managing OSA including coping strategies to maximize CPAP adherence. Telemonitoring. Patients and bed partners will receive text messages encouraging CPAP adherence.

Treatment:

Behavioral: Peer Based

Behavioral: Usual Care

Behavioral: CPAP Education

Behavioral: Telemonitoring

Control

Active Comparator group

Description:

Patients with CPAP technical difficulties will be encouraged to contact the sleep technologist for assistance. Patients will also attend a 90-minute virtual webinar and question-answer session on hypertension management (1 month), cancer screening (3 months), and weight management (6 months) led by African American physicians with expertise in each topic.

Treatment:

Behavioral: Usual Care