CPAP Adherence Pilot Study Among African Americans

NCT05955287 | Unknown

• 1 other identifier: STUDY00000055
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea

Keywords

obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• CPAP Adherence

  Mean hours per night of CPAP use

  3 months

Secondary Outcomes (3)

• Sleep Apnea Quality of Life

  3 months

• Patient and Partner Sleepiness

  3 months

• Patient and Partner Quality of Sleep

  3 months

Study Arms (2)

Couple Intervention

EXPERIMENTAL

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.

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

Control

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

Telemonitoring BEHAVIORAL

Text messages of encouragement will be sent to patients and partners. No more than 2 messages will be sent per week to prevent respondent fatigue.

Couple Intervention

Peer Based BEHAVIORAL

Patients and partners will attend OSA virtual support groups led by an African American 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.

Couple Intervention

CPAP Education BEHAVIORAL

Patients with OSA and their bed partners will participate in two 1-hour video support groups at 2 weeks and 2 months ran by patients with OSA and their bed partners

Couple Intervention

Usual Care BEHAVIORAL

Participants will receive OSA education and CPAP training from providers trained in OSA management.

Control; Couple Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical System

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• John D Thornton, MD, MPH

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John D Thornton, MD,MPH

CONTACT

216-778-3732; dthornton@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Center for Reducing Health Disparities Co-Director of Education, Population Health Research Institute Director, Medical Intensive Care Unit Associate Professor, Department of Internal Medicine

Model Details: In the intervention group, patients with OSA and their bed partners will participate in two 1-hour video support groups at 2 weeks and 2 months ran by patients with OSA and their bed partners. Patients with OSA and their bed partners will be contacted in their preferred manner (text messages, email, or phone call) periodically (no more than 4 per week) to determine how well they slept, to encourage them to use their CPAP, or to remind them to contact study staff if they are having difficulty using their CPAP.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: July 21, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)