CPAP Adherence Pilot Study Among African Americans

Sponsor

MetroHealth Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05955287

Collaborator

(none)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Behavioral: Telemonitoring Behavioral: Peer Based Behavioral: CPAP Education Behavioral: Usual Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Couple Intervention 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 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. Behavioral: Peer Based 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. Behavioral: CPAP Education 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 Behavioral: Usual Care Participants will receive OSA education and CPAP training from providers trained in OSA management.
Active Comparator: Control 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 Participants will receive OSA education and CPAP training from providers trained in OSA management.

Arm

Intervention/Treatment

Experimental: Couple Intervention

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

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.

Behavioral: Peer Based

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.

Behavioral: CPAP Education

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

Behavioral: Usual Care

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

Active Comparator: Control

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

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

Outcome Measures

Primary Outcome Measures

CPAP Adherence [3 months]
Mean hours per night of CPAP use

Secondary Outcome Measures

Sleep Apnea Quality of Life [3 months]
Calgary Sleep Apnea Quality of Life Index. 84 items with higher scores suggesting higher quality of life
Patient and Partner Sleepiness [3 months]
Epworth Sleepiness Scale (ESS) - 8 items, with scoring range 0 - 24. Higher scores are associated with increased sleepiness.
Patient and Partner Quality of Sleep [3 months]
Functional Outcomes of Sleep Questionnaire (FOSQ-10) Patient and Partner Functional Status assessed in 10 questions with lower scores suggesting worse outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MetroHealth Medical System	Cleveland	Ohio	United States	44109

Sponsors and Collaborators

MetroHealth Medical Center

Investigators

Principal Investigator: John D Thornton, MD, MPH, MetroHealth System

Study Documents (Full-Text)

Study Protocol - Jul 22, 2022

More Information

Publications

None provided.

Responsible Party:

Daryl Thornton, MD, 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, MetroHealth Medical Center

ClinicalTrials.gov Identifier:

NCT05955287

Other Study ID Numbers:

STUDY00000055

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Daryl Thornton, MD, 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, MetroHealth Medical Center

obstructive sleep apnea

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Study Results

No Results Posted as of Jul 21, 2023