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CPAP Adherence Pilot Study Among African Americans

Primary Purpose

Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemonitoring
Peer Based
CPAP Education
Usual Care
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring obstructive sleep apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • MetroHealth Medical SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Couple Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

CPAP Adherence
Mean hours per night of CPAP use

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2023
Last Updated
July 12, 2023
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05955287
Brief Title
CPAP Adherence Pilot Study Among African Americans
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Couple Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Telemonitoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Based
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CPAP Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will receive OSA education and CPAP training from providers trained in OSA management.
Primary Outcome Measure Information:
Title
CPAP Adherence
Description
Mean hours per night of CPAP use
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep Apnea Quality of Life
Description
Calgary Sleep Apnea Quality of Life Index. 84 items with higher scores suggesting higher quality of life
Time Frame
3 months
Title
Patient and Partner Sleepiness
Description
Epworth Sleepiness Scale (ESS) - 8 items, with scoring range 0 - 24. Higher scores are associated with increased sleepiness.
Time Frame
3 months
Title
Patient and Partner Quality of Sleep
Description
Functional Outcomes of Sleep Questionnaire (FOSQ-10) Patient and Partner Functional Status assessed in 10 questions with lower scores suggesting worse outcomes
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John D Thornton, MD,MPH
Phone
216-778-3732
Email
dthornton@metrohealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Thornton, MD, MPH
Organizational Affiliation
MetroHealth System
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John D Thornton, MD, MPH
Phone
216-778-3732
Email
dthornton@metrohealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results from the study will be shared through the publication of findings in research journals and via presentation at scientific meetings. Results will be directly shared with participants upon inquiry.

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CPAP Adherence Pilot Study Among African Americans

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