A Pilot Study to Determine the Feasibility of a Couples' Oriented Intervention to Promote CPAP Adherence Among African American Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CPAP Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have same bed partner(s) for at least 6 months.
- •Must be at least 18 years of age
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Usual Care (Behavioral)
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.
干预措施: Telemonitoring (Behavioral)
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.
干预措施: Peer Based (Behavioral)
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.
干预措施: CPAP Education (Behavioral)
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.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
CPAP Adherence
时间窗: 3 months
Mean hours per night of CPAP use
次要结局
- Patient and Partner Sleepiness(3 months)
- Sleep Apnea Quality of Life(3 months)
- Patient and Partner Quality of Sleep(3 months)
研究者
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