The Improving Sleep in African American Couples (ISAAC) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 4
- 主要终点
- Mean Nightly CPAP Use at 1 Year
研究概览
简要总结
The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.
详细描述
This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in 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 cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe OSA (Apnea hypopnea index ≥ 15 events/hour)
- •Age ≥ 30 years
- •Bed partner for ≥ last 6 months who is willing to participate
- •English proficient
- •Inclusion Criteria - Bed Partner
- •Bed partner for ≥ 6 months and willing to participate
- •English proficient
排除标准
- •Terminal illness
- •Neurocognitive disorder that prevents informed consent
- •Unstable housing
- •Need for other forms of positive airway pressure (BPAP or VPAP)
- •Pregnancy
研究组 & 干预措施
Usual Care
Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
干预措施: CPAP Training and Education (Behavioral)
Usual Care
Patients will receive optimal standard of care in the management of OSA and will continue to meet with their health care providers per usual.
干预措施: Virtual Disease Support Group Sessions (Behavioral)
Couple-oriented Intervention Arm
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following
- CPAP instruction from sleep technologist
- 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner
- Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes
5. 5 cognitive behavioral couple therapy sessions
干预措施: Couple CPAP Training and Education (Behavioral)
Couple-oriented Intervention Arm
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following
- CPAP instruction from sleep technologist
- 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner
- Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes
5. 5 cognitive behavioral couple therapy sessions
干预措施: Couples Virtual OSA Support Group Sessions (Behavioral)
Couple-oriented Intervention Arm
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following
- CPAP instruction from sleep technologist
- 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner
- Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes
5. 5 cognitive behavioral couple therapy sessions
干预措施: CPAP Tele-monitoring and Feedback (Behavioral)
Couple-oriented Intervention Arm
Patients will participate in usual care by their sleep providers. Patients and their bed partners will receive the following
- CPAP instruction from sleep technologist
- 3 virtual group sessions with an African American patient who regularly uses CPAP and their bed partner
- Regular review of CPAP adherence with feedback to patient and bed partner when CPAP adherence changes
5. 5 cognitive behavioral couple therapy sessions
干预措施: Couples' Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Mean Nightly CPAP Use at 1 Year
时间窗: From enrollment until 1 year.
Mean CPAP use at year will be the total hours of CPAP use divided by the number of days observed for the patient over the course of a year.
次要结局
- Patient-Reported Measure of OSA Treatment(From enrollment to 30 days, 90 days, 6 months, and 1 year)
- Mean Nightly CPAP Use(From enrollment to 30 days, 90 days, and 6 months.)
- Patient and Bed Partner Quality of Sleep(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
- Patient and Bed Partner Quality of Sleep(6 months)
- Patient and Bed Partner Quality of Life(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
- Patient and Bed Partner Sleep Apnea Quality of Life(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
- Sleep Apnea Beliefs(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
- Sleep Apnea Knowledge(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
- Self-efficacy to Use CPAP(From enrollment to 30 days, 90 days, 6 months, and 1 year.)
研究者
Daryl Thornton, MD
Principal Investigator
MetroHealth Medical Center