COMMENCE Study: COMMunication and Education for the New CPAP Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Daytime Sleepiness
研究概览
简要总结
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
详细描述
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is 21 years of age and older
- •Have spouse or partner
- •Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
- •Choice of continuous positive airway pressure (CPAP) as preferred treatment
- •Age is 18 years of age and older
- •Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment
排除标准
- •AHI < 5 on the diagnostic PSG
- •Have a spouse or partner with OSA diagnosis and on OSA treatment
- •Past treatment for OSA
- •Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
- •Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
- •History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner:
- •Have been diagnosed with OSA and using CPAP
研究组 & 干预措施
Patients in the Couple-oriented intervention
Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session.
干预措施: Couple-oriented intervention (Behavioral)
Patients in the Couple-oriented intervention
Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session.
干预措施: Continuous positive airway pressure (CPAP) (Device)
Patients in Usual Care
Patients will not attend any intervention sessions.
干预措施: Continuous positive airway pressure (CPAP) (Device)
Patients in the Patient-oriented intervention
Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.
干预措施: Patient-oriented intervention (Behavioral)
Patients in the Patient-oriented intervention
Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.
干预措施: Continuous positive airway pressure (CPAP) (Device)
Partners in the Couple-oriented intervention
Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
干预措施: Couple-oriented intervention (Behavioral)
Partners in the Patient-oriented intervention
Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
干预措施: Patient-oriented intervention (Behavioral)
Partners in Usual Care
Partners will not attend any intervention sessions.
干预措施: No intervention (Other)
结局指标
主要结局
Daytime Sleepiness
时间窗: baseline and 3 months after CPAP initiation
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness.
Sleep Quality
时间窗: baseline and 3 months after CPAP initiation
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score \> 5 indicates a poor sleeper.
Sleep-related Functional Outcomes
时间窗: baseline and 3 months after CPAP initiation
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.
次要结局
- Continuous Positive Airway Pressure (CPAP) Adherence(one week, one month, and 3 months after CPAP initiation)
研究者
Faith Luyster
Assistant Professor
University of Pittsburgh