Berry Richard B, Beck Emily, Jasko Jeffrey G
Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida.
Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, Florida.
J Clin Sleep Med. 2020 Apr 15;16(4):553-562. doi: 10.5664/jcsm.8276.
Decreased early positive airway pressure (PAP) adherence is predictive of poor long-term adherence. We hypothesized that cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact with patients starting treatment would improve early adherence.
At PAP set-up patients were randomized to: (1) standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC. Primary 3-month endpoints were adherence (all nights, nights used, % of nights ≥ 4 hours use, and % participants with ≥ 4 hours use on ≥ 70% of nights [% ≥ 4 ≥ 70%]) and secondary endpoints were change in Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use.
Two hundred fifty participants were randomized (SC 126, SC+CBSC 124). Characteristics SC versus SC+CBSC (mean ± SD) for age (55.2 ± 13.4 versus 54.9 ± 11.5 years), diagnostic apnea-hypopnea index (36.7 ± 21.1 versus 36.6 ± 20.6 events/h), and ESS (10.8 ± 6.1 versus 11.2 ± 6.0) did not differ. At 3 months, the % of days with ≥ 4 hours of PAP use (SC: 48.1 ± 36.8% versus SC+CBSC: 57.9 ± 35.4%, P = 0.032), use all nights (SC:3.7 ± 2.7 hours versus SC + CBSC: 4.4 ± 2.6 hours, P=0.027), and PAPapp use satisfaction were greater with SC+CBSC (intention to treat analysis). The [% ≥ 4 ≥ 70%] did not differ between groups in the intention to treat analysis but was higher in those completing CBSC interventions. The ESS improvement and patient satisfaction did not differ between groups.
The CBSC system improved PAP adherence at 3 months.
Registry: ClinicalTrials.gov; Title: ThErapy Adherence Management in Veterans; Identifier: NCT03243487; URL: https://clinicaltrials.gov/ct2/show/NCT03243487.
早期持续气道正压通气(PAP)依从性降低预示着长期依从性差。我们假设基于云的睡眠指导(CBSC)通过提供协议驱动的实时电话联系,帮助开始治疗的患者,能够提高早期依从性。
在PAP设置时,患者被随机分为:(1)标准护理(SC),包括呼吸治疗师进行PAP设置、无线依从性监测以及选择性使用移动依从性反馈应用程序(PAPapp);或(2)SC+CBSC。3个月的主要终点是依从性(所有夜晚、使用的夜晚、≥4小时使用的夜晚百分比以及≥70%的夜晚有≥4小时使用的参与者百分比[≥4≥70%]),次要终点是Epworth嗜睡量表(ESS)的变化以及对治疗和PAPapp使用的满意度。
250名参与者被随机分组(SC组126人,SC+CBSC组124人)。SC组与SC+CBSC组在年龄(55.2±13.4岁对54.9±11.5岁)、诊断性呼吸暂停低通气指数(36.7±21.1次/小时对36.6±20.6次/小时)和ESS(10.8±6.1对11.2±6.0)方面的特征无差异。3个月时,SC+CBSC组在≥4小时使用PAP的天数百分比(SC组:48.1±36.8%对SC+CBSC组:57.9±35.4%,P=0.032)、整夜使用时间(SC组:3.7±2.7小时对SC+CBSC组:4.4±2.6小时,P=0.027)以及对PAPapp使用的满意度方面更高(意向性分析)。在意向性分析中,两组间的[≥4≥70%]无差异,但在完成CBSC干预的患者中更高。两组间的ESS改善情况和患者满意度无差异。
CBSC系统在3个月时提高了PAP依从性。
注册机构:ClinicalTrials.gov;标题:退伍军人的治疗依从性管理;标识符:NCT03243487;网址:https://clinicaltrials.gov/ct2/show/NCT03243487 。