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随机对照试验研究视听健康教育材料对 CPAP 依从性的影响:AHEAD 试验。

Randomized controlled trial on the efficacy of audio-visual health educational materials on CPAP adherence: the AHEAD trial.

机构信息

Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Brisbane, Australia.

Faculty of Medicine, University of Queensland, Brisbane, Australia.

出版信息

J Clin Sleep Med. 2022 Nov 1;18(11):2617-2625. doi: 10.5664/jcsm.10182.

DOI:10.5664/jcsm.10182
PMID:35924663
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9622984/
Abstract

STUDY OBJECTIVES

Educational interventions have been proposed to improve continuous positive airway pressure (CPAP) adherence; however, studies to date have not demonstrated robust effectiveness, due to methodological issues. Furthermore, these educational interventions have not specifically targeted low health literacy communication techniques, which have been demonstrated to improve outcomes in numerous other chronic diseases. We hypothesized that the addition of low-cost audio-visual educational videos (EVs) to usual standard-of-care (SC) education would improve CPAP adherence in adults with obstructive sleep apnea (OSA) syndrome.

METHODS

At CPAP initiation, treatment-naïve adults with OSA syndrome were randomized to (1) usual SC or (2) SC + 5 EVs showing a patient's journey, designed with low health literacy communication techniques to teach patients about OSA and CPAP therapy. The primary endpoint was CPAP usage at 2 months (hours/night) and secondary endpoints were CPAP usage at 12 months and percentage of patients with ≥ 4 hours/night use at 2 months and 12 months.

RESULTS

One hundred and ninety-five patients were randomized (SC 99, EV 96), with a mean age of 57 years (interquartile range [IQR] 44.1-64.8 years). There were no statistically significant differences in patient characteristics at baseline between the SC vs EV groups, with the diagnostic apnea-hypopnea index of 34 events/h (IQR 21-59 events/h) vs 30 events/h (IQR 20-50 events/h) and Epworth Sleepiness Scale score of 12.8 ± 6 vs 11.7 ± 5. At 2 months, there was no significant difference in hours of CPAP usage (SC: 3.45 hours/night [95% confidence interval (CI): 2.76 to 4.13] vs EV: 3.75 hours/night [95% CI: 3.14 to 4.37]) nor in proportion with adequate usage or overall commencement rate. However, at 12 months, there was a significant difference in hours of CPAP usage (SC: 2.50 hours/night [95% CI: 1.94 to 3.06] vs EV: 3.66 hours/night [95% CI: 2.92 to 4.40]). The probability of adequate CPAP usage at 12 months was higher in the intervention arm (odds ratio: 1.33; 95% CI: 1.04 to 1.7; = .013). Patients with low education backgrounds benefitted substantially from the EV intervention compared with SC (mean difference at 12 months = 2.47 hours/night usage; 95% CI: 1.01 to 2.93; < .01).

CONCLUSIONS

Low health literacy-designed EVs improve CPAP adherence at 12 months compared with SC, with the greatest impact in patients with a low educational background.

CLINICAL TRIAL REGISTRATION

Registry: Australian New Zealand Clinical Trials Registry; Name: Randomised controlled trial on the efficacy of audio-visual health educational materials on sleep health literacy and continuous positive airway pressure (CPAP) adherence in Sleep Clinic patients; URL: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000523101; Identifier: ACTRN12619000523101.

CITATION

Ellender CM, Samaranayake C, Reid N, et al. Randomized controlled trial on the efficacy of audio-visual health educational materials on CPAP adherence: the AHEAD trial. . 2022;18(11):2617-2625.

摘要

研究目的

已经提出了教育干预措施来提高持续气道正压通气(CPAP)的依从性;然而,迄今为止的研究由于方法学问题,并没有显示出强大的有效性。此外,这些教育干预措施并没有特别针对低健康素养沟通技巧,这些技巧已经在许多其他慢性疾病中证明可以改善结局。我们假设,在标准护理(SC)教育的基础上增加低成本的视听教育视频(EV),可以改善阻塞性睡眠呼吸暂停(OSA)综合征患者的 CPAP 依从性。

方法

在 CPAP 起始时,未经治疗的 OSA 综合征成年患者被随机分为(1)常规 SC 或(2)SC+5 个 EV,展示患者的旅程,设计采用低健康素养沟通技巧,向患者传授 OSA 和 CPAP 治疗知识。主要终点是 2 个月时的 CPAP 使用时间(小时/夜),次要终点是 12 个月时的 CPAP 使用时间和 2 个月和 12 个月时≥4 小时/夜使用的患者比例。

结果

195 名患者被随机分组(SC 99 名,EV 96 名),平均年龄为 57 岁(四分位间距[IQR] 44.1-64.8 岁)。在基线时,SC 组和 EV 组患者的特征没有统计学上的显著差异,诊断性呼吸暂停低通气指数为 34 次/小时(IQR 21-59 次/小时)和 30 次/小时(IQR 20-50 次/小时),嗜睡量表评分为 12.8±6 分和 11.7±5 分。在 2 个月时,CPAP 使用时间(SC:3.45 小时/夜[95%置信区间(CI):2.76 至 4.13]与 EV:3.75 小时/夜[95%CI:3.14 至 4.37])和足够使用或总体开始率的比例均无显著差异。然而,在 12 个月时,CPAP 使用时间有显著差异(SC:2.50 小时/夜[95%CI:1.94 至 3.06]与 EV:3.66 小时/夜[95%CI:2.92 至 4.40])。干预组的 CPAP 充分使用的概率更高(优势比:1.33;95%CI:1.04 至 1.7; =.013)。与 SC 相比,教育背景较低的患者从 EV 干预中获益显著(12 个月时的平均差异=2.47 小时/夜使用;95%CI:1.01 至 2.93; <.01)。

结论

与 SC 相比,采用低健康素养设计的 EV 可提高 12 个月时的 CPAP 依从性,对教育背景较低的患者影响最大。

临床试验注册

澳大利亚新西兰临床试验注册处;名称:关于视听健康教育材料对睡眠健康素养和 CPAP 依从性影响的随机对照试验;网址:https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000523101;标识符:ACTRN12619000523101。

引文

Ellender CM, Samaranayake C, Reid N, et al. 随机对照试验关于视听健康教育材料对 CPAP 依从性的影响:AHEAD 试验。. 2022;18(11):2617-2625.

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