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

STUDY

objectivesEducational 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.

methodsAt 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.

resultsOne 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;

conclusionsLow 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 registrationRegistry: 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.