Improving Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With An Intervention Based On Stratification and Personalization of Care Plans: A Randomized Controlled Trial

Abstract

Purpose The aim was to determine adherence to CPAP and health-related outcomes in patients with OSA via a comprehensive program based on stratification and individualized care plans, including motivational interview. Methods A multicentre, randomized controlled trial (RCT) design was used in 3 hospitals. The control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care plan (home visits, telephone, care-center) depending on socio-demographic, clinical and psychological variables, using motivational interviews in all the interventions. The main outcome was adherence, and secondary were quality of life, emotional state, activities, social relationships, perceived competence, and motivation. The clinical trial was registered with www.clinicaltrials.gov (NCT 04691479). Results 213 patients (68.1% men, 58.7% between 51–69 years old, 45.5% upper-secondary school education) were randomized: 108 were in the intervention group and 105 were in the control group. The result showed a statistically significant difference in adherence at 90 and 180 days respectively: 129.24 (IC 95% 77.25-181.22) p < 0.0001 and 288.30 (IC95% 187.146–389.47) p < 0.0001. The adherence (hours/day) showed favourable results for the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18–2.30) p < 0.0001 and at 180 days with a difference of 2.31 (IC95% 1.72–2.91) p < 0.001. The results for secondary outcomes also showed statistically significant differences in favour of the PIMA group. Conclusions This study found evidence that a program based on stratification and personalized care plans, through motivational interviewing, improves adherence to CPAP treatment and health-related outcomes than traditional care.

Study protocol of a randomized controlled trial of motivational interviewing-based intervention to improve adherence to continuous positive airway pressure in patients with obstructive sleep apnea syndrome: The MotivAir study

“…The results are patients with the “a” profile (characterized by autonomy and mobility, predisposition to remote-controlled follow-up), patients with the “b” profile (need for more intensity in follow-up), or patients with the “c” profile (more difficulties to move around and require more intensive treatment). Profile “d” was applied to patients who were professional drivers, as they require specific interventions based on their occupation (see Rudilla et al, 2021b ).…”

“…A sample of 80 patients (40 in each group) will allow detection as a significant effect size of 0.67 (based on the average daily difference in apnea hours between groups) measured at the 6-month follow-up, a first type error of 0.05, a power of 80% and a drop-out of 10%. Data related to the effect size were retrieved from the PIMA study ( Rudilla et al, 2021b ), while the mean daily difference in apnea hours and the standard deviation were provided by the researchers. The sample size was assessed using PASS 14 software (Power Analysis and Sample Size Software (2015).…”

“…A personalized-based intervention represents a golden standard for the cost-effective impact, but only one study has been achieved with personalization of care for patients with OSAS using CPAP. Rudilla et al (2021b) already showed increased compliance with the device, as well as increased self-efficacy, and quality of life in terms of daily activities, and social relationships in CPAP-naive patients with severe OSAS after receiving a personalized motivational intervention plan. The purpose of this randomized controlled trial (RCT) will be to determine whether MI-based strategies delivered by a nurse, and added to a standard pulmonary rehabilitation program, will be superior to usual care in improving adherence to CPAP.…”