In patients with cystic fibrosis (CF), the use of a self-management intervention involving data-logging nebulizers, a digital platform, and behavioral change sessions attained higher adherence rates than usual care. This was among the findings of research recently published in the journal Thorax.
Investigators in the United Kingdom conducted a 2-arm, parallel-group, open-label, randomized controlled trial at 19 CF centers to assess whether a self-management intervention designed to support treatment adherence would decrease exacerbation rates among patients with CF. From October 2017 through May 2018, 607 patients with CF aged 16 years or older were randomized to treatment via a multicomponent intervention (data-logging nebulizers, a digital platform, and behavioral change sessions with trained clinical interventionists; n = 304) or usual care (data-logging nebulizers; n = 303).
The primary study outcome was pulmonary exacerbations. Secondary endpoints included percent predicted forced expiratory volume in 1 second (FEV1), which was measured at each clinical encounter; BMI, which was calculated at baseline and at 12 months; and Cystic Fibrosis Questionnaire-Revised (CFQ-R) score, which measures quality of life and includes a perceived CF treatment burden subscale. Among all study participants, 88% completed the 12-month follow-up. The median participant age was 31 years; 51% of the patients were female. The median number of interventionist sessions per participant was 7.0 (range, 6.0 to 10.0).
Results of the study showed that the mean exacerbation rate was 1.63 per year in the intervention arm and 1.77 per year in the usual-care arm (adjusted ratio, 0.96; 95% CI, 0.83-1.12; P =.64), which was not statistically significant. Likewise, over 12 months, the percent predicted FEV1 decreased by 0.1 in the intervention arm (from 60.7±23.5 to 60.6±24.2) and by 1.4 (from 58.3±22.6 to 56.9±23.0) in the usual-care arm, which was not statistically significant.
With respect to objectively measured adherence, adjusted mean differences favored the intervention group compared with the usual-care group (mean difference, 9.5%; 95% CI, 8.6%-10.4%). Adjusted mean differences in BMI also favored the intervention group vs the usual-care group (mean difference, 0.3 kg/m2; 95% CI, 0.1-0.6 kg/m2).
With respect to CFQ-R scores, although 7 of 8 different CFQ-R subscales revealed no between-group differences, the CF treatment burden subscale scores were reduced in the intervention group (by 3.9 points; 95% CI, 1.2-6.7 points). Among the other 11-patient-reported outcomes at 12 months, which included 2 safety measures, 6 demonstrated differences with the intervention vs usual care.
The researchers noted that to date, the current trial is the only study to report a sustained difference in adherence with the use of a theory-based intervention approach that includes habit formation. Because adherence is low among patients with long-term conditions such as CF and because prescribed medications work only if taken appropriately, further exploration of adherence interventions is critical.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Wildman MJ, O’Cathain A, Maguire C, et al; CFHealthHub Study Team. Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial. Thorax. Published online September 23, 2021. doi:10.1136/thoraxjnl-2021-217594