Self-management intervention supports treatment adherence in adults with cystic fibrosis

A self-management intervention aided adults with cystic fibrosis in achieving greater adherence to inhaled medications, habit strength, lower perceived treatment burden and higher BMI over 12 months compared with usual care.

However, results demonstrated no significant difference in exacerbations or FEV1 between the intervention and usual care.

“When it comes to thinking about adherence to nebulizers, there are literature out now using date- and time-stamp data to give us some kind of idea of how much treatment people actually take,” Martin J. Wildman, MRCP, MSc, PhD, honorary senior clinical lecturer and consultant in respiratory medicine and adult cystic fibrosis at the University of Sheffield Teaching Hospital, U.K., said during a presentation at the virtual North American Cystic Fibrosis Conference. “It looks like untreated adherence for nebulized therapy in adults is about 30%.”

Wildman and colleagues with the CFHealthHub Study Team developed a self-management intervention, which he described as underpinned by behavioral science therapy and with input from patients with cystic fibrosis to improve adherence to inhaled medications. The current study aimed to evaluate effectiveness of the intervention compared with usual care.

The 12-month, two-arm parallel group, open-label, randomized controlled trial included 608 adults with cystic fibrosis at 19 centers recruited from October 2017 to May 2018. Patients were randomly assigned to data-logging nebulizers plus the CFHealthHub digital platform to promote tailored digital content and manual behavior-change sessions that were delivered by trained clinicians, with intervention components including data feedback, motivation, barrier resolution and habit formation (n = 305; mean age, 28.9 years; 51.3% women) or usual care including data-logging nebulizers (n = 303; mean age, 27.7 years; 50.8% women).

The primary outcome was exacerbation and secondary outcomes included adherence, habit strength, BMI and FEV1.

At 52 weeks, the level of adherence in the intervention group improved to about 52.9% with an adjusted mean difference of 9.5% and an absolute difference of 18% compared with the usual-care group, which reverting back to baseline adherence of 35%.

Researchers observed no significant difference in exacerbations between the intervention and the usual-care group (adjusted incidence RR = 0.96; 95% CI, 0.83-1.12) or FEV₁ (adjusted mean difference = 1.4; 95% CI, –0.2 to 3).

BMI slightly increased (adjusted mean difference = 0.3; 95% CI, 0.1-0.6), habit strength significantly increased (adjusted mean difference = 1.2; 95% CI, 0.5-1.8) and Cystic Fibrosis Questionnaire Revised (CFQ-R) treatment burden significantly declined (adjusted mean difference = 3.9; 95% CI, 1.2-6.7).

There was a decrease in concerns about medication (adjusted mean difference = –0.2; 95% CI, –0.2 to –0.1) and an increase in necessity about medication (adjusted mean difference = 0.1; 95% CI, 0-0.2).

“By feeding back data to these people and supporting their adherence, the good news was the relationship shielded them from the challenge of working on their adherence and there was no difference in anxiety and depression,” Wildman said. “Possibly somewhat disappointingly, there was no difference in exacerbations or lung function.”

Wildman noted that ascertainment bias, the fact that the study was underpowered to detect a difference in FEV₁ and overrecruitment of high adherers may have played a role in the results.