Mechanisms of action of a web-based intervention with health professional support to increase nebulizer adherence in adults with Cystic Fibrosis: a qualitative interview study (Preprint)

BACKGROUND Adherence to nebulizer treatments in adults with cystic fibrosis is often low. A new complex intervention to help adults with cystic fibrosis increase adherence to nebulizer treatments was tested in a pilot randomized controlled trial in two UK cystic fibrosis centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time, and a tailored website to display graphs of adherence data and educational and problem solving information about adherence. A trained interventionist helped patients to identify ways to increase their adherence. OBJECTIVE To explore the mechanisms of action of this complex intervention. METHODS A qualitative interview study undertaken concurrently with a pilot randomized controlled trial. 25 semi-structured interviews were conducted with three interventionists at two time points, 14 patients in the intervention arm of the trial, and five members of the multidisciplinary teams offering wider care to patients. A framework approach was used for analysis. RESULTS The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of Vassilev's mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals but there were challenges in how the intervention fitted into some patients' busy lives when delivered through a desktop computer. CONCLUSIONS Mechanisms associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example delivery through an app accessed via mobile phones, and then tested in a randomized controlled trial in 19 UK cystic fibrosis centers. CLINICALTRIAL Registration: ISRCTN 13076797.