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      Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study

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          Abstract

          Background

          Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence.

          Objective

          This study aims to explore the mechanisms of action underpinning the intervention.

          Methods

          A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the 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 additional 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

          The mechanisms of action 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 an RCT in 19 UK CF centers.

          Trial Registration

          International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797

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          Most cited references46

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          The behaviour change wheel: A new method for characterising and designing behaviour change interventions

          Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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            Process evaluation of complex interventions: Medical Research Council guidance

            Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
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              Validation of the theoretical domains framework for use in behaviour change and implementation research

              Background An integrative theoretical framework, developed for cross-disciplinary implementation and other behaviour change research, has been applied across a wide range of clinical situations. This study tests the validity of this framework. Methods Validity was investigated by behavioural experts sorting 112 unique theoretical constructs using closed and open sort tasks. The extent of replication was tested by Discriminant Content Validation and Fuzzy Cluster Analysis. Results There was good support for a refinement of the framework comprising 14 domains of theoretical constructs (average silhouette value 0.29): ‘Knowledge’, ‘Skills’, ‘Social/Professional Role and Identity’, ‘Beliefs about Capabilities’, ‘Optimism’, ‘Beliefs about Consequences’, ‘Reinforcement’, ‘Intentions’, ‘Goals’, ‘Memory, Attention and Decision Processes’, ‘Environmental Context and Resources’, ‘Social Influences’, ‘Emotions’, and ‘Behavioural Regulation’. Conclusions The refined Theoretical Domains Framework has a strengthened empirical base and provides a method for theoretically assessing implementation problems, as well as professional and other health-related behaviours as a basis for intervention development.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J Med Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                October 2020
                6 October 2020
                : 22
                : 10
                : e16782
                Affiliations
                [1 ] School of Health and Related Research University of Sheffield Sheffield United Kingdom
                [2 ] Centre for Behavioural Science and Applied Psychology Sheffield Hallam University Sheffield United Kingdom
                [3 ] Sheffield Adult CF Centre Sheffield Teaching Hospitals Sheffield United Kingdom
                Author notes
                Corresponding Author: Sarah J Drabble s.j.drabble@ 123456sheffield.ac.uk
                Author information
                https://orcid.org/0000-0001-7183-6321
                https://orcid.org/0000-0003-4033-506X
                https://orcid.org/0000-0001-7426-7099
                https://orcid.org/0000-0002-6199-717X
                https://orcid.org/0000-0003-3685-2849
                https://orcid.org/0000-0002-4710-657X
                https://orcid.org/0000-0002-9397-7608
                https://orcid.org/0000-0002-1658-881X
                Article
                v22i10e16782
                10.2196/16782
                7576463
                32697197
                51f5e838-821e-40a5-a1cb-b420773a5530
                ©Sarah J Drabble, Alicia O'Cathain, Alexander J Scott, Madelynne A Arden, Samuel Keating, Marlene Hutchings, Chin Maguire, Martin Wildman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.10.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 24 October 2019
                : 23 December 2019
                : 14 May 2020
                : 25 June 2020
                Categories
                Original Paper
                Original Paper

                Medicine
                united kingdom,cystic fibrosis,adherence,compliance,health behavior,psychological theory,process evaluation,qualitative research,interview,patient portals,telehealth

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