scholarly journals Development of an intervention to increase adherence to nebuliser treatment in adults with Cystic Fibrosis: CFHealthHub

2020 ◽  
Author(s):  
Madelynne Arden ◽  
Marlene Hutchings ◽  
Pauline Whelan ◽  
Sarah J. Drabble ◽  
Daniel Beever ◽  
...  
Keyword(s):  
Development Strategy ◽  
Treatment Adherence ◽  
Behaviour Change ◽  
Multidisciplinary Team ◽  
Treatment Plan ◽  
Controlled Trial ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques ◽  
Randomised Controlled

BackgroundCystic Fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden.MethodsIntervention development was informed by the behaviour change wheel (BCW) and Person-Based Approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions, and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. ResultsResults indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback, confidence in their ability to adhere, to have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs.ConclusionsThe intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

scholarly journals Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
M. A. Arden ◽  
M. Hutchings ◽  
P. Whelan ◽  
S. J. Drabble ◽  
D. Beever ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Development Strategy ◽  
Treatment Adherence ◽  
Behaviour Change ◽  
Multidisciplinary Team ◽  
Treatment Plan ◽  
Controlled Trial ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques

Abstract Background Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

scholarly journals Developing a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice and subsequently change antibiotic use

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e035793 ◽  
Author(s):  
Marta Santillo ◽  
Marta Wanat ◽  
Mina Davoudianfar ◽  
Emily Bongard ◽  
Sinisa Savic ◽  
...  
Keyword(s):  
General Practice ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Intervention Development ◽  
Penicillin Allergy ◽  
Feasibility Trial ◽  
Rapid Review ◽  
Behavioural Intervention ◽  
Behaviour Change Techniques ◽  
Intervention Package

ObjectivesTo develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result.MethodsTheory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention ‘guiding principles’ and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials.ResultsThe collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers.ConclusionsWe present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.

scholarly journals Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeremy Horwood ◽  
Melanie Chalder ◽  
Ben Ainsworth ◽  
James Denison-Day ◽  
Frank de Vocht ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Behaviour Change Techniques ◽  
Current Standard ◽  
Link Type ◽  
Implementation Period ◽  
Full Protocol ◽  
Randomised Controlled

Abstract Objectives To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. Trial design A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. Participants Setting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices. Intervention and comparator Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website (http://GermDefence.org/) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users’ personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. Main outcomes The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice Randomisation GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. Blinding (masking) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. Numbers to be randomised (sample size) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. Trial status Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. Trial registration This trial was registered in the ISRCTN registry (isrctn.com/ISRCTN14602359) on 12 August 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Leon ◽  
Hazel Namadingo ◽  
Kirsty Bobrow ◽  
Sara Cooper ◽  
Amelia Crampin ◽  
...  
Keyword(s):  
Treatment Adherence ◽  
Controlled Trial ◽  
Text Message ◽  
Intervention Development ◽  
Text Messages ◽  
Sub Saharan Africa ◽  
Diabetes Treatment ◽  
Sub Saharan ◽  
Randomised Controlled

Abstract Background Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process. Method We describe and reflect on the process of designing and pretesting an evidence- and theory-informed brief messaging intervention, to improve diabetes treatment adherence in sub-Saharan Africa. We followed the stepwise approach recommended by the Medical Research Council, United Kingdom (MRC UK) Framework for Development and Evaluation of Complex Health Interventions and guidance for mobile health intervention development. Results We used a four-phase, iterative approach that first generated primary and secondary evidence on the lived experience of diabetes, diabetes treatment services and mobile-phone use. Second, we designed a type 2 diabetes-specific, brief text-message library, building on our previous hypertension text-message library, as well as drawing on the primary and secondary data from phase one, and on expert opinion. We then mapped the brief text-messages onto behaviour change (COM-B) theoretical constructs. Third, we refined and finalised the newly developed brief text-message library through stakeholder consultation and translated it into three local languages. Finally, we piloted the intervention by pre-testing the automated delivery of the brief text-messages in the trial sites in Malawi and South Africa. The final SMS text Adherence suppoRt for people with type 2 diabetes (StAR2D) intervention was tested in a randomised controlled trial in Malawi and South Africa (trial registration: ISRCTN70768808). Conclusion The complexity of public health interventions requires that we give more attention to intervention development work. Our documentation and reflection on the StAR2D intervention development process promotes transparency, replicability, assessment of intervention quality, and comparison with other studies.

scholarly journals Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be)

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053711
Author(s):  
Lili L Kókai ◽  
Diarmaid T Ó Ceallaigh ◽  
Anne I Wijtzes ◽  
Jeanine E Roeters van Lennep ◽  
Martin S Hagger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Well Being ◽  
Behaviour Change Techniques ◽  
Automatic Processes ◽  
Post Intervention ◽  
Randomised Controlled

IntroductionEfficacy tests of physical activity interventions indicate that many have limited or short-term efficacy, principally because they do not sufficiently build on theory-based processes that determine behaviour. The current study aims to address this limitation.Methods and analysisThe efficacy of the 8-week intervention will be tested using a three-condition randomised controlled trial delivered through an app, in women with a prior hypertensive pregnancy disorder. The intervention is based on the integrated behaviour change model, which outlines the motivational, volitional and automatic processes that lead to physical activity. The mechanisms by which the behaviour change techniques lead to physical activity will be tested.Following stratification on baseline factors, participants will be randomly allocated in-app to one of three conditions (1:1:1). The information condition will receive information, replicating usual care. Additionally to what the information condition receives, the motivation condition will receive content targeting motivational processes. Additionally to what the motivation condition receives, the action condition will receive content targeting volitional and automatic processes.The primary outcome is weekly minutes of moderate-to-vigorous physical activity, as measured by an activity tracker (Fitbit Inspire 2). Secondary outcomes include weekly average of Fitbit-measured daily resting heart rate, and self-reported body mass index, waist-hip ratio, cardiorespiratory fitness and subjective well-being. Tertiary outcomes include self-reported variables representing motivational, volitional, and automatic processes. Outcome measures will be assessed at baseline, immediately post-intervention, and at 3 and 12 months post-intervention. Physical activity will also be investigated at intervention midpoint. Efficacy will be determined by available case analysis. A process evaluation will be performed based on programme fidelity and acceptability measures.Ethics and disseminationThe Medical Ethics Committee of the Erasmus MC has approved this study (MEC-2020-0981). Results will be published in peer reviewed scientific journals and presented at scientific conferences.Trial registration numberNetherlands trial register, NL9329.

scholarly journals Do combinations of behaviour change techniques that occur frequently in interventions reflect underlying theory?

2019 ◽  
Author(s):  
Lauren Connell Bohlen ◽  
Susan Michie ◽  
Marijn de Bruin ◽  
Alexander Rothman ◽  
Michael P Kelly ◽  
...  
Keyword(s):  
Factor Analysis ◽  
Behaviour Change ◽  
Change Theory ◽  
Intervention Development ◽  
Evidence Base ◽  
Behaviour Change Techniques ◽  
Behavioural Interventions ◽  
Behavioral Theories ◽  
Theory Use ◽  
Selection Of

Background: Behavioural interventions typically include multiple behaviour change techniques (BCTs). The theory informing the selection of BCTs for an intervention may be stated explicitly, or remain unreported, thus impeding the identification of links between theory and behaviour change outcomes. Purpose: This study aimed to identify groups of BCTs commonly occurring together in behaviour change interventions and examine whether behaviour change theories underlying these groups could be identified.Methods: The study involved three phases: 1) a factor analysis to identify groups of co-occurring BCTs from 277 behaviour change intervention reports; 2) an expert consensus exercise (n=25) to examine links between BCT groups and behavioral theories; 3) a comparison of the expert-linked theories with theories explicitly mentioned by authors of the 277 intervention reports.Results: Five groups of co-occurring BCTs (range: 3-13 BCTs per group) were identified through factor analysis. Experts agreed on five links (≥80% of experts), comprising three BCT groups and five behaviour change theories. Four of the five BCT Group-theory links agreed by experts were also stated by study authors in intervention reports using similar groups of BCTs.Conclusions: It is possible to identify groups of BCTs frequently used together in interventions. Experts made shared inferences about behaviour change theory underlying these BCT groups, suggesting it may be possible to propose a theoretical basis for interventions where authors do not explicitly put forward a theory. These results advance our understanding of theory use in multi-component interventions and build the evidence base for further understanding theory-based intervention development and evaluation.

scholarly journals Clinically, what ought we to believe?

2018 ◽  
Vol 27 (1) ◽  
pp. 72-74 ◽  
Author(s):  
John D Little ◽  
Lorraine Davison ◽  
Robert D Little
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relevant Information ◽  
Evidence Base ◽  
Social Interventions ◽  
Hierarchy Of Evidence ◽  
Differences Of Opinion ◽  
The Status ◽  
Randomised Controlled ◽  
Clinical Strategy

Objective: To question the status of the randomised controlled trial (RCT) in the hierarchy of evidence. Conclusions: The RCT provides important and clinically relevant information, particularly in psychopharmacology. However, and as with other methodologies, RCTs too are flawed and automatic abdication to their conclusions, especially in complex social interventions, is unwise. A clinical example with conflicting and polarising views, each with their evidence base, is described alongside a suggested clinical strategy for resolving differences of opinion.

scholarly journals Analysis of the components of cancer risk perception and links with intention and behaviour: A UK-based study

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262197
Author(s):  
Christiane Riedinger ◽  
Jackie Campbell ◽  
William M. P. Klein ◽  
Rebecca A. Ferrer ◽  
Juliet A. Usher-Smith
Keyword(s):  
Factor Analysis ◽  
Risk Perception ◽  
Cancer Risk ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Distinct Component ◽  
Cancer Risk Perception ◽  
Before And After ◽  
Randomised Controlled ◽  
The Uk

Risk perception refers to how individuals interpret their susceptibility to threats, and has been hypothesised as an important predictor of intentions and behaviour in many theories of health behaviour change. However, its components, optimal measurement, and effects are not yet fully understood. The TRIRISK model, developed in the US, conceptualises risk perception as deliberative, affective and experiential components. In this study, we aimed to assess the replicability of the TRIRISK model in a UK sample by confirmatory factor analysis (CFA), explore the inherent factor structure of risk perception in the UK sample by exploratory factor analysis (EFA), and assess the associations of EFA-based factors with intentions to change behaviour and subsequent behaviour change. Data were derived from an online randomised controlled trial assessing cancer risk perception using the TRIRISK instrument and intention and lifestyle measures before and after communication of cancer risk. In the CFA analysis, the TRIRISK model of risk perception did not provide a good fit for the UK data. A revised model developed using EFA consisted of two separate “numerical” and “self-reflective” factors of deliberative risk perception, and a third factor combining affective with a subset of experiential items. This model provided a better fit to the data when cross-validated. Using multivariable regression analysis, we found that the self-reflective and affective-experiential factors of the model identified in this study were reliable predictors of intentions to prevent cancer. There were no associations of any of the risk perception factors with behaviour change. This study confirms that risk perception is clearly a multidimensional construct, having identified self-reflective risk perception as a new distinct component with predictive validity for intention. Furthermore, we highlight the practical implications of our findings for the design of interventions incorporating risk perception aimed at behaviour change in the context of cancer prevention.

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