Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform.

BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

A Digital Intervention for Respiratory Tract Infections (Internet Dr): Process Evaluation to Understand How to Support Self-care for Minor Ailments.

BACKGROUND: Approximately 57 million physician appointments annually in the United Kingdom are for minor ailments. These illnesses could be self-cared for, which would potentially lower patients' anxiety, increase their confidence, and be more convenient. In a randomized controlled trial of the Internet Dr digital intervention, patients with access to the intervention had fewer consultations for respiratory tract infections (RTIs). Having established intervention efficacy, further examination of trial data is required to understand how the intervention works. OBJECTIVE: This paper reports a process evaluation of Internet Dr usage by the intervention group. The evaluation aims to demonstrate how meaningful usage metrics (ie, interactions that are specific and relevant to the intervention) can be derived from the theoretical principles underlying the intervention, then applied to examine whether these interactions are effective in supporting self-care for RTIs, for whom, and at what time. METHODS: The Internet Dr trial recorded patients' characteristics and usage data over 24 weeks. At follow-up, users reported whether their levels of enablement to cope with their illness changed over the trial period. The Medical Research Council process evaluation guidance and checklists from the framework for Analyzing and Measuring Usage and Engagement Data were applied to structure research questions examining associations between usage and enablement. RESULTS: Viewing pages containing advice on caring for RTIs were identified as a meaningful metric for measuring intervention usage. Almost half of the users (616/1491, 42.31%) viewed at least one advice page, with most people (478/616, 77.6%) accessing them when they initially enrolled in the study. Users who viewed an advice page reported increased enablement to cope with their illness as a result of having participated in the study compared with users who did not (mean 2.12, SD 2.92 vs mean 1.65, SD 3.10; mean difference 0.469, 95% CI 0.082-0.856). The target population was users who had visited their general practitioners for an RTI in the year before the trial, and analyses revealed that this group was more likely to access advice pages (odds ratio 1.35, 95% CI 1.159-1.571; P<.001). CONCLUSIONS: The process evaluation identifies viewing advice pages as associated with increased enablement to self-care, even when accessed in the absence of a RTI, meaning that dissemination activities need not be restricted to targeting users who are ill. The intervention was effective at reaching the target population of users who had previously consulted their general practitioners. However, attrition before reaching advice pages was high, highlighting the necessity of prioritizing access during the design phase. These findings provide guidance on how the intervention may be improved and disseminated and have wider implications for minor ailment interventions.

Infection control in the home: a qualitative study exploring perceptions and experiences of adhering to protective behaviours in the home during the COVID-19 pandemic.

OBJECTIVES: We sought to explore people's experiences and perceptions of implementing infection control behaviours in the home during the COVID-19 pandemic, guided by an online behavioural intervention. DESIGN: Inductive qualitative study. SETTING: UK public during the COVID-19 pandemic. PARTICIPANTS: Thirteen people took part in telephone interviews, and 124 completed a qualitative open-text survey. All were recruited from the public. Most survey participants were aged over 60 years, while interview participants were more distributed in age. Most reported being at increased risk from COVID-19, and were white British. INTERVENTION: Online behavioural intervention to support infection control behaviours in the home during the COVID-19 pandemic. DATA COLLECTION: Telephone think-aloud interviews and qualitative survey data. DATA ANALYSIS: The think-aloud interview data and qualitative survey data were analysed independently using inductive thematic analysis. The findings were subsequently triangulated. RESULTS: Thematic analysis of the telephone interviews generated seven themes: perceived risk; belief in the effectiveness of protective behaviours; acceptability of distancing and isolation; having capacity to perform the behaviours; habit forming reduces effort; having the confidence to perform the behaviours; and social norms affect motivation to engage in the behaviours. The themes identified from the survey data mapped well onto the interview analysis. Isolating and social distancing at home were less acceptable than cleaning and handwashing, influenced by the need for intimacy with household members. This was especially true in the absence of symptoms and when perceived risk was low. People felt more empowered when they understood that even small changes, such as spending some time apart, were worthwhile to reduce exposure and lessen viral load. CONCLUSIONS: The current study provided valuable insight into the acceptability and feasibility of protective behaviours, and how public health guidance could be incorporated into a behaviour change intervention for the public during a pandemic.

A Web-Based Intervention (Germ Defence) to Increase Handwashing During a Pandemic: Process Evaluations of a Randomized Controlled Trial and Public Dissemination.

BACKGROUND: Washing hands helps prevent transmission of seasonal and pandemic respiratory viruses. In a randomized controlled trial (RCT) during the swine flu outbreak, participants with access to a fully automated, digital intervention promoting handwashing reported washing their hands more often and experienced fewer respiratory tract infections than those without access to the intervention. Based on these findings, the intervention was adapted, renamed as "Germ Defence," and a study was designed to assess the preliminary dissemination of the intervention to the general public to help prevent the spread of seasonal colds and flu. OBJECTIVE: This study compares the process evaluations of the RCT and Germ Defence dissemination to examine (1) how web-based research enrollment procedures affected those who used the intervention, (2) intervention usage in the 2 contexts, and (3) whether increased intentions to wash hands are replicated once disseminated. METHODS: The RCT ran between 2010 and 2012 recruiting participants offline from general practices, with restricted access to the intervention (N=9155). Germ Defence was disseminated as an open access website for use by the general public from 2016 to 2019 (N=624). The process evaluation plan was developed using Medical Research Council guidance and the framework for Analyzing and Measuring Usage and Engagement Data. Both interventions contained a goal-setting section where users self-reported current and intended handwashing behavior across 7 situations. RESULTS: During web-based enrolment, 54.3% (17,511/32,250) of the RCT participants dropped out of the study compared to 36.5% (358/982) of Germ Defence users. Having reached the start of the intervention, 93.8% (8586/9155) of RCT users completed the core section, whereas 65.1% (406/624) of Germ Defence users reached the same point. Users across both studies selected to increase their handwashing in 5 out of 7 situations, including before eating snacks (RCT mean difference 1.040, 95% CI 1.016-1.063; Germ Defence mean difference 0.949, 95% CI 0.766-1.132) and after blowing their nose, sneezing, or coughing (RCT mean difference 0.995, 95% CI 0.972-1.019; Germ Defence mean difference 0.842, 95% CI 0.675-1.008). CONCLUSIONS: By comparing the preliminary dissemination of Germ Defence to the RCT, we were able to examine the potential effects of the research procedures on uptake and attrition such as the sizeable dropout during the RCT enrolment procedure that may have led to a more motivated sample. The Germ Defence study highlighted the points of attrition within the intervention. Despite sample bias in the trial context, the intervention replicated increases in intentions to handwash when used "in the wild." This preliminary dissemination study informed the adaptation of the intervention for the COVID-19 health emergency, and it has now been disseminated globally. TRIAL REGISTRATION: ISRCTN Registry ISRCTN75058295; https://www.isrctn.com/ISRCTN75058295.

Effectiveness of digital interventions to improve household and community infection prevention and control behaviours and to reduce incidence of respiratory and/or gastro-intestinal infections: a rapid systematic review.

BACKGROUND: Digital interventions have potential to efficiently support improved hygiene practices to reduce transmission of COVID-19. OBJECTIVE: To evaluate the evidence for digital interventions to improve hygiene practices within the community. METHODS: We reviewed articles published between 01 January 2000 and 26 May 2019 that presented a controlled trial of a digital intervention to improve hygiene behaviours in the community. We searched MEDLINE, Embase, PsycINFO, Cochrane Controlled Register of Trials (CENTRAL), China National Knowledge Infrastructure and grey literature. Trials in hospitals were excluded, as were trials aiming at prevention of sexually transmitted infections; only target diseases with transmission mechanisms similar to COVID-19 (e.g. respiratory and gastrointestinal infections) were included. Trials had to evaluate a uniquely digital component of an intervention. Study designs were limited to randomised controlled trials, controlled before-and-after trials, and interrupted time series analyses. Outcomes could be either incidence of infections or change in hygiene behaviours. The Risk of Bias 2 tool was used to assess study quality. RESULTS: We found seven studies that met the inclusion criteria. Six studies reported successfully improving self-reported hygiene behaviour or health outcomes, but only one of these six trials, Germ Defence, confirmed improvements using objective measures (reduced consultations and antibiotic prescriptions). Settings included kindergartens, workplaces, and service station restrooms. Modes of delivery were diverse: WeChat, website, text messages, audio messages to mobiles, electronic billboards, and electronic personal care records. Four interventions targeted parents of young children with educational materials. Two targeted the general population; these also used behaviour change techniques or theory to inform the intervention. Only one trial had low risk of bias, Germ Defence; the most common concerns were lack of information about the randomisation, possible bias in reporting of behavioural outcomes, and lack of an analysis plan and possible selective reporting of results. CONCLUSION: There was only one trial that was judged to be at low risk of bias, Germ Defence, which reduced incidence and severity of illness, as confirmed by objective measures. Further evaluation is required to determine the effectiveness of the other interventions reviewed. TRIAL REGISTRATION: PROSPERO CRD42020189919 .

Adapting Behavioral Interventions for a Changing Public Health Context: A Worked Example of Implementing a Digital Intervention During a Global Pandemic Using Rapid Optimisation Methods.

Background: A rigorous approach is needed to inform rapid adaptation and optimisation of behavioral interventions in evolving public health contexts, such as the Covid-19 pandemic. This helps ensure that interventions are relevant, persuasive, and feasible while remaining evidence-based. This paper provides a set of iterative methods to rapidly adapt and optimize an intervention during implementation. These methods are demonstrated through the example of optimizing an effective online handwashing intervention called Germ Defense. Methods: Three revised versions of the intervention were rapidly optimized and launched within short timeframes of 1-2 months. Optimisations were informed by: regular stakeholder engagement; emerging scientific evidence, and changing government guidance; rapid qualitative research (telephone think-aloud interviews and open-text surveys), and analyses of usage data. All feedback was rapidly collated, using the Table of Changes method from the Person-Based Approach to prioritize potential optimisations in terms of their likely impact on behavior change. Written feedback from stakeholders on each new iteration of the intervention also informed specific optimisations of the content. Results: Working closely with clinical stakeholders ensured that the intervention was clinically accurate, for example, confirming that information about transmission and exposure was consistent with evidence. Patient and Public Involvement (PPI) contributors identified important clarifications to intervention content, such as whether Covid-19 can be transmitted via air as well as surfaces, and ensured that information about difficult behaviors (such as self-isolation) was supportive and feasible. Iterative updates were made in line with emerging evidence, including changes to the information about face-coverings and opening windows. Qualitative research provided insights into barriers to engaging with the intervention and target behaviors, with open-text surveys providing a useful supplement to detailed think-aloud interviews. Usage data helped identify common points of disengagement, which guided decisions about optimisations. The Table of Changes was modified to facilitate rapid collation and prioritization of multiple sources of feedback to inform optimisations. Engagement with PPI informed the optimisation process. Conclusions: Rapid optimisation methods of this kind may in future be used to help improve the speed and efficiency of adaptation, optimization, and implementation of interventions, in line with calls for more rapid, pragmatic health research methods.

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.

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.

Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence).

BACKGROUND: To control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. OBJECTIVE: This study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. METHODS: This was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. RESULTS: Current behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). CONCLUSIONS: Self-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

A Framework for Analyzing and Measuring Usage and Engagement Data (AMUsED) in Digital Interventions: Viewpoint.

Trials of digital interventions can yield extensive, in-depth usage data, yet usage analyses tend to focus on broad descriptive summaries of how an intervention has been used by the whole sample. This paper proposes a novel framework to guide systematic, fine-grained usage analyses that better enables understanding of how an intervention works, when, and for whom. The framework comprises three stages to assist in the following: (1) familiarization with the intervention and its relationship to the captured data, (2) identification of meaningful measures of usage and specifying research questions to guide systematic analyses of usage data, and (3) preparation of datasheets and consideration of available analytical methods with which to examine the data. The framework can be applied to inform data capture during the development of a digital intervention and/or in the analysis of data after the completion of an evaluation trial. We will demonstrate how the framework shaped preparation and aided efficient data capture for a digital intervention to lower transmission of cold and flu viruses in the home, as well as how it informed a systematic, in-depth analysis of usage data collected from a separate digital intervention designed to promote self-management of colds and flu. The Analyzing and Measuring Usage and Engagement Data (AMUsED) framework guides systematic and efficient in-depth usage analyses that will support standardized reporting with transparent and replicable findings. These detailed findings may also enable examination of what constitutes effective engagement with particular interventions.

An internet-delivered handwashing intervention to modify influenza-like illness and respiratory infection transmission (PRIMIT): a primary care randomised trial.

BACKGROUND: Handwashing to prevent transmission of respiratory tract infections (RTIs) has been widely advocated, especially during the H1N1 pandemic. However, the role of handwashing is debated, and no good randomised evidence exists among adults in non-deprived settings. We aimed to assess whether an internet-delivered intervention to modify handwashing would reduce the number of RTIs among adults and their household members. METHODS: We recruited individuals sharing a household by mailed invitation through general practices in England. After consent, participants were randomised online by an automated computer-generated random number programme to receive either no access or access to a bespoke automated web-based intervention that maximised handwashing intention, monitored handwashing behaviour, provided tailored feedback, reinforced helpful attitudes and norms, and addressed negative beliefs. We enrolled participants into an additional cohort (randomised to receive intervention or no intervention) to assess whether the baseline questionnaire on handwashing would affect handwashing behaviour. Participants were not masked to intervention allocation, but statistical analysis commands were constructed masked to group. The primary outcome was number of episodes of RTIs in index participants in a modified intention-to-treat population of randomly assigned participants who completed follow-up at 16 weeks. This trial is registered with the ISRCTN registry, number ISRCTN75058295. FINDINGS: Across three winters between Jan 17, 2011, and March 31, 2013, we enrolled 20,066 participants and randomly assigned them to receive intervention (n=10,040) or no intervention (n=10,026). 16,908 (84%) participants were followed up with the 16 week questionnaire (8241 index participants in intervention group and 8667 in control group). After 16 weeks, 4242 individuals (51%) in the intervention group reported one or more episodes of RTI compared with 5135 (59%) in the control group (multivariate risk ratio 0·86, 95% CI 0·83-0·89; p<0·0001). The intervention reduced transmission of RTIs (reported within 1 week of another household member) both to and from the index person. We noted a slight increase in minor self-reported skin irritation (231 [4%] of 5429 in intervention group vs 79 [1%] of 6087 in control group) and no reported serious adverse events. INTERPRETATION: In non-pandemic years, an effective internet intervention designed to increase handwashing could have an important effect in reduction of infection transmission. In view of the heightened concern during a pandemic and the likely role of the internet in access to advice, the intervention also has potential for effective implementation during a pandemic. FUNDING: Medical Research Council.

A pilot study of StopAdvisor: a theory-based interactive internet-based smoking cessation intervention aimed across the social spectrum.

BACKGROUND: This article reports a pilot study of a new smoking cessation website ('StopAdvisor'), which has been developed on the basis of PRIME theory, evidence, web-design expertise and user-testing. The aims were to i) evaluate whether cessation, website usage and satisfaction were sufficiently high to warrant a randomised controlled trial (RCT) and ii) assess whether outcomes were affected by socio-economic status. METHODS: This was an uncontrolled pilot study. Two hundred and four adult daily smokers willing to make a serious quit attempt were included. All participants received support from 'StopAdvisor', which recommends a structured quit plan and a variety of evidence-based behaviour change techniques for smoking cessation. A series of tunnelled sessions and a variety of interactive menus provide tailored support for up to a month before quitting through until one-month post-quit (http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The primary outcome was self-report of at least 1month of continuous abstinence collected at 2months post-enrolment and verified by saliva cotinine or anabasine. Usage was indexed by log-ins and page views. Satisfaction was assessed by dichotomous ratings of helpfulness, personal relevance, likelihood of recommendation and future use, which were collected using an online questionnaire at 2months post-enrolment. Outcomes according to socio-economic status were assessed. RESULTS: At 8weeks post-enrolment, 19.6% (40/204) of participants were abstinent according to the primary outcome criteria (95% C.I.=14.1% to 25.1%). Participants viewed a mean of 133.5 pages (median=71.5) during 6.4 log-ins (median=3). A majority of respondents rated the website positively on each of the four satisfaction `ratings (range=66.7% to 75.3%). There was no evidence of an effect of socio-economic status on abstinence (OR=1.01, C.I.=0.50-2.07), usage (page-views, t(202)=0.11, p=.91; log-ins, t(202)=0.21, p=.83), or satisfaction (helpfulness, OR=1.09, C.I.=0.41-2.88; personal relevance, OR=0.55, C.I.=0.20-1.56; recommendation, OR=0.98, C.I.=0.34-2.81; use in future, OR=1.45, C.I.=0.49-4.27). CONCLUSIONS: The systematic application of theory, evidence, web-design expertise, and user-testing has resulted in a website that shows sufficiently promising efficacy and usability to warrant evaluation in a RCT. The website appears to be similarly effective and acceptable to users across the social spectrum.

Development of an intervention to reduce transmission of respiratory infections and pandemic flu: measuring and predicting hand-washing intentions.

This was an exploratory pilot study forming part of a programme of work to develop and trial an effective web-based intervention to reduce the risk of transmission of respiratory infections by promoting hand washing and other preventive behaviours in pandemic and non-pandemic contexts. The main purpose of this study was to confirm that the behavioural determinants we had identified from theory were related as predicted to intentions and to establish the validity of our measures of behavioural intentions. Participants (N = 84) completed a self-report web-delivered questionnaire measuring intentions to engage in hand washing and the hypothesised behavioural determinants of intentions, based on the theory of planned behaviour and protection motivation theory. In a factorial 2 × 2 design, half of the participants were first randomised to receive messages about potential negative consequences of pandemic flu (the "high-threat" condition) and half were assigned to receive "coping" messages describing the rationale and effectiveness of hand washing for reducing the risk of infection. A substantial proportion of variance in intentions was explained by measures of attitudes (instrumental and affective), social norms (descriptive and injunctive), perceived behavioural control (especially, access to hand gel) and perceived risk (in particular, the likelihood of catching pandemic flu). Our measures of intentions were sensitive to between-group differences, and although our design did not permit causal inference (particularly in view of selective dropout among those required to read most web pages), the pattern of differences was in the expected direction, that is, hand-washing intentions tended to be stronger in those receiving the high-threat message and coping messages. This study provided encouraging confirmation that our intervention development was proceeding correctly. Measures of intentions proved sensitive to group differences, and the behavioural determinants included in the study explained a substantial proportion of the variance in intentions. The study also provided useful indications that our high-threat message might increase hand-washing intentions, that providing hand gel might be beneficial and that it would be necessary to actively manage the risk of selective dropout in the intervention group.

Development of StopAdvisor: A theory-based interactive internet-based smoking cessation intervention.

Reviews of internet-based behaviour-change interventions have shown that they can be effective but there is considerable heterogeneity and effect sizes are generally small. In order to advance science and technology in this area, it is essential to be able to build on principles and evidence of behaviour change in an incremental manner. We report the development of an interactive smoking cessation website, StopAdvisor, designed to be attractive and effective across the social spectrum. It was informed by a broad motivational theory (PRIME), empirical evidence, web-design expertise, and user-testing. The intervention was developed using an open-source web-development platform, 'LifeGuide', designed to facilitate optimisation and collaboration. We identified 19 theoretical propositions, 33 evidence- or theory-based behaviour change techniques, 26 web-design principles and nine principles from user-testing. These were synthesised to create the website, 'StopAdvisor' (see http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The systematic and transparent application of theory, evidence, web-design expertise and user-testing within an open-source development platform can provide a basis for multi-phase optimisation contributing to an 'incremental technology' of behaviour change.

Evaluation of a Web-based intervention to promote hand hygiene: exploratory randomized controlled trial.

BACKGROUND: Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. OBJECTIVE: The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory infection Transmission). METHODS: In a parallel-group pragmatic exploratory trial design, 517 nonblinded adults recruited through primary care were automatically randomly assigned to a fully automated intervention comprising 4 sessions of tailored motivational messages and self-regulation support (n = 324) or to a no-intervention control group (n = 179; ratio 2:1). Hand-washing frequency and theory of planned behavior cognitions relating to hand-washing were assessed by online questionnaires at baseline (in only half of the control participants, to permit evaluation of effects of baseline assessment on effect sizes), at 4 weeks (postintervention; all participants), and at 12 weeks. RESULTS: Hand-washing rates in the intervention group were higher at 4 weeks than in the control group (mean 4.40, n = 285 and mean 4.04, n = 157, respectively; P < .001, Cohen d = 0.42) and remained higher at 12 weeks (mean 4.45, n = 282 and mean 4.12, n = 154, respectively; P < .001, Cohen d = 0.34). Hand-washing intentions and positive attitudes toward hand-washing increased more from baseline to 4 weeks in the intervention group than in the control group. Mediation analyses revealed positive indirect effects of the intervention on change in hand-washing via intentions (coefficient = .15, 95% confidence interval [CI], .08-.26) and attitudes (coefficient = 0.16, 95% CI, .09-.26). Moderator analyses confirmed that the intervention was similarly effective for men and women, those of higher and lower socioeconomic status, and those with higher and lower levels of perceived risk. CONCLUSIONS: This study provides promising evidence that Web-based interventions could potentially provide an effective method of promoting hand hygiene in the home. Data were collected during the 2010 influenza pandemic, when participants in both groups had already been exposed to extensive publicity about the need for hand hygiene, suggesting that our intervention could add to existing public health campaigns. However, further research is required to determine the effects of the intervention on actual infection rates. TRIAL: International Standard Randomized Controlled Trial Number (ISRCTN): 75058295; http://www.controlled-trials.com/ISRCTN75058295 (Archived by WebCite at http://www.webcitation.org/62KSbkNmm).