White Paper: Open Digital Health - accelerating transparent and scalable health promotion and treatment.

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).

Understanding university student priorities for mental health and well-being support: A mixed-methods exploration using the person-based approach.

Poor student well-being at UK universities is overstretching institutional support services, highlighting a need for effective new resources. Despite extensive literature on mental health and well-being interventions, students' engagement with support remains unexplored. The study aimed to understand students' experience of engagement with well-being support, identify their well-being needs and form concrete recommendations for future intervention design and delivery. The Person-Based Approach to intervention design was followed to centralise users' experience, in turn maximising acceptability and effectiveness of resources. An online survey (N = 52) was followed by three focus groups (N = 14). Survey data were analysed descriptively, and reflexive thematic analysis was performed on qualitative data. Mixed-methods data integration produced four key student priorities for well-being resources - ease of access, inclusive and preventative approach, sense of community and a safe space, and applying skills to real-life contexts. Five actionable guiding principles for intervention design were produced through consultation with expert stakeholders. This work helps understand why and how students engage with support at university. The resulting recommendations can inform future intervention development, leading to more acceptable, engaging and effective student well-being resources.

Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews.

OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.

The Detrimental Clinical Associations of Anxiety and Depression with Difficult Asthma Outcomes

Difficult asthma describes asthma in which comorbidities, inadequate treatment, suboptimal inhaler technique and/or poor adherence impede good asthma control. The association of anxiety and depression with difficult asthma outcomes (exacerbations, hospital admissions, asthma control, etc.) is unclear. This study assessed the clinical associations of anxiety and depression with difficult asthma outcomes in patients with a specialist diagnosis of difficult asthma. Using real-world data, we retrospectively phenotyped patients from the Wessex Asthma Cohort of Difficult Asthma (N = 441) using clinical diagnoses of anxiety and depression against those without anxiety or depression (controls). Additionally, we stratified patients by severity of psychological distress using the Hospital Anxiety and Depression Scale (HADS). We found that depression and/or anxiety were reported in 43.1% of subjects and were associated with worse disease-related questionnaire scores. Each psychological comorbidity group showed differential associations with difficult asthma outcomes. Anxiety alone (7.9%) was associated with dysfunctional breathing and more hospitalisations [anxiety, median (IQR): 0 (2) vs. controls: 0 (0)], while depression alone (11.6%) was associated with obesity and obstructive sleep apnoea. The dual anxiety and depression group (23.6%) displayed multimorbidity, worse asthma outcomes, female predominance and earlier asthma onset. Worse HADS-A scores in patients with anxiety were associated with worse subjective outcomes (questionnaire scores), while worse HADS-D scores in patients with depression were associated with worse objective (ICU admissions and maintenance oral corticosteroid requirements) and subjective outcomes. In conclusion, anxiety and depression are common in difficult asthma but exert differential detrimental effects. Difficult asthma patients with dual anxiety and depression experience worse asthma outcomes alongside worse measures of psychological distress. There is a severity-gradient association of HADS scores with worse difficult asthma outcomes. Collectively, our findings highlight the need for holistic, multidisciplinary approaches that promote early identification and management of anxiety and depression in difficult asthma patients.

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.

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.