Katherine Bradbury

The person-based approach to intervention development: application to digital health-related behavior change interventions.

This paper describes an approach that we have evolved for developing successful digital interventions to help people manage their health or illness. We refer to this as the “person-based” approach to highlight the focus on understanding and accommodating the perspectives of the people who will use the intervention. While all intervention designers seek to elicit and incorporate the views of target users in a variety of ways, the person-based approach offers a distinctive and systematic means of addressing the user experience of intended behavior change techniques in particular and can enhance the use of theory-based and evidence-based approaches to intervention development. There are two key elements to the person-based approach. The first is a developmental process involving qualitative research with a wide range of people from the target user populations, carried out at every stage of intervention development, from planning to feasibility testing and implementation. This process goes beyond assessing acceptability, usability, and satisfaction, allowing the intervention designers to build a deep understanding of the psychosocial context of users and their views of the behavioral elements of the intervention. Insights from this process can be used to anticipate and interpret intervention usage and outcomes, and most importantly to modify the intervention to make it more persuasive, feasible, and relevant to users. The second element of the person-based approach is to identify “guiding principles” that can inspire and inform the intervention development by highlighting the distinctive ways that the intervention will address key context-specific behavioral issues. This paper describes how to implement the person-based approach, illustrating the process with examples of the insights gained from our experience of carrying out over a thousand interviews with users, while developing public health and illness management interventions that have proven effective in trials involving tens of thousands of users.

Does Brief Telephone Support Improve Engagement With a Web-Based Weight Management Intervention? Randomized Controlled Trial

Background Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes. Objective We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss. Methods Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report. Results Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ2 1=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F 2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not. Conclusions In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy).

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial

BACKGROUND The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. METHODS We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. FINDINGS Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. INTERPRETATION Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. FUNDING Health Technology Assessment Programme of the National Institute for Health Research.

Integrating user perspectives into the development of a web-based weight management intervention

The objective of this study was to adapt the design of our weight management intervention to the needs, expectations and capabilities of potential users. In study 1, we interviewed 25 people about their experiences of weight management. The findings of these interviews were combined with findings from existing theory and research in a process of ‘intervention planning’ that informed the design of the intervention. Study 2 comprised in‐depth think‐aloud studies with a further 16 people interested in using a web‐based intervention to manage their weight, in order to elicit reactions to the intervention techniques and materials. In study 1, overly intrusive and restrictive aspects of eating self‐regulation were commonly cited reasons for failure to maintain weight management long‐term. We therefore designed an intervention with a more flexible approach to autonomous self‐regulation. This approach was broadly welcomed in study 2, but there were indications that some participants might have difficulty effectively implementing self‐regulation techniques independently. A flexible and autonomous approach to changing eating habits is attractive to potential intervention users but may be difficult for some users to implement successfully.

Using mixed methods to develop and evaluate an online weight management intervention

PURPOSE This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction (POWeR) programme, an e-health intervention designed to support sustainable weight loss. The studies outlined also explore how human support might enhance intervention usage and weight loss. METHODS Mixed methods were used to develop and evaluate POWeR. In the development phase, we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention. Next, a feasibility trial, with nested qualitative study, explored what level of human support might lead to the most sustainable weight loss. Finally, a large community-based trial of POWeR, with nested qualitative study, explored whether the addition of brief telephone coaching enhances usage. RESULTS Findings suggest that POWeR is acceptable and potentially effective. Providing human support enhanced usage in our trials, but was not unproblematic. Interestingly, there were some indications that more basic (brief) human support may produce more sustainable weight loss outcomes than more regular support. Qualitative interviews suggested that more regular support might foster reliance, meaning patients cannot sustain their weight losses when support ends. Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support. CONCLUSIONS Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry. Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions. Statement of contribution What is already known on this subject? There is evidence that human support may increase the effectiveness of e-health interventions. It is unclear what level of human support might be optimal or how human support improves effectiveness. Triangulation of quantitative and qualitative methods can be used to inform the design and implementation of interventions What does this study add? This paper demonstrates the value of a mixed methods approach when developing and evaluating an intervention. Qualitative methods provided complementary insights into the optimal level of human support. Brief human support is valued by some and may enhance usage and outcomes of an e-health intervention for weight loss.

Developing digital interventions: a methodological guide

Digital interventions are becoming an increasingly popular method of delivering healthcare as they enable and promote patient self-management. This paper provides a methodological guide to the processes involved in developing effective digital interventions, detailing how to plan and develop such interventions to avoid common pitfalls. It demonstrates the need for mixed qualitative and quantitative methods in order to develop digital interventions which are effective, feasible, and acceptable to users and stakeholders.

Patients' appraisals of public and private healthcare: a qualitative study of physiotherapy and osteopathy.

Patients have previously reported differences in their experiences of treatments received in the public and private sectors; it remains unclear whether such perceived differences are particular to or shared across different interventions. This study explored whether patients’ appraisals of public and private treatments are similar when appraising a complementary therapy (osteopathy) compared to a mainstream therapy (physiotherapy). Thirty-five qualitative interviews were analysed thematically. Patients’ appraisals varied by health-care sector and therapy type: physiotherapy was appraised more negatively in the National Health Service than the private sector but osteopathy was appraised similarly within both health-care sectors. Potential reasons for this are discussed.

Intervention planning for a digital intervention for self-management of hypertension: a theory-, evidence- and person-based approach

BackgroundThis paper describes the intervention planning process for the Home and Online Management and Evaluation of Blood Pressure (HOME BP), a digital intervention to promote hypertension self-management. It illustrates how a Person-Based Approach can be integrated with theory- and evidence-based approaches. The Person-Based Approach to intervention development emphasises the use of qualitative research to ensure that the intervention is acceptable, persuasive, engaging and easy to implement.MethodsOur intervention planning process comprised two parallel, integrated work streams, which combined theory-, evidence- and person-based elements. The first work stream involved collating evidence from a mixed methods feasibility study, a systematic review and a synthesis of qualitative research. This evidence was analysed to identify likely barriers and facilitators to uptake and implementation as well as design features that should be incorporated in the HOME BP intervention. The second work stream used three complementary approaches to theoretical modelling: developing brief guiding principles for intervention design, causal modelling to map behaviour change techniques in the intervention onto the Behaviour Change Wheel and Normalisation Process Theory frameworks, and developing a logic model.ResultsThe different elements of our integrated approach to intervention planning yielded important, complementary insights into how to design the intervention to maximise acceptability and ease of implementation by both patients and health professionals. From the primary and secondary evidence, we identified key barriers to overcome (such as patient and health professional concerns about side effects of escalating medication) and effective intervention ingredients (such as providing in-person support for making healthy behaviour changes). Our guiding principles highlighted unique design features that could address these issues (such as online reassurance and procedures for managing concerns). Causal modelling ensured that all relevant behavioural determinants had been addressed, and provided a complete description of the intervention. Our logic model linked the hypothesised mechanisms of action of our intervention to existing psychological theory.ConclusionOur integrated approach to intervention development, combining theory-, evidence- and person-based approaches, increased the clarity, comprehensiveness and confidence of our theoretical modelling and enabled us to ground our intervention in an in-depth understanding of the barriers and facilitators most relevant to this specific intervention and user population.

How Do People with Multiple Sclerosis Experience Prognostic Uncertainty and Prognosis Communication? A Qualitative Study.

Background Disease progression in multiple sclerosis (MS) is highly variable and predicting prognosis is notoriously challenging. Patients’ prognosis beliefs, responses to prognostic uncertainty and experiences of prognosis-related communication with healthcare professionals (HCPs) have received little study. These issues have implications for patients’ psychological adjustment and are important in the context of the recent development of personalised prognosis forecasting tools. This study explored patient perspectives on the experience of prognostic uncertainty, the formation of expectations about personal prognosis and the nature of received and desired prognosis communication. Methods 15 MS patients participated in in-depth semi-structured interviews which were analysed using inductive thematic analysis. Results Six themes captured key aspects of the data: Experiencing unsatisfactory communication with HCPs, Appreciating and accepting prognostic uncertainty, Trying to stay present-focused, Forming and editing personal prognosis beliefs, Ambivalence towards forecasting the future, and Prognosis information delivery. MS patients report having minimal communication with HCPs about prognosis. Over time MS patients appear to develop expectations about their disease trajectories, but do so with minimal HCP input. Provision of prognosis information by HCPs seems to run counter to patients’ attempts to remain present-focused. Patients are often ambivalent about prognosis forecasting and consider it emotionally dangerous and of circumscribed usefulness. Conclusions HCPs must carefully consider whether, when and how to share prognosis information with patients; specific training may be beneficial. Future research should confirm findings about limited HCP-patient communication, distinguish predictors of patients’ attitudes towards prognostication and identify circumstances under which prognostic forecasting benefits patients.

Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial

Introduction Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. Methods and analysis The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. Ethics and dissemination This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. Trial registration number ISRCTN13790648; pre-results.