Ingrid Muller

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.

Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial

Objective To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care. Design Single blind, parallel group, pragmatic, randomised controlled trial. Setting 35 general practices across southern England between October 2008 and January 2011. Participants Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient). Interventions Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist. Main outcome measures Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY). Results Of 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference −1.79 (95% confidence interval −3.69 tο 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support −2.52 (−4.52 to −0.51), P=0.014; booklet only −2.43 (−4.27 to −0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488;

Telephone-delivered cognitive behavioural therapy: a systematic review and meta-analysis

1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year. Conclusions Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care. Trial registration ClinicalTrials.gov NCT00732797.

Supporting Self-Care for Families of Children With Eczema With a Web-Based Intervention Plus Health Care Professional Support: Pilot Randomized Controlled Trial

Telephone-delivered cognitive behavioural therapy (CBT) is an increasingly popular mode of delivering care. We conducted a systematic review which focused on physical health outcomes. Literature searches were conducted to identify randomized controlled trials (RCTs) comparing telephone-delivered CBT for improving physical health with any other therapy or routine care in patients with chronic illness. Eight RCTs (1093 patients) met the eligibility criteria and were included in the review. Six of the eight RCTs compared the telephone intervention with routine care, one trial employed symptom monitoring as the control condition and the final trial compared telephone CBT to telephone supportive emotion-focused therapy. Meta-analysis found that telephone-delivered CBT significantly improved physical health in people with chronic illness (d = 0.225, 95% CI = 0.105, 0.344). Moderator analyses found that less therapist contact was associated with better outcomes, and telephone-delivered CBT was more effective for chronic illnesses that are not immediately life-threatening. The results of the meta-analysis support the use of telephone-delivered CBT as a tool for improving health in people with chronic illness. There is a need for future trials to evaluate cost-effectiveness.

The person-based approach to enhancing the acceptability and feasibility of interventions

Background Childhood eczema, or childhood atopic dermatitis, causes significant distress to children and their families through sleep disturbance and itch. The main cause of treatment failure is nonuse of prescribed treatments. Objective The objective of this study was to develop and test a Web-based intervention to support families of children with eczema, and to explore whether support from a health care professional (HCP) is necessary to engage participants with the intervention. Methods We followed the PRECEDE-PROCEED model: regular emollient use was the target behavior we were seeking to promote and we identified potential techniques to influence this. LifeGuide software was used to write the intervention website. Carers of children with eczema were invited through primary care mail-out and randomized to 3 groups: (1) website only, (2) website plus HCP support, or (3) usual care. Patient-Oriented Eczema Measure (POEM) scores were measured online by carer report at baseline and at 12 weeks. Qualitative interviews were carried out with 13 HCPs (primarily practice nurses) and 26 participants to explore their experiences of taking part in the study. Results A total of 143 carers were recruited through 31 practices. We found a decrease of ≥2 in follow-up compared with baseline POEM score in 23 of 42 (55%) participants in the website only group, 16 of 49 (33%) in the usual care group, and 18 of 47 (38%) in the website plus HCP group. Website use data showed that 75 of 93 (81%) participants allocated to the website groups completed the core modules, but less than half used other key components (videos: 35%; regular text reminders: 39%). There were no consistent differences in website use between the website only or the website plus HCP groups. Qualitative feedback showed that most HCPs had initial concerns about providing support for eczema self-care because this was not a condition that they felt expert in. However, HCPs reported productive consultations and that they found it helpful to use the website in consultations, while observing that some participants seemed to need more support than others. Qualitative interviews with participants suggested that HCP support was valued highly only by a minority, generally those who were less confident in their management of eczema or less confident using the Internet. Conclusions Our pilot trial demonstrated the potential for greater improvements in POEM scores in both website intervention groups and that a full-scale trial is feasible. Such a trial would quantify the effectiveness and cost-effectiveness of this intervention to determine whether it should be widely promoted to families of children with newly diagnosed eczema. In this study population, HCP support was not strongly valued by participants and did not lead to better outcomes or website use than use of the Web-based intervention alone. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 98560867; http://www.controlled-trials.com/ISRCTN98560867 (Archived by WebCite at http://www.webcitation.org/6NcxvMtgN).

Views of People With High and Low Levels of Health Literacy About a Digital Intervention to Promote Physical Activity for Diabetes: A Qualitative Study in Five Countries

BackgroundThis paper provides three illustrations of how the “person-based approach” can be used to assess and enhance the acceptability and feasibility of an intervention during the early stages of development and evaluation. The person-based approach involves using mixed methods research to systematically investigate the beliefs, attitudes, needs and situation of the people who will be using the intervention. The in-depth understanding of users’ perspectives derived from this research then enables intervention developers to design or modify the intervention to make it more relevant, persuasive, accessible and engaging.MethodsThe first illustration describes how relevant beliefs and attitudes of people with asthma were identified from the existing qualitative and quantitative literature and then used to create guiding principles to inform the design of a web-based intervention to improve quality of life. The second illustration describes how qualitative “think-aloud” interviews and patient and public involvement (PPI) input are used to improve the acceptability of a booklet for people with asthma. In the third illustration, iterative think-aloud methods are used to create a more accurate and accessible activity planner for people with diabetes.ResultsIn the first illustration of the person-based approach, we present the guiding principles we developed to summarise key design issues/objectives and key intervention features to address them. The second illustration provides evidence from interviews that positive, non-medical messages and images were preferred in booklet materials for people with asthma. The third illustration demonstrates that people with diabetes found it difficult to complete an online activity planner accurately, resulting in incorrect personalised advice being given prior to appropriate modification of the planner.ConclusionsThe person-based approach to intervention development can complement theory- and evidence-based development and participant input into intervention design, offering a systematic process for systematically investigating and incorporating the views of a wide range of users.

Understanding patient experiences of self-managing chronic dizziness: a qualitative study of booklet-based vestibular rehabilitation, with or without remote support

Background Low health literacy is associated with poor health-related knowledge, illness self-management, health service use, health, and survival, and thus addressing issues related to low health literacy has been highlighted as a pressing international priority. Objective To explore views of a digital health promotion intervention designed to be accessible to people with lower levels of health literacy, in particular examining reactions to the interactive and audiovisual elements of the intervention. Methods Qualitative think-aloud interviews were carried out with 65 adults with type 2 diabetes in the UK, Ireland, USA, Germany, and Austria, with purposive sampling to ensure representation of people with lower levels of health literacy. Inductive thematic analysis was used to identify common themes. We then systematically compared views in subgroups based on country, health literacy level, age, gender, and time since diagnosis. Results Most participants from the chosen countries expressed positive views of most elements and features of the intervention. Some interactive and audiovisual elements required modification to increase their usability and perceived credibility and relevance. There were some differences in views based on age and gender, but very few differences relating to health literacy level or time since diagnosis. Conclusions In general, participants found the intervention content and format accessible, appropriate, engaging, and motivating. Digital interventions can and should be designed to be accessible and engaging for people with a wide range of health literacy levels.

‘You don't know which bits to believe’: qualitative study exploring carers’ experiences of seeking information on the internet about childhood eczema

Objective This study explores participants’ experience of self-management of dizziness using booklet-based vestibular rehabilitation (VR), with or without expert telephone support. Design Semistructured qualitative interviews were conducted. Setting Participants were recruited from primary care practices as part of a large RCT. Participants Interviews were carried out with 33 people (10 men and 23 women; age 27–84) self-managing chronic dizziness using booklet-based vestibular rehabilitation, with or without expert telephone support. Results Data were analysed using inductive thematic analysis. The majority of participants in both groups reported a positive experience of VR therapy, with many participants reporting an improvement in their dizziness symptoms since undertaking the therapy. Participants in the telephone support group felt that a genuine relationship developed between them and their therapist within three short sessions, and described their therapy sessions as reassuring, encouraging and motivational. Conclusions The VR treatment booklet appears to be a valued tool for self-managing chronic dizziness and people appreciate receiving remote telephone support. Trial registration number NCT00732797.

Carers’ views of topical-corticosteroid use in childhood eczema: a qualitative study of online discussion forums

Objective We sought to explore parents and carers’ experiences of searching for information about childhood eczema on the internet. Design A qualitative interview study was carried out among carers of children aged 5 years or less with a recorded diagnosis of eczema. The main focus of the study was to explore carers’ beliefs and understandings around eczema and its treatment. As part of this, we explored experiences of formal and informal information seeking about childhood eczema. Transcripts of interviews were analysed thematically. Setting Participants were recruited from six general practices in South West England. Participants Interviews were carried out with 31 parents from 28 families. Results Experiences of searching for eczema information on the internet varied widely. A few interviewees were able to navigate through the internet and find the specific information they were looking for (for instance about treatments their child had been prescribed), but more found searching for eczema information online to be a bewildering experience. Some could find no information of relevance to them, whereas others found the volume of different information sources overwhelming. Some said that they were unsure how to evaluate online information or that they were wary of commercial interests behind some information sources. Interviewees said that they would welcome more signposting towards high quality information from their healthcare providers. Conclusions We found very mixed experiences of seeking eczema information on the internet; but many participants in this study found this to be frustrating and confusing. Healthcare professionals and healthcare systems have a role to play in helping people with long-term health conditions and their carers find reliable online information to support them with self-care.

The therapeutic relationship in telephone-delivered support for people undertaking rehabilitation: a mixed-methods interaction analysis

Childhood eczema is very common and can have substantial impact on quality of life. One of the main treatments is topical corticosteroids, but these are often underused by parents and carers for reasons that include concerns about safety.