Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.

BACKGROUND: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. METHODS: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. RESULTS: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), "satisfaction with my wear of orthopaedic footwear" was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. CONCLUSIONS: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. TRIAL REGISTRATION: Netherlands Trial Register NL7710. Registered: 6 May 2019.

Addendum: The Dutch COVID-19 Notification App: Lessons Learned From a Mixed Methods Evaluation Among End Users and Contact-Tracing Employees.

[This corrects the article DOI: 10.2196/38904.].

The Dutch COVID-19 Notification App: Lessons Learned From a Mixed Methods Evaluation Among End Users and Contact-Tracing Employees.

BACKGROUND: The Dutch CoronaMelder (CM) app is the official Dutch contact-tracing app (CTA). It has been used to contain the spread of the SARS-CoV-2 in the Netherlands. It allows its users and those of connected apps to anonymously exchange warnings about potentially high-risk contacts with individuals infected with the SARS-CoV-2. OBJECTIVE: The goal of this mixed methods study is to understand the use of CTA in the pandemic and its integration into the Municipal Health Services (MHS) efforts of containment through contact tracing. Moreover, the study aims to investigate both the motivations and user experience-related factors concerning adherence to quarantine and isolation measures. METHODS: A topic analysis of 56 emails and a web-based survey of 1937 adults from the Netherlands, combined with a series of 48 in-depth interviews with end users of the app and 14 employees of the Dutch MHS involved in contact tracing, were conducted. Mirroring sessions were held (n=2) with representatives from the development (n=2) and communication teams (n=2) responsible for the creation and implementation of the CM app. RESULTS: Topic analysis and interviews identified procedural and technical issues in the use of the CTA. Procedural issues included the lack of training of MHS employees in the use of CTAs. Technical issues identified for the end users included the inability to send notifications without phone contact with the MHS, unwarranted notifications, and nightly notifications. Together, these issues undermined confidence in and satisfaction with the app's use. The interviews offered a deeper understanding of the various factors at play and their effects on users; for example, the mixed experiences of the app's users, the end user's own fears, and uncertainties concerning the SARS-CoV-2; problematic infrastructure at the time of the app's implementation on the side of the health services; the effects of the society-wide efforts in containment of the SARS-CoV-2 on the CM app's perception, resulting in further doubts concerning the app's effectiveness among MHS workers and citizens; and problems with adherence to behavioral measures propagated by the app because of the lack of confidence in the app and uncertainty concerning the execution of the behavioral measures. All findings were evaluated with the app's creators and have since contributed to improvements. CONCLUSIONS: Although most participants perceived the app positively, procedural and technical issues identified in this study limited satisfaction and confidence in the CM app and affected its adoption and long-term use. Moreover, these same issues negatively affected the CM app's effectiveness in improving compliance with behavioral measures aimed at reducing the spread of the SARS-CoV-2. This study offers lessons learned for future eHealth interventions in pandemics. Lessons that can aid in more effective design, implementation, and communication for more effective and readily adoptable eHealth applications.

Combining Persuasive System Design Principles and Behavior Change Techniques in Digital Interventions Supporting Long-term Weight Loss Maintenance: Design and Development of eCHANGE.

BACKGROUND: Long-term weight maintenance after weight loss is challenging, and innovative solutions are required. Digital technologies can support behavior change and, therefore, have the potential to be an effective tool for weight loss maintenance. However, to create meaningful and effective digital behavior change interventions that support end user values and needs, a combination of persuasive system design (PSD) principles and behavior change techniques (BCTs) might be needed. OBJECTIVE: This study aimed to investigate how an evidence-informed digital behavior change intervention can be designed and developed by combining PSD principles and BCTs into design features to support end user values and needs for long-term weight loss maintenance. METHODS: This study presents a concept for how PSD principles and BCTs can be translated into design features by combining design thinking and Agile methods to develop and deliver an evidence-informed digital behavior change intervention aimed at supporting weight maintenance. Overall, 45 stakeholders participated in the systematic and iterative development process comprising co-design workshops, prototyping, Agile development, and usability testing. This included prospective end users (n=17, 38%; ie, people with obesity who had lost ≥8% of their weight), health care providers (n=9, 20%), healthy volunteers (n=4, 9%), a service designer (n=1, 2%), and stakeholders from the multidisciplinary research and development team (n=14, 31%; ie, software developers; digital designers; and eHealth, behavior change, and obesity experts). Stakeholder input on how to operationalize the design features and optimize the technology was examined through formative evaluation and qualitative analyses using rapid and in-depth analysis approaches. RESULTS: A total of 17 design features combining PSD principles and BCTs were identified as important to support end user values and needs based on stakeholder input during the design and development of eCHANGE, a digital intervention to support long-term weight loss maintenance. The design features were combined into 4 main intervention components: Week Plan, My Overview, Knowledge and Skills, and Virtual Coach and Smart Feedback System. To support a healthy lifestyle and continued behavior change to maintain weight, PSD principles such as tailoring, personalization, self-monitoring, reminders, rewards, rehearsal, praise, and suggestions were combined and implemented into the design features together with BCTs from the clusters of goals and planning, feedback and monitoring, social support, repetition and substitution, shaping knowledge, natural consequences, associations, antecedents, identity, and self-belief. CONCLUSIONS: Combining and implementing PSD principles and BCTs in digital interventions aimed at supporting sustainable behavior change may contribute to the design of engaging and motivating interventions in line with end user values and needs. As such, the design and development of the eCHANGE intervention can provide valuable input for future design and tailoring of evidence-informed digital interventions, even beyond digital interventions in support of health behavior change and long-term weight loss maintenance. TRIAL REGISTRATION: ClinicalTrials.gov NCT04537988; https://clinicaltrials.gov/ct2/show/NCT04537988.

Toward the Value Sensitive Design of eHealth Technologies to Support Self-management of Cardiovascular Diseases: Content Analysis.

BACKGROUND: eHealth can revolutionize the way self-management support is offered to chronically ill individuals such as those with a cardiovascular disease (CVD). However, patients' fluctuating motivation to actually perform self-management is an important factor for which to account. Tailoring and personalizing eHealth to fit with the values of individuals promises to be an effective motivational strategy. Nevertheless, how specific eHealth technologies and design features could potentially contribute to values of individuals with a CVD has not been explicitly studied before. OBJECTIVE: This study sought to connect a set of empirically validated, health-related values of individuals with a CVD with existing eHealth technologies and their design features. The study searched for potential connections between design features and values with the goal to advance knowledge about how eHealth technologies can actually be more meaningful and motivating for end users. METHODS: Undertaking a technical investigation that fits with the value sensitive design framework, a content analysis of existing eHealth technologies was conducted. We matched 11 empirically validated values of CVD patients with 70 design features from 10 eHealth technologies that were previously identified in a systematic review. The analysis consisted mainly of a deductive coding stage performed independently by 3 members of the study team. In addition, researchers and developers of 6 of the 10 reviewed technologies provided input about potential feature-value connections. RESULTS: In total, 98 connections were made between eHealth design features and patient values. This meant that some design features could contribute to multiple values. Importantly, some values were more often addressed than others. CVD patients' values most often addressed were related to (1) having or maintaining a healthy lifestyle, (2) having an overview of personal health data, (3) having reliable information and advice, (4) having extrinsic motivators to accomplish goals or health-related activities, and (5) receiving personalized care. In contrast, values less often addressed concerned (6) perceiving low thresholds to access health care, (7) receiving social support, (8) preserving a sense of autonomy over life, and (9) not feeling fear, anxiety, or insecurity about health. Last, 2 largely unaddressed values were related to (10) having confidence and self-efficacy in the treatment or ability to achieve goals and (11) desiring to be seen as a person rather than a patient. CONCLUSIONS: Positively, existing eHealth technologies could be connected with CVD patients' values, largely through design features that relate to educational support, self-monitoring support, behavior change support, feedback, and motivational incentives. Other design features such as reminders, prompts or cues, peer-based or expert-based human support, and general system personalization were also connected with values but in narrower ways. In future studies, the inferred feature-value connections must be validated with empirical data from individuals with a CVD or similar chronic conditions.

Values of Importance to Patients With Cardiovascular Disease as a Foundation for eHealth Design and Evaluation: Mixed Methods Study.

BACKGROUND: eHealth interventions are developed to support and facilitate patients with lifestyle changes and self-care tasks after being diagnosed with a cardiovascular disease (CVD). Creating long-lasting effects on lifestyle change and health outcomes with eHealth interventions is challenging and requires good understanding of patient values. OBJECTIVE: The aim of the study was to identify values of importance to patients with CVD to aid in designing a technological lifestyle platform. METHODS: A mixed method design was applied, combining data from usability testing with an additional online survey study, to validate the outcomes of the usability tests. RESULTS: A total of 11 relevant patient values were identified, including the need for security, support, not wanting to feel anxious, tailoring of treatment, and personalized, accessible care. The validation survey shows that all values but one (value 9: To have extrinsic motivation to accomplish goals or activities [related to health/lifestyle]) were regarded as important/very important. A rating of very unimportant or unimportant was given by less than 2% of the respondents (value 1: 4/641, 0.6%; value 2: 10/641, 1.6%; value 3: 9/641, 1.4%; value 4: 5/641, 0.8%; value 5: 10/641, 1.6%; value 6: 4/641, 0.6%; value 7: 10/639, 1.6%; value 8: 4/639, 0.6%; value 10: 3/636, 0.5%; value 11: 4/636, 0.6%) to all values except but one (value 9: 56/636, 8.8%). CONCLUSIONS: There is a high consensus among patients regarding the identified values reflecting goals and themes central to their lives, while living with or managing their CVD. The identified values can serve as a foundation for future research to translate and integrate these values into the design of the eHealth technology. This may call for prioritization of values, as not all values can be met equally.

Barriers and Facilitators Associated With App-Based Treatment for Female Urinary Incontinence: Mixed Methods Evaluation.

BACKGROUND: App-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use. OBJECTIVE: The goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure. METHODS: We used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment. RESULTS: Four interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms). CONCLUSIONS: This study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1002/nau.23507.

Can a monologue-style ECA more effectively motivate eHealth users in initial distress than textual guidance?

Stress is a prevalent issue amongst patients with chronic conditions. As eHealth interventions are gaining importance, it becomes more relevant to invoke the possibilities from the eHealth technology itself to provide motivational acts during experiences of stress as to enhance adherence to the intervention. Embodied Conversational Agents (ECA's) also known as 'robots on screen' can potentially provide a remedy. Within our eHealth experiment we applied a between-subjects design and experimentally studied the difference in appraisal of motivation and guidance. We deployed a functionally modest, monologue-style ECA and compared them with textual guidance. This way, we filtered out the considerable positive impact of interactive features that go along with dialogue-style ECA's. The study was carried out amongst eHealth users of which half were deliberately put in a stressful pre-condition. The rationale was two-sided; first, we hypothesized that it would induce a need for motivational support. Second, it would provide a fair representation of eHealth users in real life. Furthermore, we investigated hypothesized positive effects from a gender match between participant and ECA. The results demonstrated preferential ECA effects compared to text but only in the no stress conditions. Although our set-up controlled for user distraction by putting the facilitating ECA in a pane separate from the eHealth environment, we suspect that the enduring visual presence of the ECA during task completion had still inhibited distressed users. Discussing this phenomenon, our stance is that the hypothesis that ECA support is always superior to textual guidance is open for re-evaluation. Text may sometimes serve users equally well because it lacks human-like aspects that in stressful circumstances can become confrontational. We discuss the potential of ECA's to motivate, but also elaborate on the caveats. Further implications for the ECA, intervention adherence, and eHealth study fields are discussed in relation to stress.

The Dutch COVID-19 Contact Tracing App (the CoronaMelder): Usability Study.

BACKGROUND: Adoption and evaluation of contact tracing tools based on information and communications technology may expand the reach and efficacy of traditional contact tracing methods in fighting COVID-19. The Dutch Ministry of Health, Welfare and Sports initiated and developed CoronaMelder, a COVID-19 contact tracing app. This app is based on a Google/Apple Exposure Notification approach and aims to combat the spread of the coronavirus among individuals by notifying those who are at increased risk of infection due to proximity to someone who later tests positive for COVID-19. The app should support traditional contact tracing by faster tracing and greater reach compared to regular contact tracing procedures. OBJECTIVE: The main goal of this study is to investigate whether the CoronaMelder is able to support traditional contact tracing employed by public health authorities. To achieve this, usability tests were conducted to answer the following question: is the CoronaMelder user-friendly, understandable, reliable and credible, and inclusive? METHODS: Participants (N=44) of different backgrounds were recruited: youth with varying educational levels, youth with an intellectual disability, migrants, adults (aged 40-64 years), and older adults (aged >65 years) via convenience sampling in the region of Twente in the Netherlands. The app was evaluated with scenario-based, think-aloud usability tests and additional interviews. Findings were recorded via voice recordings, observation notes, and the Dutch User Experience Questionnaire, and some participants wore eye trackers to measure gaze behavior. RESULTS: Our results showed that the app is easy to use, although problems occurred with understandability and accessibility. Older adults and youth with a lower education level did not understand why or under what circumstances they would receive notifications, why they must share their key (ie, their assigned identifier), and what happens after sharing. In particular, youth in the lower-education category did not trust or understand Bluetooth signals, or comprehend timing and follow-up activities after a risk exposure notification. Older adults had difficulties multitasking (speaking with a public health worker and simultaneously sharing the key in the app). Public health authorities appeared to be unprepared to receive support from the app during traditional contact tracing because their telephone conversation protocol lacks guidance, explanation, and empathy. CONCLUSIONS: The study indicated that the CoronaMelder app is easy to use, but participants experienced misunderstandings about its functioning. The perceived lack of clarity led to misconceptions about the app, mostly regarding its usefulness and privacy-preserving mechanisms. Tailored and targeted communication through, for example, public campaigns or social media, is necessary to provide correct information about the app to residents in the Netherlands. Additionally, the app should be presented as part of the national coronavirus measures instead of as a stand-alone app offered to the public. Public health workers should be trained to effectively and empathetically instruct users on how to use the CoronaMelder app.

Identifying Persuasive Design Principles and Behavior Change Techniques Supporting End User Values and Needs in eHealth Interventions for Long-Term Weight Loss Maintenance: Qualitative Study.

BACKGROUND: An increasing number of eHealth interventions aim to support healthy behaviors that facilitate weight loss. However, there is limited evidence of the effectiveness of the interventions and little focus on weight loss maintenance. Knowledge about end user values and needs is essential to create meaningful and effective eHealth interventions, and to identify persuasive system design (PSD) principles and behavior change techniques (BCTs) that may contribute to the behavior change required for successful long-term weight loss maintenance. OBJECTIVE: This study aimed to provide insight into the design of eHealth interventions supporting behavior change for long-term weight maintenance. The study sought to identify the values and needs of people with obesity aiming to maintain weight after weight loss, and to identify PSD principles, BCTs, and design requirements that potentially enable an eHealth intervention to meet end user values and needs. METHODS: This study presents the concept of integrating PSD principles and BCTs into the design process of eHealth interventions to meet user values and needs. In this study, individual interviews and focus groups were conducted with people with obesity (n=23) and other key stakeholders (n=27) to explore end user values and needs related to weight loss maintenance. Design thinking methods were applied during the focus group sessions to identify design elements and to explore how eHealth solutions can support the needs to achieve sustainable weight loss maintenance. The PSD model and behavior change taxonomy by Michie were used to identify PSD principles and BCT clusters to meet end user values and needs. RESULTS: A total of 8 key end user values were identified, reflecting user needs for weight loss maintenance support: self-management, personalized care, autonomy, feel supported, positive self-image, motivation, happiness, and health. Goals and planning, feedback and monitoring, repetition and substitution, shaping knowledge, social support, identity, and self-belief were some of the BCT clusters identified to address these concepts, together with PSD principles such as personalization, tailoring, self-monitoring, praise, and suggestions. CONCLUSIONS: The process of translating end user values and needs into design elements or features of eHealth technologies is an important part of the design process. To our knowledge, this is the first study to explore how PSD principles and BCTs can be integrated when designing eHealth self-management interventions for long-term weight loss maintenance. End users and other key stakeholders highlighted important factors to be considered in the design of eHealth interventions supporting sustained behavior change. The PSD principles and BCTs identified provide insights and suggestions about design elements and features to include for supporting weight loss maintenance. The findings indicate that a combination of BCTs and PSD principles may be needed in evidence-based eHealth interventions to stimulate motivation and adherence to support healthy behaviors and sustained weight loss maintenance. TRIAL REGISTRATION: ClinicalTrials.gov NCT04537988; https://clinicaltrials.gov/ct2/show/NCT04537988.

Applying an Agent-based Model to Simulate Just-In-Time Support for Keeping Users of eLearning Courses Motivated.

Persuasive technology can support users of self-paced eLearning courses during critical moments of low motivation. Agent-based models (ABMs) - a relatively unfamiliar phenomenon within the persuasive technology and eLearning domains- offers a potentially relevant methodology to understand when the support should be delivered. Using ABMs, the dynamics of motivational user states can be simulated. Subsequently, emerging user patterns can be traced that can potentially provide insight in the ebb and flow of motivation. For the purpose of this study, we designed an exploratory ABM on motivation based on the mental energy notion of which the foundations can be found both within the literature of motivational psychology and agent-based modeling. During the simulations we succeeded in generating moments of critically low user motivation. In addition, we were able to simulate the positive impact of external user support at those critical moments. These results suggest that it is plausible to put further energy in developing ABM models with the ultimate goal of feeding persuasive technology with the ability to deliver just-in-time user support during eLearning.

Supporting Self-Management of Cardiovascular Diseases Through Remote Monitoring Technologies: Metaethnography Review of Frameworks, Models, and Theories Used in Research and Development.

BACKGROUND: Electronic health (eHealth) is a rapidly evolving field informed by multiple scientific disciplines. Because of this, the use of different terms and concepts to explain the same phenomena and lack of standardization in reporting interventions often leaves a gap that hinders knowledge accumulation. Interventions focused on self-management support of cardiovascular diseases through the use of remote monitoring technologies are a cross-disciplinary area potentially affected by this gap. A review of the underlying frameworks, models, and theories that have informed projects at this crossroad could advance future research and development efforts. OBJECTIVE: This research aimed to identify and compare underlying approaches that have informed interventions focused on self-management support of cardiovascular diseases through the use of remote monitoring technologies. The objective was to achieve an understanding of the distinct approaches by highlighting common or conflicting principles, guidelines, and methods. METHODS: The metaethnography approach was used to review and synthesize researchers' reports on how they applied frameworks, models, and theories in their projects. Literature was systematically searched in 7 databases: Scopus, Web of Science, EMBASE, CINAHL, PsycINFO, Association for Computing Machinery Digital Library, and Cochrane Library. Included studies were thoroughly read and coded to extract data for the synthesis. Studies were mainly related by the key ingredients of the underlying approaches they applied. The key ingredients were finally translated across studies and synthesized into thematic clusters. RESULTS: Of 1224 initial results, 17 articles were included. The articles described research and development of 10 different projects. Frameworks, models, and theories (n=43) applied by the projects were identified. Key ingredients (n=293) of the included articles were mapped to the following themes of eHealth development: (1) it is a participatory process; (2) it creates new infrastructures for improving health care, health, and well-being; (3) it is intertwined with implementation; (4) it integrates theory, evidence, and participatory approaches for persuasive design; (5) it requires continuous evaluation cycles; (6) it targets behavior change; (7) it targets technology adoption; and (8) it targets health-related outcomes. CONCLUSIONS: The findings of this review support and exemplify the numerous possibilities in the use of frameworks, models, and theories to guide research and development of eHealth. Participatory, user-centered design, and integration with empirical evidence and theoretical modeling were widely identified principles in the literature. On the contrary, less attention has been given to the integration of implementation in the development process and supporting novel eHealth-based health care infrastructures. To better integrate theory and evidence, holistic approaches can combine patient-centered studies with consolidated knowledge from expert-based approaches. TRIAL REGISTRATION: PROSPERO CRD42018104397; https://tinyurl.com/y8ajyajt. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13334.

Evaluating the implementation of a personal health record for chronic primary and secondary care: a mixed methods approach.

BACKGROUND: Personal health records (PHRs) provide the opportunity for self-management support, enhancing communication between patients and caregivers, and maintaining and/or improving the quality of chronic disease management. Their implementation is a multi-level and complex process, requiring a holistic approach that takes into account the technology, its users and the context of implementation. The aim of this research is to evaluate the fidelity of a PHR in chronic care (the degree to which it was implemented as intended) in order to explain the found effects. METHODS: A convergent parallel mixed methods design was used, where qualitative and quantitative data were collected in parallel, analyzed separately, and finally merged. Log data of 536 users were used to gain insight into the actual long-term use of the PHR (the dose). Focus group meetings among caregivers (n = 13) were conducted to assess program differentiation (or intended use). Interviews with caregivers (n = 28) and usability tests with potential end-users (n = 13) of the PHR were used to understand the responsiveness and the differences and similarities between the intended and actual use of the PHR. RESULTS: The results of the focus groups showed that services for coaching are strongly associated with monitoring health values and education. However, the PHR was not used that way during the study period. In the interviews, caregivers indicated that they were ignorant on how to deploy the PHR in current working routines. Therefore, they find it difficult to motivate their patients in using the PHR. Participants in the usability study indicate that they would value a PHR in the future, given that the usability will be improved and that the caregivers will use it in daily practice as well. CONCLUSIONS: In this study, actual use of the PHRs by patients was influenced by the responsiveness of caregivers. This responsiveness is likely to be strongly influenced by the perceived support when defining the differentiation and delivery of the PHR. A mixed-methods approach to understand intervention fidelity was of added value in providing explanations for the found effects that could not be revealed by solely focusing on the effectiveness of the technology in an experimental trial.

Persuasive System Design Principles and Behavior Change Techniques to Stimulate Motivation and Adherence in Electronic Health Interventions to Support Weight Loss Maintenance: Scoping Review.

BACKGROUND: Maintaining weight after weight loss is a major health challenge, and eHealth (electronic health) solutions may be a way to meet this challenge. Application of behavior change techniques (BCTs) and persuasive system design (PSD) principles in eHealth development may contribute to the design of technologies that positively influence behavior and motivation to support the sustainable health behavior change needed. OBJECTIVE: This review aimed to identify BCTs and PSD principles applied in eHealth interventions to support weight loss and weight loss maintenance, as well as techniques and principles applied to stimulate motivation and adherence for long-term weight loss maintenance. METHODS: A systematic literature search was conducted in PsycINFO, Ovid MEDLINE (including PubMed), EMBASE, Scopus, Web of Science, and AMED, from January 1, 2007 to June 30, 2018. Arksey and O'Malley's scoping review methodology was applied. Publications on eHealth interventions were included if focusing on weight loss or weight loss maintenance, in combination with motivation or adherence and behavior change. RESULTS: The search identified 317 publications, of which 45 met the inclusion criteria. Of the 45 publications, 11 (24%) focused on weight loss maintenance, and 34 (76%) focused on weight loss. Mobile phones were the most frequently used technology (28/45, 62%). Frequently used wearables were activity trackers (14/45, 31%), as well as other monitoring technologies such as wireless or digital scales (8/45, 18%). All included publications were anchored in behavior change theories. Feedback and monitoring and goals and planning were core behavior change technique clusters applied in the majority of included publications. Social support and associations through prompts and cues to support and maintain new habits were more frequently used in weight loss maintenance than weight loss interventions. In both types of interventions, frequently applied persuasive principles were self-monitoring, goal setting, and feedback. Tailoring, reminders, personalization, and rewards were additional principles frequently applied in weight loss maintenance interventions. Results did not reveal an ideal combination of techniques or principles to stimulate motivation, adherence, and weight loss maintenance. However, the most frequently mentioned individual techniques and principles applied to stimulate motivation were, personalization, simulation, praise, and feedback, whereas associations were frequently mentioned to stimulate adherence. eHealth interventions that found significant effects for weight loss maintenance all applied self-monitoring, feedback, goal setting, and shaping knowledge, combined with a human social support component to support healthy behaviors. CONCLUSIONS: To our knowledge, this is the first review examining key BCTs and PSD principles applied in weight loss maintenance interventions compared with those of weight loss interventions. This review identified several techniques and principles applied to stimulate motivation and adherence. Future research should aim to examine which eHealth design combinations can be the most effective in support of long-term behavior change and weight loss maintenance.

An Empirical Study of a Pedagogical Agent as an Adjunct to an eHealth Self-Management Intervention: What Modalities Does It Need to Successfully Support and Motivate Users?

Prior research has shown that the more patients know about their disease, health, and lifestyle the better the health outcomes are. Patients who are suffering from either a physical disease with mental consequences or from mental illnesses can contribute to their own feeling of mental well-being by following evidence-based online, self-guided therapeutic interventions. These self-guided therapeutic interventions during which there is no contact with a care provider have shown high effectiveness. However, users (patients) of self-guided eHealth interventions have difficulties fulfilling the entire trajectory as is mirrored in high non-adherence rates. Users have reported a need for support, that is traditionally provided by human care providers. This study investigates the opportunities from within the technology to increase its support level toward the user. We deployed a pedagogical agent acting as an adjunct to a self-guided positive psychology psycho-education intervention. This agent provided instructions and user support in between and explicitly not during the online learning modules as to mitigate the risk of distraction. By setting up a between-subjects design and deploying three versions of a pedagogical agent (also known as Embodied Conversational Agent), varying the features of animation, speech, and visibility we investigated whether users felt more supported than by a fourth text-only control condition. All four conditions provided similar task-related support and emotion-related support to the user. Our results showed that our pedagogical agent made users feel guided and supported with respect to fulfilling their tasks. However, no effects were found of emotion-related support resulting in higher user motivation and an improved learning experience. Significant effects of visibility and voice were found, but animation of our pedagogical agent had no effect. On the feedback outcome variable, we found a gender effect. Male participants graded the visible Embodied Conversational Agent (ECA) higher than female participants and graded the non-visible ECA lower than female participants. In our view, ECA's should not necessarily be deployed with the ambition to compete with the profound human potential to deliver support and guidance. Exploring ECA capabilities merits further attention, from the stance that the technology itself can support users and potentially make them adhere.

The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting.

AIMS: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. METHODS: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI ≥ 2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. CONCLUSION: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.

Clarifying the Concept of Adherence to eHealth Technology: Systematic Review on When Usage Becomes Adherence.

BACKGROUND: In electronic health (eHealth) evaluations, there is increasing attention for studying the actual usage of a technology in relation to the outcomes found, often by studying the adherence to the technology. On the basis of the definition of adherence, we suggest that the following three elements are necessary to determine adherence to eHealth technology: (1) the ability to measure the usage behavior of individuals; (2) an operationalization of intended use; and (3) an empirical, theoretical, or rational justification of the intended use. However, to date, little is known on how to operationalize the intended usage of and the adherence to different types of eHealth technology. OBJECTIVE: The study aimed to improve eHealth evaluations by gaining insight into when, how, and by whom the concept of adherence has been used in previous eHealth evaluations and finding a concise way to operationalize adherence to and intended use of different eHealth technologies. METHODS: A systematic review of eHealth evaluations was conducted to gain insight into how the use of the technology was measured, how adherence to different types of technologies was operationalized, and if and how the intended use of the technology was justified. Differences in variables between the use of the technology and the operationalization of adherence were calculated using a chi-square test of independence. RESULTS: In total, 62 studies were included in this review. In 34 studies, adherence was operationalized as "the more use, the better," whereas 28 studies described a threshold for intended use of the technology as well. Out of these 28, only 6 reported a justification for the intended use. The proportion of evaluations of mental health technologies reporting a justified operationalization of intended use is lagging behind compared with evaluations of lifestyle and chronic care technologies. The results indicated that a justification of intended use does not require extra measurements to determine adherence to the technology. CONCLUSIONS: The results of this review showed that to date, justifications for intended use are often missing in evaluations of adherence. Evidently, it is not always possible to estimate the intended use of a technology. However, such measures do not meet the definition of adherence and should therefore be referred to as the actual usage of the technology. Therefore, it can be concluded that adherence to eHealth technology is an underdeveloped and often improperly used concept in the existing body of literature. When defining the intended use of a technology and selecting valid measures for adherence, the goal or the assumed working mechanisms should be leading. Adherence can then be standardized, which will improve the comparison of adherence rates to different technologies with the same goal and will provide insight into how adherence to different elements contributed to the outcomes.

Self-Guided Web-Based Interventions: Scoping Review on User Needs and the Potential of Embodied Conversational Agents to Address Them.

BACKGROUND: Web-based mental health interventions have evolved from innovative prototypes to evidence-based and clinically applied solutions for mental diseases such as depression and anxiety. Open-access, self-guided types of these solutions hold the promise of reaching and treating a large population at a reasonable cost. However, a considerable factor that currently hinders the effectiveness of these self-guided Web-based interventions is the high level of nonadherence. The absence of a human caregiver apparently has a negative effect on user adherence. It is unknown to what extent this human support can be handed over to the technology of the intervention to mitigate this negative effect. OBJECTIVE: The first objective of this paper was to explore what is known in literature about what support a user needs to stay motivated and engaged in an electronic health (eHealth) intervention that requires repeated use. The second objective was to explore the current potential of embodied conversational agents (ECAs) to provide this support. METHODS: This study reviews and interprets the available literature on (1) support within eHealth interventions that require repeated use and (2) the potential of ECAs by means of a scoping review. The rationale for choosing a scoping review is that the subject is broad, diverse, and largely unexplored. Themes for (1) and (2) were proposed based on grounded theory and mapped on each other to find relationships. RESULTS: The results of the first part of this study suggest the presence of user needs that largely remain implicit and unaddressed. These support needs can be categorized as task-related support and emotion-related support. The results of the second part of this study suggest that ECAs are capable of engaging and motivating users of information technology applications in the domains of learning and behavioral change. Longitudinal studies must be conducted to determine under what circumstances ECAs can create and maintain a productive user relationship. Mapping the user needs on the ECAs' capabilities suggests that different kinds of ECAs may provide different solutions for improving the adherence levels. CONCLUSIONS: Autonomous ECAs that do not respond to a user's expressed emotion in real time but take on empathic roles may be sufficient to motivate users to some extent. It is unclear whether those types of ECAs are competent enough and create sufficient believability among users to address the user's deeper needs for support and empathy. Responsive ECAs may offer a better solution. However, at present, most of these ECAs have difficulties to assess a user's emotional state in real time during an open dialogue. By conducting future research with relationship theory-based ECAs, the added value of ECAs toward user needs can be better understood.

Key Components in eHealth Interventions Combining Self-Tracking and Persuasive eCoaching to Promote a Healthier Lifestyle: A Scoping Review.

BACKGROUND: The combination of self-tracking and persuasive eCoaching in automated interventions is a new and promising approach for healthy lifestyle management. OBJECTIVE: The aim of this study was to identify key components of self-tracking and persuasive eCoaching in automated healthy lifestyle interventions that contribute to their effectiveness on health outcomes, usability, and adherence. A secondary aim was to identify the way in which these key components should be designed to contribute to improved health outcomes, usability, and adherence. METHODS: The scoping review methodology proposed by Arskey and O'Malley was applied. Scopus, EMBASE, PsycINFO, and PubMed were searched for publications dated from January 1, 2013 to January 31, 2016 that included (1) self-tracking, (2) persuasive eCoaching, and (3) healthy lifestyle intervention. RESULTS: The search resulted in 32 publications, 17 of which provided results regarding the effect on health outcomes, 27 of which provided results regarding usability, and 13 of which provided results regarding adherence. Among the 32 publications, 27 described an intervention. The most commonly applied persuasive eCoaching components in the described interventions were personalization (n=24), suggestion (n=19), goal-setting (n=17), simulation (n=17), and reminders (n=15). As for self-tracking components, most interventions utilized an accelerometer to measure steps (n=11). Furthermore, the medium through which the user could access the intervention was usually a mobile phone (n=10). The following key components and their specific design seem to influence both health outcomes and usability in a positive way: reduction by setting short-term goals to eventually reach long-term goals, personalization of goals, praise messages, reminders to input self-tracking data into the technology, use of validity-tested devices, integration of self-tracking and persuasive eCoaching, and provision of face-to-face instructions during implementation. In addition, health outcomes or usability were not negatively affected when more effort was requested from participants to input data into the technology. The data extracted from the included publications provided limited ability to identify key components for adherence. However, one key component was identified for both usability and adherence, namely the provision of personalized content. CONCLUSIONS: This scoping review provides a first overview of the key components in automated healthy lifestyle interventions combining self-tracking and persuasive eCoaching that can be utilized during the development of such interventions. Future studies should focus on the identification of key components for effects on adherence, as adherence is a prerequisite for an intervention to be effective.

Health Behavior Change Support Systems as a research discipline; A viewpoint.

As research on Health Behavior Change Support Systems (HBCSS) proliferates, meaningful management of the different findings is becoming a challenge. We argue that for the field to evolve, it is important to establish the study of HBCSSs as an independent research area, which means that instead of only applying theories from related disciplines to HBCSSs, we need to significantly extend and adapt these theories, or develop new theories, to explain the phenomena that are encountered. Current research in HBCSSs is carried out in different disciplines, with a different approach in each of these disciplines. However, both the CeHRes roadmap and the Persuasive System Design Model show that HBCSSs are complex and the development and evaluation of these systems need to deal with this complexity to be successful. Therefore, an integrative approach is needed to study the combination of content, system, and context. Although research into the separate areas has yielded important findings that are discussed in this paper, we argue that an integrated approach of HBCSSs is useful. We discuss two examples to show how a truly integrative approach can be utilized to enhance the field involving tailoring, personalization, and support. In conclusion we present three practical and relatively easy-to-implement recommendations for researchers who want to contribute to this discipline: Avoid the black box, be specific about the terms used, and look past the borders of one's own discipline.