Lina Weinert

Aim: To evaluate the efficacy of a digital health companion app as an adjunct to systematic periodontal therapy. Methods: Seven German university dental centres conducted this multi‐centre randomised controlled trial. Adults with periodontitis ( n = 194) were assigned to standard periodontal care with or without the Paro‐ComPas app. The primary endpoint was the gingival bleeding index (GBI) at baseline, re‐evaluation and during supportive periodontal care. Secondary outcomes included plaque and bleeding on probing. Confirmatory analyses used longitudinal mixed‐effects regression. Exploratory analyses examined clinical outcomes by app usage cluster. Results: Of the 180 participants, 148 completed the trial. Both groups showed substantial clinical improvements. The unadjusted between‐group difference favoured the control group [7.70 pp (0.55; 14.85) at T0–T2]; the adjusted analysis showed no significant difference in the primary endpoint (1.56 pp; p = 0.352) or in secondary endpoints. Implementation fidelity was suboptimal. Exploratory analyses revealed that moderate app users achieved significantly greater plaque reductions compared to low users (−14.95 pp; p = 0.034). Conclusions: This trial found no significant benefit of a digital companion app as an adjunct to systematic periodontal therapy. Low baseline inflammation, incomplete intervention delivery and inter‐examiner variability likely limited detection of small effects. Exploratory findings suggest potential benefits among moderately engaged users. Trial Registration: The study was registered in an international trial register (German Clinical Trial Register number DRKS00031263, registration date 19/06/2023, https://www.drks.de/search/de/trial/DRKS00031263/details )

Aim: The objectives of this study were to gain a comprehensive understanding of patients' barriers to adherence to periodontal treatment and to derive intervention functions for a digital companion to support them through their therapy journey. Materials and Methods: A qualitative study incorporating patient and expert interviews was designed. Data were analysed using thematic analysis. Barriers to therapy adherence and functions for a digital intervention were synthesised with the help of the Capability, Opportunity and Motivation behaviour change model. Results: Barriers related to periodontal therapy are a lack of awareness of the patients' own responsibility and prioritisation of individual oral health, lack of time to both instruct as well as learn and perform better oral hygiene and lack of knowledge about disease characteristics and ideal habits. Participants expected that a digital intervention should incorporate personalised and comprehensive educational material, possibilities to visually document progress, simple descriptions of oral hygiene tasks, reminders and the inclusion of prompts for self‐reflection. Conclusion: While a digital health companion has the potential to address the aforementioned barriers, future research should also aim to develop strategies to focus on health systems barriers (e.g., financing and workforce arrangements) as these can influence patient engagement and adherence.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).

Background: In recent years, breast cancer treatment has taken the path toward personalized medicine. Based on individual tumor biology, therapy tailored to the particular subtype of cancer is increasingly being used. The aim here is to find the most suitable therapy for the disease. However, the success of therapy depends to a large extent on the patient’s adherence to treatment. This, in turn, depends on how the therapy is tolerated and how the treatment team cares for the patient. Patient-centered care seeks to identify and address the individual needs of each patient and to find the best form of care for that person. Objective: In order to improve comprehensive oncological care of patients with breast cancer, the ENABLE trial digitally recorded the health-related quality of life (HRQoL), adverse events (AEs), and patient satisfaction using a mobile smartphone app. The trial provided individualized responses to reported AEs and offered assistance. Additionally, it assessed the impact of a patient-reported outcome–based intervention across various therapy settings. Methods: Patients with breast cancer were eligible to participate in the study before neoadjuvant, adjuvant, postneoadjuvant, or palliative systemic therapy against breast cancer was initiated at the Heidelberg, Mannheim, and Tuebingen, Germany, university hospitals. After 1:1 randomization into an intervention and a control group, HRQoL assessments were performed at six fixed time points during the therapy using validated questionnaires. In the intervention group, HRQoL was also assessed briefly every week using a visual analog scale (EQ-VAS). In cases of significant deterioration, therapy-associated side effects were assessed in a graduated manner, recommendations were sent to the patient, and the treatment team was informed. Additionally, the app served as an “eHealth companion” for education, training, and organizational support during therapy. Results: Recruitment started in March 2021; follow-up was completed in February 2024. In total, 606 patients were enrolled, and 592 patients participated in the study. Enrollment was completed in September 2023, and the last visit was in February 2024. The first results are expected to be published in Q2 2025. Conclusions: Participation in the intervention group is expected to improve treatment satisfaction, adherence, detection, and timely treatment of critical AEs. The close-meshed, weekly, brief HRQoL assessment will also be tested as a screening tool to detect relevant side effects during therapy. The study offers a more objective HRQoL assessment across treatment strategies. Trial Registration: Deutsches Register Klinischer Studien DRKS00025611; https://drks.de/search/en/trial/DRKS00025611 International Registered Report Identifier (IRRID): DERR1-10.2196/69855

Background: Chronic heart failure (CHF) affects over 64 million people globally and often reduces quality of life (QoL), contributing to higher mortality. Wearable devices offer opportunities for continuous monitoring and self-management. However, patient characteristics and perceptions of wearables vary, and healthcare practitioners (HCPs) lack guidance on identifying patients who would benefit from such tools. This study investigates patients’ experiences with wearables for self-monitoring and develops personas to assist HCPs in tailoring CHF management. Methods: A mixed-methods approach was used, combining qualitative semi-structured interviews and quantitative QoL data via the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). CHF patients received an Apple Watch and iPhone SE for tracking vital data and completing questionnaires and participated in semi-structured interviews. Descriptive analysis of KCCQ-12 scores and thematic analysis of interview transcripts informed the creation of patient personas based on previous findings. Results: Thematic analysis identified six main themes, including self-monitoring practices, barriers, and factors influencing acceptance. Most patients used wearables daily, reporting benefits like increased health awareness and improved communication with doctors. Barriers included technical issues and difficulty integrating study devices with personal ones. Quantitative analysis suggested a tendency toward higher QoL among interview participants. Four personas emerged, reflecting varying levels of motivation, literacy, and disease burden. Conclusion: Wearables show promise for improving CHF self-management by enhancing health awareness and providing reassurance. However, technical issues and integration challenges remain barriers. The developed personas offer HCPs a practical tool to personalize care and identify patients most likely to benefit from wearables.

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Background: Wearable devices, mobile technologies, and their combination have been accepted into clinical use to better assess the physical fitness and quality of life of patients and as preventive measures. Usability is pivotal for overcoming constraints and gaining users’ acceptance of technology such as wearables and their companion mobile health (mHealth) apps. However, owing to limitations in design and evaluation, interactive wearables and mHealth apps have often been restricted from their full potential. Objective: This study aims to identify studies that have incorporated wearable devices and determine their frequency of use in conjunction with mHealth apps or their combination. Specifically, this study aims to understand the attributes and evaluation techniques used to evaluate usability in the health care domain for these technologies and their combinations. Methods: We conducted an extensive search across 4 electronic databases, spanning the last 30 years up to December 2021. Studies including the keywords “wearable devices,” “mobile apps,” “mHealth apps,” “physiological data,” “usability,” “user experience,” and “user evaluation” were considered for inclusion. A team of 5 reviewers screened the collected publications and charted the features based on the research questions. Subsequently, we categorized these characteristics following existing usability and wearable taxonomies. We applied a methodological framework for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. Results: A total of 382 reports were identified from the search strategy, and 68 articles were included. Most of the studies (57/68, 84%) involved the simultaneous use of wearables and connected mobile apps. Wrist-worn commercial consumer devices such as wristbands were the most prevalent, accounting for 66% (45/68) of the wearables identified in our review. Approximately half of the data from the medical domain (32/68, 47%) focused on studies involving participants with chronic illnesses or disorders. Overall, 29 usability attributes were identified, and 5 attributes were frequently used for evaluation: satisfaction (34/68, 50%), ease of use (27/68, 40%), user experience (16/68, 24%), perceived usefulness (18/68, 26%), and effectiveness (15/68, 22%). Only 10% (7/68) of the studies used a user- or human-centered design paradigm for usability evaluation. Conclusions: Our scoping review identified the types and categories of wearable devices and mHealth apps, their frequency of use in studies, and their implementation in the medical context. In addition, we examined the usability evaluation of these technologies: methods, attributes, and frameworks. Within the array of available wearables and mHealth apps, health care providers encounter the challenge of selecting devices and companion apps that are effective, user-friendly, and compatible with user interactions. The current gap in usability and user experience in health care research limits our understanding of the strengths and limitations of wearable technologies and their companion apps. Additional research is necessary to overcome these limitations.

Background: Early identification of quality of life (QoL) loss and side effects is a key challenge in breast cancer therapy. Digital tools can be helpful components of therapeutic support. Enable, a smartphone app, was used in a multicenter, prospective randomized controlled trial in 3 breast cancer centers. The app simultaneously serves as a therapy companion (eg, by displaying appointments), a tool for documenting QoL (eg, by enabling data collection for QoL questionnaires), and documentation of patient-reported side effects. The need for digital tools is continually rising. However, evidence of the effects of long-term use of mobile health (mHealth) apps in aftercare for patients with breast cancer is limited. Therefore, evaluating the usability and understanding the user experience of this mHealth app could potentially contribute valuable insights in this field. Objective: A usability study was conducted to explore how patients with breast cancer receiving neoadjuvant, adjuvant, or palliative outpatient treatment rated their engagement with the app , the user experience, and the benefits of using the app. Methods: A mixed methods approach was chosen to combine subjective and objective measures, including an eye-tracking procedure, a standardized usability questionnaire (mHealth App Usability Questionnaire), and semistructured interviews. Participants were surveyed twice during the study period. Interviews were transcribed verbatim and analyzed using thematic analysis. Analysis of the eye-tracking data was carried out using the tracker-integrated software. Descriptive analysis was conducted for the quantitative data. Results: The mHealth App Usability Questionnaire results (n=105) indicated good overall usability for 2 different time points (4 wk: mean 89.15, SD 9.65; 20 wk: mean 85.57, SD 12.88). The qualitative analysis of the eye-tracking recordings (n=10) and interviews (n=16) showed that users found the Enable app easy to use. The design of the app, information about therapies and side effects, and usefulness of the app as a therapy companion were rated positively. Additionally, participants contributed requests for additional app features and suggestions for improving the content and usability of the app. Relevant themes included optimization of the appointment feature, updating the app’s content regularly, and self-administration. In contrast to the app’s current passive method of operation, participants expressed a desire for more active engagement through messaging, alarms, or emails. Conclusions: The results of this study demonstrate the good usability of the Enable app as well as the potential for further development. We concluded from patients’ feedback and requests that mHealth apps could benefit from giving patients a more active role (eg, being able to actively document side effects as they occur). Additionally, regular updates of app content could further contribute to encouraging continued use of mHealth apps. Our findings may also assist other researchers in tailoring their mHealth apps to the actual needs of patients undergoing breast cancer therapy.

Background: Good usability is important for the adoption and continued use of mobile health (mHealth) apps. In particular, high usability can support intuitive use by patients, which improves compliance and increases the app’s effectiveness. However, many usability studies do not use adequate tools to measure perceived usability. The mHealth App Usability Questionnaire (MAUQ) was developed specifically for end users in a medical context. MAUQ is a relatively new but increasingly used questionnaire to evaluate mHealth apps, but it is not yet available in German. Objective: This study aims to translate MAUQ into German and determine its internal consistency, reliability, and construct validity. Methods: This validation study was conducted as part of a usability evaluation project for an mHealth app used as a therapy support tool during breast cancer chemotherapy. MAUQ was translated into German through a rigorous forward-backward translation process, ensuring semantic and conceptual equivalence. Patient responses to MAUQ and System Usability Scale (SUS) were analyzed for validation. Descriptive analysis was performed for the MAUQ subscales and SUS standard scores. Significance tests and correlation coefficients assessed the relationship between the SUS and MAUQ results, confirming construct validity. Internal consistency was assessed for item reliability and consistency in measuring the target construct. Free-text questions assessed translation comprehensibility, with responses analyzed descriptively and qualitatively using content analysis. Results: In this study, 133 participants responded to the questionnaire, and the validation analysis showed substantially positive correlations between the overall MAUQ score and its subscales: ease of use (r=0.56), interface and satisfaction (r=0.75), and usefulness (r=0.83). These findings support the construct validity of MAUQ and emphasize the importance of these subscales in assessing the usability of the Enable app. The correlation coefficients ranging from 0.39 to 0.68 for the items further validate the questionnaire by aligning with the overall score and capturing the intended concept. The high internal consistency reliability of MAUQ (Cronbach α=.81) and its subscales further enhances the instrument’s robustness in accurately evaluating the usability of mHealth apps. Conclusions: We successfully validated the German translation of the MAUQ for stand-alone apps using a standardized approach in a cohort of patients with breast cancer. In our validation study, MAUQ exhibited strong internal consistency reliability (Cronbach α=.81) across its subscales, indicating reliable and consistent measurement. Furthermore, a significant positive correlation (P<.001) was found between the subscales and the overall score, supporting their consistent measurement of the intended construct. Therefore, MAUQ can be considered a reliable instrument for assessing the usability of mHealth apps among German-speaking adults. The availability of the German version of MAUQ will help other researchers in conducting usability studies of mHealth apps in German-speaking cohorts and allow for international comparability of their results.

BACKGROUND Wearable devices, mobile technologies, and their combination have been accepted into clinical use to better assess the physical fitness and quality of life of patients and as preventive measures. Usability is pivotal for overcoming constraints and gaining users’ acceptance of technology such as wearables and their companion mobile health (mHealth) apps. However, owing to limitations in design and evaluation, interactive wearables and mHealth apps have often been restricted from their full potential. OBJECTIVE This study aims to identify studies that have incorporated wearable devices and determine their frequency of use in conjunction with mHealth apps or their combination. Specifically, this study aims to understand the attributes and evaluation techniques used to evaluate usability in the health care domain for these technologies and their combinations. METHODS We conducted an extensive search across 4 electronic databases, spanning the last 30 years up to December 2021. Studies including the keywords “wearable devices,” “mobile apps,” “mHealth apps,” “physiological data,” “usability,” “user experience,” and “user evaluation” were considered for inclusion. A team of 5 reviewers screened the collected publications and charted the features based on the research questions. Subsequently, we categorized these characteristics following existing usability and wearable taxonomies. We applied a methodological framework for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. RESULTS A total of 382 reports were identified from the search strategy, and 68 articles were included. Most of the studies (57/68, 84%) involved the simultaneous use of wearables and connected mobile apps. Wrist-worn commercial consumer devices such as wristbands were the most prevalent, accounting for 66% (45/68) of the wearables identified in our review. Approximately half of the data from the medical domain (32/68, 47%) focused on studies involving participants with chronic illnesses or disorders. Overall, 29 usability attributes were identified, and 5 attributes were frequently used for evaluation: satisfaction (34/68, 50%), ease of use (27/68, 40%), user experience (16/68, 24%), perceived usefulness (18/68, 26%), and effectiveness (15/68, 22%). Only 10% (7/68) of the studies used a user- or human-centered design paradigm for usability evaluation. CONCLUSIONS Our scoping review identified the types and categories of wearable devices and mHealth apps, their frequency of use in studies, and their implementation in the medical context. In addition, we examined the usability evaluation of these technologies: methods, attributes, and frameworks. Within the array of available wearables and mHealth apps, health care providers encounter the challenge of selecting devices and companion apps that are effective, user-friendly, and compatible with user interactions. The current gap in usability and user experience in health care research limits our understanding of the strengths and limitations of wearable technologies and their companion apps. Additional research is necessary to overcome these limitations.