In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the \"patient activation measure\"; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of -5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = -018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402) and heart rate (-0.684; 95% CI = -3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.

UNASSIGNED: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated.
UNASSIGNED: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923).
UNASSIGNED: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group.
UNASSIGNED: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.

BACKGROUND: Mobile eHealth apps have been used as a complementary treatment to increase the quality of life of patients and provide new opportunities for the management of rheumatic diseases. Telemedicine, particularly in the areas of prevention, diagnostics, and therapy, has become an essential cornerstone in the care of patients with rheumatic diseases.
OBJECTIVE: This study aims to improve the design and technology of YogiTherapy and evaluate its usability and quality.
METHODS: We newly implemented the mobile eHealth app YogiTherapy with a modern design, the option to change language, and easy navigation to improve the app\'s usability and quality for patients. After refinement, we evaluated the app by conducting a study with 16 patients with AS (4 female and 12 male; mean age 48.1, SD 16.8 y). We assessed the usability of YogiTherapy with a task performance test (TPT) with a think-aloud protocol and the quality with the German version of the Mobile App Rating Scale (MARS).
RESULTS: In the TPT, the participants had to solve 6 tasks that should be performed on the app. The overall task completion rate in the TPT was high (84/96, 88% completed tasks). Filtering for videos and navigating to perform an assessment test caused the largest issues during the TPT, while registering in the app and watching a yoga video were highly intuitive. Additionally, 12 (75%) of the 16 participants completed the German version of MARS. The quality of YogiTherapy was rated with an average MARS score of 3.79 (SD 0.51) from a maximum score of 5. Furthermore, results from the MARS questionnaire demonstrated a positive evaluation regarding functionality and aesthetics.
CONCLUSIONS: The refined and tested YogiTherapy app showed promising results among most participants. In the future, the app could serve its function as a complementary treatment for patients with AS. For this purpose, surveys with a larger number of patients should still be conducted. As a substantial advancement, we made the app free and openly available on the iOS App and Google Play stores.

BACKGROUND: Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application \"levidex\" was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health.
OBJECTIVE: A previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention\'s impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored.
METHODS: levidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6.
RESULTS: Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13-16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes.
CONCLUSIONS: This pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability.
BACKGROUND: German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.

BACKGROUND: Besides anti-inflammatory medication, physical exercise represents a cornerstone of modern treatment for patients with axial spondyloarthritis (AS). Digital health apps (DHAs) such as the yoga app YogiTherapy could remotely empower patients to autonomously and correctly perform exercises.
OBJECTIVE: This study aimed to design and develop a smartphone-based app, YogiTherapy, for patients with AS. To gain additional insights into the usability of the graphical user interface (GUI) for further development of the app, this study focused exclusively on evaluating users\' interaction with the GUI.
METHODS: The development of the app and the user experience study took place between October 2020 and March 2021. The DHA was designed by engineering students, rheumatologists, and patients with AS. After the initial development process, a pilot version of the app was evaluated by 5 patients and 5 rheumatologists. The participants had to interact with the app\'s GUI and complete 5 navigation tasks within the app. Subsequently, the completion rate and experience questionnaire (attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty) were completed by the patients.
RESULTS: The results of the posttest questionnaires showed that most patients were already familiar with digital apps (4/5, 80%). The task completion rates of the usability test were 100% (5/5) for the tasks T1 and T2, which included selecting and starting a yoga lesson and navigating to an information page. Rheumatologists indicated that they were even more experienced with digital devices (2/5, 40% experts; 3/5, 60% intermediates). In this case, they scored task completion rates of 100% (5/5) for all 5 usability tasks T1 to T5. The mean results from the User Experience Questionnaire range from -3 (most negative) to +3 (most positive). According to rheumatologists\' evaluations, attractiveness (mean 2.267, SD 0.401) and stimulation (mean 2.250, SD 0.354) achieved the best mean results compared with dependability (mean 2.000, SD 0.395). Patients rated attractiveness at a mean of 2.167 (SD 0.565) and stimulation at a mean of 1.950 (SD 0.873). The lowest mean score was reported for perspicuity (mean 1.250, SD 1.425).
CONCLUSIONS: The newly developed and tested DHA YogiTherapy demonstrated moderate usability among rheumatologists and patients with rheumatic diseases. The app can be used by patients with AS as a complementary treatment. The initial evaluation of the GUI identified significant usability problems that need to be addressed before the start of a clinical evaluation. Prospective trials are also needed in the second step to prove the clinical benefits of the app.

BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits.
METHODS: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis.
CONCLUSIONS: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act.
BACKGROUND: German Clinical Trial Register DRKS00022923 . Registered on 22 October 2020.

BACKGROUND: Migraine is a headache disorder with the highest socioeconomic burden. The aim of this study was to deliver the first proof-of-concept data of the potential role of an individual low-glycemic diet provided by a novel digital health application in the prophylaxis of migraine.
METHODS: We analyzed data from a retrospective survey of individuals who participated in a digital nutrition program that provides dietary recommendations based on the individual analysis of continuous glucose measurement from an up to 14-day test phase. A total of 84 individuals completed the retrospective digital survey. The endpoints were changes in the number of migraine days, average duration of attacks, average pain severity, frequency of intake of pain medication, absenteeism, and presenteeism before and after program participation.
RESULTS: The intraindividual comparisons of the endpoints before and after program participation revealed decreases in migraine frequency and other patient-relevant migraine parameters. Moreover, patients with a baseline migraine frequency of two and more migraine days per month and adherence to the dietary recommendations (n = 40) showed a mean reduction in migraine days by 33% with a 50%-responder rate of 38%.
CONCLUSIONS: The data provides emerging evidence that an individualized low-glycemic diet based on continuous glucose measurement could be a promising approach for a diet-based, non-pharmacological migraine prophylaxis. However, future research is required to confirm the implied effectiveness.