Markus Vomhof

Background: Despite approximately half of the German general population not meeting the physical activity (PA)-guidelines of the World Health Organization with further decreases noted during the pandemic, population-based intervention strategies to tackle this public health problem remain sparse. This study aimed to replicate the successfully delivered “10,000 Steps Ghent” intervention and research trial conducted in Belgium, two research questions were examined: (1) Do individuals located in the city that a complex PA intervention is implemented in (Duesseldorf) engage in more PA compared to individuals located in the control city (Wuppertal) after one year? (2) Is the proportion of those reaching 10,000 steps/day higher in the intervention than in the control city after the intervention? Methods: A nonrandomized controlled intervention trial was conducted among residents of two German cities. The 12-month intervention ‘10,000 Steps Duesseldorf’ was designed as a multicomponent intervention targeting different socioecological levels: at the intrapersonal level, a website allowed participants to self-monitor their steps; at the organizational level, workplaces and community groups were engaged through step count competitions; and at the community and policy levels, a city-wide media campaign to increase awareness regarding PA benefits was rolled out and street signage indicating walking routes were posted in different city district of Duesseldorf. To investigate intervention effects, PA was assessed via pedometers in two representative samples of adults aged 25–75 years from Duesseldorf (intervention) and Wuppertal (control). Measurements were taken at baseline (April 2021-March 2022) and again one year later (May–November 2023) and the same participants recorded their steps over a 7-day period at both time points. Baseline differences in socio-demographic and health-related variables between intervention and control were adjusted for in a propensity score model with matching weights. Results: 627 adults completed baseline and 553 the follow-up assessment (60% female, 60% intervention across both timepoints and cities). The results of the propensity score analyses revealed that intervention participants walked an average of 462 steps per day more (95% confidence interval: -146 to 1070) than controls at follow-up. However, the proportion of residents reaching 10,000 steps/day was comparable between intervention and control (Duesseldorf: 26.4%, Wuppertal: 25.6%) after the intervention (odds ratio 1.04, 95% confidence interval: 0.41 to 2.66). Conclusions: Although the increase in step count detected in our study was promising, further intervention efforts and accompanying research are needed to meet the minimally relevant intervention effect of 1000 steps that was set in the original Ghent study. Trial registration: German Clinical Trials Register DRKS00024873 (Date of registration: April 21st, 2021; URL: https://drks.de/search/de/trial/DRKS00024873 ).

Background: Digital mental health interventions (DMHIs) are capable of closing gaps in the prevention and therapy of common mental disorders. Despite their proven effectiveness and approval for prescription, use rates remain low. The reasons include a lack of familiarity and knowledge as well as lasting concerns. Medical students were shown to have a comparatively higher risk for common mental disorders and are thus an important target group for raising awareness about DMHIs. At best, knowledge is already imparted during medical school using context-sensitive information strategies. Yet, little is known about medical students’ information preferences regarding DMHIs. Objective: This study aims to explore information preferences for DMHIs for personal use among medical students in Germany. Methods: A discrete choice experiment was conducted, which was developed using an exploratory sequential mixed methods research approach. In total, 5 attributes (ie, source, delivery mode, timing, recommendation, and quality criteria), each with 3 to 4 levels, were identified using formative research. Data were analyzed using logistic regression models to estimate preference weights and the relative importance of attributes. To identify subgroups of students varying in information preferences, we additionally performed a latent class analysis. Results: Of 309 participants, 231 (74.8%) with reliable data were included in the main analysis (women: 217/309, 70.2%; age: mean 24.1, SD 4.0 y). Overall, the conditional logit model revealed that medical students preferred to receive information about DMHIs from the student council and favored being informed via social media early (ie, during their preclinic phase or their freshman week). Recommendations from other students or health professionals were preferred over recommendations from other users or no recommendations at all. Information about the scientific evidence base was the preferred quality criterion. Overall, the timing of information was the most relevant attribute (32.6%). Latent class analysis revealed 2 distinct subgroups. Class 1 preferred to receive extensive information about DMHIs in a seminar, while class 2 wanted to be informed digitally (via email or social media) and as early as possible in their studies. Conclusions: Medical students reported specific needs and preferences regarding DMHI information provided in medical school. Overall, the timing of information (early in medical education) was considered more important than the information source or delivery mode, which should be prioritized by decision makers (eg, members of faculties of medicine, universities, and ministries of education). Study findings suggest general and subgroup-specific information strategies, which could be implemented in a stepped approach. Easily accessible digital information may promote students’ interest in DMHIs in the first step that might lead to further information-seeking behavior and the attendance of seminars about DMHIs in the second step.

ObjectivesThe objective of this study is to elicit health care preferences of people with diabetes and identify classes of people with different preferences.MethodsA discrete choice experiment was conducted among people with diabetes in Germany comprising attributes of role division in daily diabetes care planning, type of lifestyle education, support for correct medication intake, consultation frequency, emotional support, and time spent on self-management. A conditional logit model and a latent class model were used to elicit preferences toward diabetes care and analyze preference heterogeneity.ResultsA total of 76 people with diabetes, recruited in two specialized diabetes care centers in Germany (mean age 51.9 years, 37.3% women, 49.1% type 2 diabetes mellitus, 50.9% type 1 diabetes mellitus), completed the discrete choice experiment. The most important attributes were consultation frequency, division in daily diabetes care planning, and correct medication intake. The latent class model detected preference heterogeneity by identifying two latent classes which differ mainly with respect to lifestyle education and medication intake.ConclusionWhile the majority of people with diabetes showed preferences in line with current health care provision in Germany, a relevant subgroup wished to strengthen lifestyle education and medication intake support with an aid or website.

We investigate quality provision and the occurrence of strategic behaviour in competitive hospital markets where providers are assumed to be semi-altruistic towards patients. For this, we employ a laboratory experiment with a hospital market framing. Subjects decide on the quality levels for one of three competing hospitals respectively. We vary the organizational aspect of whether quality decisions within hospitals are made by individuals or teams. Realized monetary patient benefits go to real patients outside the lab. In both settings, we find that degrees of cooperation quickly converge towards negative values, implying absence of collusion and patient centred or competitive quality choices. Moreover, hospitals treat quality as a strategic complement and adjust their quality choice in the same direction as their competitors. The response magnitude for team markets is weaker; this is driven by non-cooperative or altruistic teams, which tend to set levels of quality that are strategically independent.

BACKGROUND Digital mental health interventions (DMHIs) are capable of closing gaps in the prevention and therapy of common mental disorders. Despite their proven effectiveness and approval for prescription, use rates remain low. The reasons include a lack of familiarity and knowledge as well as lasting concerns. Medical students were shown to have a comparatively higher risk for common mental disorders and are thus an important target group for raising awareness about DMHIs. At best, knowledge is already imparted during medical school using context-sensitive information strategies. Yet, little is known about medical students’ information preferences regarding DMHIs. OBJECTIVE This study aims to explore information preferences for DMHIs for personal use among medical students in Germany. METHODS A discrete choice experiment was conducted, which was developed using an exploratory sequential mixed methods research approach. In total, 5 attributes (ie, source, delivery mode, timing, recommendation, and quality criteria), each with 3 to 4 levels, were identified using formative research. Data were analyzed using logistic regression models to estimate preference weights and the relative importance of attributes. To identify subgroups of students varying in information preferences, we additionally performed a latent class analysis. RESULTS Of 309 participants, 231 (74.8%) with reliable data were included in the main analysis (women: 217/309, 70.2%; age: mean 24.1, SD 4.0 y). Overall, the conditional logit model revealed that medical students preferred to receive information about DMHIs from the student council and favored being informed via social media early (ie, during their preclinic phase or their freshman week). Recommendations from other students or health professionals were preferred over recommendations from other users or no recommendations at all. Information about the scientific evidence base was the preferred quality criterion. Overall, the timing of information was the most relevant attribute (32.6%). Latent class analysis revealed 2 distinct subgroups. Class 1 preferred to receive extensive information about DMHIs in a seminar, while class 2 wanted to be informed digitally (via email or social media) and as early as possible in their studies. CONCLUSIONS Medical students reported specific needs and preferences regarding DMHI information provided in medical school. Overall, the timing of information (early in medical education) was considered more important than the information source or delivery mode, which should be prioritized by decision makers (eg, members of faculties of medicine, universities, and ministries of education). Study findings suggest general and subgroup-specific information strategies, which could be implemented in a stepped approach. Easily accessible digital information may promote students’ interest in DMHIs in the first step that might lead to further information-seeking behavior and the attendance of seminars about DMHIs in the second step.

Background: Chronic ischemic heart disease (IHD) is one of the leading causes of morbidity and mortality. Physical activity (PA) is an effective secondary preventive strategy in IHD management. The German IHD treatment guideline recommends that general practitioners (GPs) should deliver advice on PA to patients with IHD. However, this recommendation seems inadequately implemented, often due to GP’s insufficient specific training. International guidelines therefore recommend training GPs in how to deliver such advice effectively and efficiently. Currently, evidence is lacking on whether such training can enhance the frequency and quality of PA advice in routine care. The OptiCor project aims to develop and evaluate a training for GPs in the delivery of very brief PA advice to optimise the treatment of people with IHD in German general practice. Methods: OptiCor comprises three study phases over five years according to the Medical Research Council framework recommendations for developing and evaluating complex interventions. Phase 1 (needs analysis): A nationwide representative household survey will be conducted to collect data on receipt and type of GP-delivered PA advice in people with IHD. Focus group discussions and qualitative interviews with GPs and people with IHD will be conducted to explore, e.g. attitudes, motivation towards, experiences with, and barriers and facilitators of PA advice implementation or reception, respectively. The findings will inform the training development. Phase 2 (pilot): A pragmatic cluster randomised controlled trial (cRCT) on the effectiveness of the developed training on proportions of GP-delivered PA advice during routine care of IHD patients will be piloted. Phase 3 (evaluation): A full cRCT will be conducted with the patient-reported proportions of GP-delivered PA advice as primary endpoint. Health economic and process-related data will be collected to facilitate a potential future broad implementation and health economic evaluation of the training. Discussion: If the developed training successfully improves proportions and quality of GP delivered PA advice to patients with IHD, it could serve as a low-threshold and sustainable strategy for implementing PA recommendations in the secondary prevention of IHD in routine GP practice. This training could also potentially be transferred and applied to other chronic diseases or other health care settings. Trial registration: Most work packages (WPs) of this study build on each other over a period of five years. First WPs will inform the final design and methodology of the planned trials (pilot study (WP5) and main study (WP6)). WP5 and WP6 will therefore be prospectively registered with the German Register of Clinical Trials (DRKS) during the course of the project. The ongoing cross-sectional population survey (WP1) has been prospectively registered at DRKS (DRKS00031304, 19/06/2023).

The effectiveness of the multimodal Telemedical Lifestyle Intervention Program (TeLIPro) was proven in the advanced stages of type 2 diabetes mellitus (T2DM). Since its therapeutic potential focusing on telemedical coaching without using a formula diet is unknown, we evaluated improvements in HbA_1c, HbA_1c normalisation rate, cardiometabolic risk factors, quality-of-life, and eating behaviour in real life. In this randomized-controlled trial, AOK Rhineland/Hamburg insured T2DM patients (n = 1163) were randomized (1:1) into two parallel groups, and 817 received the allocated intervention. In addition to routine care, all participants got scales, step counters, and access to an online portal. The TeLIPro group additionally received equipment for self-monitoring of blood glucose and telemedical coaching. Data were collected at baseline, after 6 and 12 months of intervention as well as after a 6-month follow-up. The primary endpoint after 12 months was (i) the estimated treatment difference (ETD) in HbA_1c change and (ii) the HbA_1c normalisation rate in those with diabetes duration < 5 years. The TeLIPro group demonstrated significantly stronger improvements in HbA_1c (ETD −0.4% (−0.5; −0.2); p < 0.001), body weight, body-mass-index, quality-of-life, and eating behaviour, especially in T2DM patients with diabetes duration ≥ 5 years (ETD −0.5% (−0.7; −0.3); p < 0.001). The HbA_1c normalisation rate did not significantly differ between groups (25% vs. 18%). Continuous addition of TeLIPro to routine care is effective in improving HbA_1c and health-related lifestyle in T2DM patients with longer diabetes duration in real life.

Background: The World Health Organization recommends 150 minutes of moderate to vigorous physical activity (PA), which translates to approximately 7000 to 10,000 steps per day for adults. In Germany, less than half of the population in this age range meets this recommendation, highlighting the need for population-based intervention approaches for promoting daily PA. Objective: The complex community-based PA intervention “10,000 Steps Ghent,” which was originally developed in Belgium and was shown to be effective for PA promotion, has been adapted for implementation and evaluation in 2 German cities. The original Belgian study is currently being replicated, and we aim to examine the effectiveness of the adapted intervention among adults living in intervention city districts in Duesseldorf when compared with those living in control city districts in Wuppertal, over the course of 1 year. Methods: A controlled intervention trial examining the effects of an intervention addressing multiple levels (eg, individual level: website; organizational level: PA promotion in companies; community level: media campaigns and environmental changes) is being conducted. PA and various secondary outcomes will be assessed in 2 random samples of adults aged 25 to 75 years (n=399 in each city) at baseline and after 1 year. Results: Funding for this study was obtained in March 2020. Recruitment for this study and baseline data collection were conducted from May 2021 to March 2022 (as of March 2022, 626 participants were enrolled in the study). The intervention will be implemented in Duesseldorf for 1 year from April 2022 onward, and follow-up assessments will be conducted, starting in May 2023 (until September 2023). Data analysis will be performed in fall 2023, and the results will be published in spring 2024. Conclusions: To our knowledge, this is the first research project (currently underway in Germany) that is aimed at replicating the effects of a complex intervention for PA promotion that was previously shown to be effective in another European country. Trial Registration: German Clinical Trials Register DRKS00024873; https://tinyurl.com/4c9e8azh

Background: Most people affected by depression or anxiety disorders are treated solely by their primary care physician. Access to specialized mental health care is impeded by patients’ comorbidity and immobility in aging societies and long waiting times at the providers’ end. Video-based integrated care models may leverage limited resources more efficiently and provide timely specialized care in primary care settings. Objective: The study aims to evaluate the feasibility of mental health specialist video consultations with primary care patients with depression or anxiety disorders. Methods: Participants were recruited by their primary care physicians during regular practice visits. Patients who had experienced at least moderate symptoms of depression and/or anxiety disorders were considered eligible for the study. Patients were randomized into 2 groups receiving either treatment-as-usual as provided by their general practitioner or up to 5 video consultations conducted by a mental health specialist. Video consultations focused on systematic diagnosis and proactive monitoring using validated clinical rating scales, the establishment of an effective working alliance, and a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. Feasibility outcomes were recruitment, rate of loss to follow-up, acceptability of treatment, and attendance at sessions. Effectiveness outcomes included depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), burden of specific somatic complaints (Somatic Symptom Disorder-B Criteria Scale-12), recovery (Recovery Assessment Scale-German [RAS-G]), and perception of chronic illness care (Patient Assessment of Chronic Illness Care), which were measured at baseline and 16 weeks postallocation by assessors blinded to the group allocation. Results: A total of 50 patients with depression and/or anxiety disorders were randomized, 23 in the intervention group and 27 in the treatment-as-usual group. The recruitment yield (number randomized per number screened) and the consent rate (number randomized per number eligible) were 69% (50/73) and 86% (50/58), respectively. Regarding acceptability, 87% (20/23) of the participants in the intervention group completed the intervention. Of the 108 planned video consultations, 102 (94.4%) were delivered. Follow-up rates were 96% (22/23) and 85% (23/27) for the intervention and control groups, respectively. The change from baseline scores at postmeasurement for the No Domination by Symptoms domain of recovery (RAS-G) was somewhat higher in the intervention group than in the control group (Mann-Whitney U test: rank-biserial r=0.19; 95% CI −0.09 to 0.46; P=.18). We did not detect any notable differences between the intervention and control groups in terms of other effectiveness outcomes. We did not observe any serious adverse events related to the trial. Conclusions: The intervention and study procedures were found to be feasible for patients, primary care practice staff, and mental health specialists. A sufficiently powered pragmatic trial on mental health specialist video consultations should be conducted to investigate their effectiveness in routine care. Trial Registration: German Clinical Trials Register DRKS00015812; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015812.

Introduction Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS. Methods and analysis A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses. Ethics and dissemination The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars. Trial registration number ClinicalTrials.gov Registry (NCT03968172); Pre-results.