Web-based lifestyle interventions have attracted considerable research interest. Available evidence on such interventions suggests health-promoting effects, but further research is needed. Therefore, this study aims to investigate short-, medium-, and long-term health effects of a web-based health program (“TK-HealthCoach”, TK-HC) offered by a national statutory health insurance fund (Techniker Krankenkasse, TK). The study comprises two randomized controlled clinical trials to evaluate the health goals “Increasing Fitness” (Fclin) and “Losing and Maintaining Weight” (Wclin). A total of n = 186 physically inactive (Fclin) and n = 150 overweight or obese (Wclin) adults will be randomly assigned to a 12-week interactive (TK-HC) or non-interactive web-based health program using permuted block randomization with a 1:1 allocation ratio. Primary outcomes include cardiorespiratory fitness (Fclin) and body weight (Wclin). Secondary outcomes comprise musculoskeletal fitness (Fclin), physical activity and dietary behavior, anthropometry, blood pressure, blood levels, and vascular health (Fclin, Wclin). All outcomes will be measured before and after the 12-week intervention and after a 6- and 12-month follow-up. Additionally, usage behavior data on the health programs will be assessed. Linear mixed models (LMMs) will be used for statistical analysis. Findings of this study will expand the available evidence on web-based lifestyle interventions.
BackgroundCough is one of the most common symptoms in general and pulmonary medicine with profound negative impact on health-related quality of life (HRQL). The Leicester Cough Questionnaire (LCQ) is a validated HRQL questionnaire, yet a validated German version of the LCQ is not available and it has never been tested in a cohort with sarcoidosis.ObjectivesTo translate the LCQ into German and determine its psychometric properties.MethodsThe LCQ was translated in a forward-backward approach. Structured interviews in sarcoidosis patients were performed. Subsequently, sarcoidosis patients were asked to answer the German LCQ and comparative questionnaires. Distribution properties, item difficulty, concurrent validity, Rasch model fit and internal consistency of the German LCQ were determined.Results200 patients with sarcoidosis were included. We provide evidence for reliability, unidimensionality and internal consistency. However, only a moderate correlation with general and respiratory-specific HRQL questionnaires, no Rasch model fit could be shown. Skewed responses caused by floor effects were detected.ConclusionWe demonstrate that the German LCQ is valid and reliable and its psychometric properties fulfil the standards required for its use in clinical settings as well as in interventional trials.
Die Kooperation von Hausärzten mit ambulant und stationär tätigen Spezialisten ist in der Versorgung bei psychischen Störungen von zentraler Bedeutung. Empirische Studien zum aktuellen Kooperationsgeschehen fehlen. Ziel war die Analyse der Zusammenarbeit von hausärztlichen, fachärztlichen und psychologisch-psychotherapeutischen Behandlern in der ambulanten und stationären Versorgung. Methode: Mittels eines Online-und postalischen Fragebogens wurden Kooperationsformen, Probleme in der Kooperation, Kooperationsbedarf, Zufriedenheit und Verbesserungsvorschläge zur Vernetzung erhoben. Ergebnisse: Insgesamt füllten N = 504 Behandler den Fragebogen aus, darunter 108 Hausärzte, 96 ambulant und 63 stationär tätige Fachärzte sowie 216 ambulant und 21 stationär tätige psychologische Psychotherapeuten. Kooperation findet in erster Linie bei Bedarf im Einzelfall statt und basiert nur wenig auf festgelegten Strukturen und definierten Routinen. Obwohl sich die Teilnehmenden relativ zufrieden mit der aktuellen Kooperation zeigen, ist der wahrgenommene Bedarf an Kooperation groß. Schwierigkeiten werden v.a. aufgrund von fehlenden ambulanten Therapieplätzen, Zeitmangel, Problemen bei der Erreichbarkeit von Kollegen und wenig etablierten Kooperationsprozessen gesehen. Implikationen: Die Behandler sind grundsätzlich zufrieden, sehen aber dennoch Verbesserungsbedarf bei der Vernetzung der psychischen Versorgung. Daher ist die Optimierung entsprechender Strukturen und Prozesse mit dem Ziel der Verbesserung der patientenorientierten Behandlung von Menschen mit psychischen Störungen notwendig.
Background Urinary stone disease is a widespread disease with tremendous impact on those affected and on societies around the globe. Nevertheless, clinical and health care research in this area seem to lag far behind cardiovascular diseases or cancer. This may be due to the lack of an immediate deadly threat from the disease and therefore less public and professional interest. However, the patients suffer from recurring, sometimes intense pain and often must be treated in hospital. Long-term morbidity includes doubled rates of chronic kidney disease and arterial hypertension after at least one stone-related event. Observational studies, more specifically, registries and other electronic data sets have been proposed as a means of filling critical gaps in evidence. We propose a nationwide digital and fully automated registry as part of the German Ministry for Education and Research (BMBF) call for the "establishment of model registries”. Methods RECUR builds on the technical infrastructure of Germany’s Medical Informatics Initiative. Local data integration centres (DIC) of participating medical universities will collect pseudonymized and harmonized data from respective hospital information systems. In addition to their clinical data, participants will provide patient reported outcomes using a mobile patient app. Scientific data exploration includes queries and analysis of federated data from DICs of eleven participating sites. All primary patient data will remain at the participating sites at all times. With comprehensive data from this longitudinal registry, we will be able to describe the disease burden, to determine and validate risk factors, and to evaluate treatments. Implementation and operation of the RECUR registry will be funded by the BMBF for five years. Subsequently, the registry is to be continued by the German Society of Urology without significant costs for study personnel. Discussion The proposed registry will substantially improve the structural and procedural framework for patients with recurrent urolithiasis. This includes advanced diagnostic algorithms and treatment pathways. The registry will help us identify those patients who will most benefit from specific interventions to prevent recurrences. The RECUR study protocol and the registry’s technical architecture including full digitalization and automation of almost all registry-associated proceedings can be transferred to future registries. Trial registration This study is registered at the German Clinical Trial Register (Deutsches Register Klinischer Studien), DRKS-ID DRKS00026923, date of registration January, 11th 2022.
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