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IntroductionCardiovascular diseases are the most common cause of death in Germany and among the most frequent reasons for encounters in primary care. Most patients with cardiovascular risks (CVRs) have difficulties implementing health-promoting behavioural changes. In this study, a complex intervention containing evidence-based patient materials and structured follow-up consultations are intended to strengthen patients’ self-management to improve health behaviour.Methods and analysisIn this cluster randomised controlled trial, we investigate the effects of the intervention "Decision aid, action planning and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases" (DECADE) using a 2×2 design. All patients, including the control group (CG), receive a CVR calculation. Three intervention groups (IGs) receive one or both of two different components of the DECADE intervention: IG1 (patient materials), IG2 (follow-up consultations) and IG3 (patient materials and follow-up consultations). The study was planned to be conducted with 77 general practitioners in 3 German regions and a target sample size of 924 patients. The observation period for each patient amounts to 12 months with three patient surveys: baseline (t0), after 6 and 12 months (t1 and t2). The primary outcome is patient activation (Patient Activation Measure 13 (PAM13-D)) at t1. Secondary outcomes include PAM13-D at t2 and further patient-reported and clinical outcomes at t1 and t2. We will also analyse the cost-effectiveness of the intervention, the degree of usage and satisfaction with the intervention.Ethics and disseminationThe study was first approved by the lead ethics committee of the University of Freiburg on 15 April 2021 (vote number: 21-1078) and subsequently by the other ethics committees in the study regions (Ethics committee of medical association Baden-Württemberg (B-F-2021-078), Ethics Committee of the Technische Universität Dresden, Dresden (BO-EK-251052021), Ethics Committee of the State Chamber of Physicians of Saxony (EK-BR-92/21-1), Ethics Committee of the Hamburg Medical Association (2021-200013-BO-bet)). Informed consent is required for patients to participate in the study. The results of this study will be published in peer-reviewed journals and presented at congresses by the DECADE team. The DECADE lead management will communicate the results to the funder of this study.Trial registration numberGerman Clinical Trials Register, DRKS00025401 (registration date: 21 June 2021); International Clinical Trials Registry Platform, DRKS00025401.

Introduction Medical care of homebound patients by home visits is an integral part of primary care in Germany and other industrialised countries. Owing to the sociodemography and changes in the health system, the need for home visits is projected to increase rather than decrease. Our study will provide information on content and organisation of home visits. This evidence is needed to assure sufficient medical care for homebound patients. Germany is one of the European nations with highest proportions of elderly age groups, so that our results will be indicative for other European countries with comparable organisation of primary care. Methods and analysis This cross-sectional study is conducted over a period of 12 months. All home visits of each participating family practice are documented within a 1-week time period. The anonymous documentation of home visits is carried out by the family practitioner or medical assistant conducting the home visit. All Saxon Family practitioners received study information and were personally invited to participate in our study. Almost 303 (of 2677) family practitioners expressed their interest to participate to generate data on the content and organisational characteristics of home visits. Data analysis of more than 4000 home visits will take into account several patient-related and system-related parameters. Descriptive and multivariate analysis will be carried out by using non-parametric methods. Regarding expected cluster structure of the data, a multilevel analysis will be necessary. Ethics and dissemination The study received ethical approval by the Ethical Commission of the TU Dresden and adheres to the Declaration of Helsinki. Considering that the results of our project will be indicative for ageing societies with comparable organisation of primary care, we will publish them in international open access journals concerned with healthcare and primary care research and disseminate them by a final symposium and at national/international scientific events.