IntroductionGeneral practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients.Methods and analysisThe BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points.Ethics and disseminationResearch ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients.Trial registration numbersDRKS00028805,NCT05667207.
Background Asthma education programs (AEPs) have been shown to increase quality of life and reduce emergency treatments and hospital admissions. Despite the proven benefits, only a minority of asthma patients attend such programs. To increase the number of educated patients, an online education program (electronic AEP, eAEP) for asthma patients has been developed. The present study aims to investigate the effectiveness of the eAEP in terms of asthma knowledge, asthma control and emergency treatments in general practice settings. Methods This is a cluster randomized controlled trial including 100 patients with bronchial asthma from 20 general practices in Bavaria, Germany. General practices will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive access to the eAEP and instructions to complete this program within two weeks. Patients in the control group will receive usual care including a referral to face-to-face AEP (fAEP) by a certified primary care physician or a pulmonologist according to guideline recommendations. Furthermore, patients of both the intervention and control groups will be invited to a follow-up consultation in their general practice after completion of the eAEP and fAEP (three weeks and twelve weeks after study inclusion, respectively) to discuss any open issues. Outcomes for both groups will be assessed at baseline (t0), after two weeks (t1), three months (t2) and six months (t3). The primary outcome is the comparison of asthma knowledge gain between intervention and control groups after completion of the eAEP (two weeks after study inclusion) and fAEP (twelve weeks after study inclusion), respectively. Secondary outcomes include asthma control, frequency of emergency treatments, patient autonomy as well as attitudes towards asthma medication. Discussion The results of the present trial will provide knowledge about the effectiveness of an online education program for asthma patients compared to usual care in primary care. Trial registration German Clinical Trials Register (DRKS), DRKS00028805. Registered 22 April 2022.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.