Clinical trials

The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care. The main question the study aims to answer is: Does a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care? Researchers will compare peer-mentor support plus usual care with usual care alone. Participants will: Complete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks. Be randomized either to receive peer-mentor support for 16 weeks or to receive usual care only. If allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period. The study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.

Objective of the study: The primary aim of this study is to evaluate the feasibility of a proposed intervention designed to support the daily movement practices and fostering joy of movement in Danish kindergartens, as well as the implementation strategies intended to facilitate adoption. Additionally, the feasibility of the planned measurement and procedures for a future effectiveness study will be examined. Methods: The study uses a mixed-methods design to examine the feasibility of the intervention and the future evaluation design. The planned duration of the intervention period is 10 weeks. The intervention consists of multiple integrated components co-designed with pedagogical staff, leaders, experts in kindergarten movement culture, and a team of researchers, to collectively support the daily movement practice in kindergartens. Alongside the intervention components, tailored strategies are developed to facilitate adoption and implementation. The intervention elements are categorized into four main types: 1) Formal establishment of the project; 2) Components of physical activity integrated in existing structures in the kindergarten; 3) Organizational and staff training; 4) Inspirational materials, tools and exemplary plans. The use of a co-design approach in close collaboration between kindergartens, experts, and a team of researchers will ensure contextual relevance and shared ownership. This approach is expected to enhance acceptability, feasibility, and sustainability of the intervention. The mixed-methods evaluation design, use of theoretical implementation frameworks, and tailored strategies further strengthen the study. The findings from this feasibility study will inform the refinement of the final intervention and guide the planning of a forthcoming effectiveness study.