This report focuses on identifying and implementing simple and robust low-level statistics and visualizations for data collected via the DMMH app. Statistics and visualizations were selected based on providing a specific application in a clinical setting and technical feasibility. Advanced statistical analyses such as ARMA models and models of mutual predictability were discussed but discarded due to concerns regarding interpretation difficulties on the clinical side. The pooling of data across subjects was also discontinued due to data privacy concerns.
In this report, we describe IMMERSE Phase I, an extensive qualitative study consisted of two parts, a survey study (Part A) and an interview study (Part B). We outline the design of each part, discuss how the data were collected and prepared for further scientific analysis, and present preliminary findings that are relevant for the implementation of IMMERSE Phase II, a cluster randomised clinical trial of DMMH. We end with a summary of lessons learned for Phase II.
This report details the development of the DMMH intervention and the strategies to implement it across various sites. This was done in close collaboration with other work packages, and the strategies were informed by the research from phase 1. The strategies were further optimized and adapted to the needs of each participating site, and the WP7 members were trained to deliver them in the cluster randomized controlled trial.
This report is about achieving ethical approval. The research was planned and the Clinical Investigation Plan (CIP) was written, reviewed, and approved by members of WP7, and registered in the ISRCTN trial register. The CIP and further study documents were submitted to local ethics committees and competent authorities in all participating sites, with all sites receiving approval. The successful deliverable was the result of close collaboration between consortium members and clinical investigation sites.
This project has received funding from the European Union’s Horizon 2020 research and innovation Programme under grant agreement 945263 (IMMERSE). This website reflects only the authors' view and the European Commission is not responsible for any use that may be made of the information it contains