¹German Center for Neurodegenerative Diseases (DZNE), site Rostock/Greifswald, Greifswald, Germany
²Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany
³Psychological Aging Research (PAR), Department of Psychology, University of Siegen, Siegen, Germany

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Introduction: The DECIDE-2 project [1] aims to increase the autonomy of people with dementia and reduce the burden of relatives and caregivers. This shall be achieved by integrating Advance Care Decision Making (ACD) into the evidence-based concept of Dementia Care Management (DeCM). The ACD-DeCM approach will be adapted for dementia care practice in a participatory process. Its effectiveness will be evaluated in a randomised controlled single-blind study.

DECIDE-2 has project-specific requirements regarding data collection, aiming to make it as efficient as possible while obtaining high-quality data. Its requirements for an eCRF software solution (electronic Case Report Form) include:

• Study staff creates and maintains forms (eCRF)
• Scientists can export data (e.g. in .csv) independently
• Five users may use the eCRF-solution simultaneously
• Offline (server unavailable) and online use (browser on server) are possible (reliable internet connections are not always available on site)
• Predefined rules trigger demands (support and care measures for PWD or their relatives), processed by the study staff.

The software re:forms [2] can implement the individual research project ́s requirements. It will be evaluated for collecting person identifying data and medical data based on project requirements. This aims to check the re:forms suitability and to test the software in practical use.

Methods: A test infrastructure was set up for trial operation of re:forms. The project staff was trained to use re:forms via video conference for approximately 60 minutes, covering ‘data collection’ and ‘eCRF design‘. Project-specific requirements and suggestions for UI and technical optimisations were identified by study staff and scientists (e.g. patient-specific custom notes) the eCRF-solution. Software developers implemented these improvements into the current version of re:forms. During the test phase, form-design, data collection and offline/online data synchronisation processes were tested. However, no productive data was gathered.

Results: The DECIDE-2 project ́s evaluation helped increasing re:forms software quality and improve its usability during the pilot phase. DECIDE-2 benefits equally from those improvements. The 46 forms designed in the test phase will likely be used in production, too. The project requirements were realised through the use of re:forms.

Discussion: Integrating re:forms into DECIDE-2 at an early project stage and adapting to scientists' project-specific requirements made its test phase successful. Although its application in practice is still pending, it has already been shown that re:forms is suitable for application in other projects.

While productive use often presents challenges, the DECIDE-2 team remains optimistic based on their experience. They preferred using re:forms online, with only a few cases having meaningful data for parallel offline use. Despite being ready for productive use, re:forms is still officially in its pilot phase. The software advances constantly by the Institute for Community Medicine.

Conclusion: Generally, re:forms meets the requirements and represents a potentially suitable software solution for DECIDE-2. It focusses on form-design and maintenance by project staff, the combination of online/offline data collection, and corresponding synchronisation processes. However, a final statement on the successful introduction of re:forms is anticipated. The practical phase starting in April 2025 will certainly present challenges in the daily data collection routine.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.

References

[1] Bundesministerium für Bildung und Forschung. DECIDE 2: Entscheidungsassistenz bei gesundheitlicher Vorausplanung für Menschen mit Demenz. Berlin: Bundesministerium für Bildung und Forschung; [cited 2025 Apr 8]. Available from: https://www.gesundheitsforschung-bmbf.de/de/decide-2-entscheidungsassistenz-bei-gesundheitlicher-vorausplanung-fur-menschen-mit-demenz-17996.php
[2] Institut für Community Medicine. re:forms - Formulare (eCRFs) neu gedacht. Greifswald: Peter Penndorf; 2025 [cited 2025 Apr 8]. Available from: https://re-forms.de