Feasibility, use and usability of an adapted mHealth tool for dementia risk reduction among middle-aged and older...

Several potentially modifiable factors are associated with the risk of cognitive decline and dementia, indicating potential for risk reduction via lifestyle modifications. While multidomain interventions targeting lifestyle changes for dementia risk reduction are often highly selective and resource-intensive, eHealth/mHealth interventions offer a potentially low-cost, scalable approach to promote brain-healthy lifestyles for a large number of individuals. This protocol outlines a pilot study to test an mHealth intervention for dementia risk reduction among middle-aged to older adults in Germany.

We will translate and adapt the smartphone-based intervention MyBraincoach for dementia risk reduction, developed at Maastricht University in the Netherlands, to the German healthcare setting and test the app in a 12-week, non-randomised pre-post pilot study. Key feasibility outcomes include feasibility and success of recruitment, use and usability of the app. Exploratory outcomes include changes in dementia risk profiles, dementia literacy, health-related quality of life, self-efficacy and motivation for behaviour change. A sample of n=75 adults aged 40-75 years will be recruited across Germany, using diversified convenience sampling. Data will be collected using web-based questionnaires at baseline and follow-up after 12 weeks. Feasibility and success of recruitment, including recruitment rates and sample characteristics, will be evaluated descriptively. Changes in dementia risk profiles and other secondary outcomes will be investigated using dependent-samples t-tests and McNemar's tests as appropriate. Lastly, a moderated remote focus group will be conducted with n=8 participants of the pilot study to gain insights on the target group's experiences with usage of the app and to assess suggestions for modification and improvement. Respective data will be analysed using structured content analysis.

Ethical approval was obtained from the Ethics Committee of the Medical Faculty of Leipzig University (ref.: 476/22-ek). Findings will be disseminated via peer-reviewed publications, presentation at (inter)national scientific conferences and social media channels, respectively. Results will inform design and sample size of a confirmatory randomised controlled trial to assess effectiveness of the intervention.

German Clinical Trials Register (DRKS00038349).