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Randomized Controlled Trial
. 2025 Jul 2:8:e66660.
doi: 10.2196/66660.

Design of a Mobile App and a Clinical Trial Management System for Cognitive Health and Dementia Risk Reduction: User-Centered Design Approach

Hannes Hilberger  1   2 , Bianca Buchgraber-Schnalzer  1 , Simone Huber  1 , Theresa Weitlaner  1 , Markus Bödenler  1 , Alara Abaci  3 , Jeroen Bruinsma  4 , Ana Diaz  5 , Anna Giulia Guazzarini  6   7 , Jenni Lehtisalo  8 , Seungjune Lee  9   10 , Vasileios Loukas  11   12 , Francesca Mangialasche  3   13 , Patrizia Mecocci  6   7 , Tiia Ngandu  3   8   14 , Anna Rosenberg  3   8 , Elisabeth Stögmann  9   10 , Konsta Valkonen  8   15 , Elena Uhlik  9   10 , Helena Untersteiner  9   10 , Laura Kneß  1 , Helmut Ahammer  2 , Sten Hanke  1
Affiliations
Randomized Controlled Trial

Design of a Mobile App and a Clinical Trial Management System for Cognitive Health and Dementia Risk Reduction: User-Centered Design Approach

Hannes Hilberger et al. JMIR Aging. .

Abstract

Background: The rising prevalence of dementia is a major concern, with approximately 45% of cases linked to 14 modifiable risk factors. The European project LETHE aims to develop a personalized digital intervention model to delay or prevent cognitive decline through risk factor management.

Objective: The objective of our study was to design a clinical trial platform for older individuals at risk of cognitive decline, including a mobile app for study participants and a clinical trial management system (CTMS) for health professionals.

Methods: Using a user-centered design approach, workshops and feedback rounds involved potential participants representing the target group and professionals. The LETHE app's usability was assessed among 156 older adults enrolled in a 2-year multinational randomized controlled trial evaluating the feasibility of a digitally supported lifestyle program for dementia risk reduction. The randomized controlled trial is currently ongoing; the System Usability Scale (SUS) was administered 1 month after baseline to map first user experiences. Feedback on the LETHE CTMS was collected from 21 users.

Results: Of the 78 participants in the trial intervention group, 66 (85%) provided responses for the mobile app, with a median SUS score of 70 (IQR 55-82). Within the control group, 73% (57/78) of responses were received, with a median SUS score of 73 (IQR 63-90). For the CTMS, we received 71% (15/21) of responses, and the feedback was mostly positive. A ranking of the features that could be considered beyond state of the art showed that the integration of personalized activities (mean 2.23, SD 1.17) and real-time appointments (mean 2.46, SD 1.51) were considered the most novel ones.

Conclusions: The LETHE app and CTMS were developed to support a personalized digital intervention method within a study involving 156 participants. Limitations include participants having digital literacy and internet access, potentially impacting the generalizability of the findings. Despite these limitations, positive feedback and high usability scores suggest promising potential for the LETHE app and CTMS in supporting personalized interventions to prevent cognitive decline in older adults.

Keywords: AI; artificial intelligence; clinical trial; cognitive decline; dementia; eHealth; health information systems; mHealth; medical informatics; mobile apps; mobile health; multidomain interventions; prevention.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Different phases for the design and development of the LETHE app and LETHE clinical trial management system (CTMS).
Figure 2
Figure 2
Categorized and ranked requirements for the LETHE app. GP: general practitioner.
Figure 3
Figure 3
Overview of the modules, functionalities, and interactions between the LETHE app and the LETHE clinical trial management system (CTMS).
Figure 4
Figure 4
Comparison between in-person and digital components for each lifestyle domain.
Figure 5
Figure 5
System Usability Scale (SUS) responses for the LETHE app in the intervention group. Panel (A) shows positively formulated questions, whereas panel (B) highlights negatively formulated questions. Green indicates high user satisfaction, and red indicates low user satisfaction. Q: question.
Figure 6
Figure 6
Box plot of the System Usability Scale (SUS) scores for each country in the intervention group.
Figure 7
Figure 7
System Usability Scale (SUS) responses for the LETHE app in the control group. Panel (A) shows positively formulated questions, whereas panel (B) highlights negatively formulated questions. Green indicates high user satisfaction, and red indicates low user satisfaction. Q: question.
Figure 8
Figure 8
Box plot of the System Usability Scale (SUS) scores for each country in the control group.
Figure 9
Figure 9
Survey responses for the LETHE clinical trial management system from health professionals. Green indicates high user satisfaction, and red indicates low user satisfaction.
See this image and copyright information in PMC

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