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Design of a Mobile Application and a Clinical Trial Management System for Cognitive Health: Empowering a Digital Intervention for Dementia Risk Reduction
Hannes Hilberger;
Bianca Buchgraber-Schnalzer;
Simone Huber;
Theresa Weitlaner;
Markus Bödenler;
Alara Abaci;
Jeroen Bruinsma;
Ana Diaz;
Anna Giulia Guazzarini;
Jenni Lehtisalo;
Seungjune Lee;
Vasileios Loukas;
Francesca Mangialasche;
Patrizia Mecocci;
Tiia Ngandu;
Anna Rosenberg;
Elisabeth Stögmann;
Konsta Valkonen;
Elena Uhlik;
Helena Untersteiner;
Laura Kneß;
Helmut Ahammer;
Sten Hanke
ABSTRACT
Background:
The rising prevalence of dementia is a major concern, with about 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 factors 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 application for study participants and a clinical trial management system (CTMS) for health professionals.
Methods:
Utilizing 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 RCT evaluating the feasibility of a digitally supported lifestyle program for dementia risk reduction. The RCT is currently ongoing; the SUS was administered one month after baseline to map first user experiences. Feedback on the LETHE CTMS was collected from 21 users.
Results:
Among the 78 participants in the trial intervention group, 66 responses were received for the mobile application with a median SUS score of 70 (IQR 55-82). Within the control group, 57 responses were received with a median SUS of 73 (IQR 63-90). For the CTMS, we received 15 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 findings. Despite these limitations, positive feedback and usability scores suggest promising potential for the LETHE App and CTMS in supporting personalized interventions to prevent cognitive decline in older adults. Clinical Trial: ClinicalTrials.gov NCT05565170; https://clinicaltrials.gov/study/NCT05565170
Citation
Please cite as:
Hilberger H, Buchgraber-Schnalzer B, Huber S, Weitlaner T, Bödenler M, Abaci A, Bruinsma J, Diaz A, Guazzarini AG, Lehtisalo J, Lee S, Loukas V, Mangialasche F, Mecocci P, Ngandu T, Rosenberg A, Stögmann E, Valkonen K, Uhlik E, Untersteiner H, Kneß L, Ahammer H, Hanke S
Design of a Mobile App and a Clinical Trial Management System for Cognitive Health and Dementia Risk Reduction: User-Centered Design Approach