Evidence map›Paper›PMID 40601924›Full record

Trial reportJMIR aging2025

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

Hannes Hilberger, Bianca Buchgraber-Schnalzer, Simone Huber, Theresa Weitlaner, Markus Bödenler, Alara Abaci, Jeroen Bruinsma, Ana Diaz, Anna Giulia Guazzarini, Jenni Lehtisalo and 13 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in JMIR aging, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Hannes HilbergerInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0000-0003-3867-0651
Bianca Buchgraber-SchnalzerInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0009-0003-8709-0108
Simone HuberInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0000-0002-8555-084X
Theresa WeitlanerInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0009-0005-7076-2929
Markus BödenlerInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0000-0001-6018-7821
Alara AbaciDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0009-0001-9545-1861
Jeroen BruinsmaDepartment of Health Promotion, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.ORCID https://orcid.org/0000-0002-7964-0267
Ana DiazAlzheimer Europe, Luxembourg, Luxembourg.ORCID https://orcid.org/0000-0002-5533-0344
Anna Giulia GuazzariniDivision of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.ORCID https://orcid.org/0000-0001-5071-4624
Jenni LehtisaloLifestyles and Living Environments Unit, Department of Public Health, Finnish Institute for Health and Welfare, Helsinki, Finland.ORCID https://orcid.org/0000-0002-8818-0848
Seungjune LeeDepartment of Neurology, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0009-0009-5378-7832
Vasileios LoukasDepartment of Materials Science and Engineering, Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, Ioannina, Greece.ORCID https://orcid.org/0000-0001-6390-884X
Francesca MangialascheDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-2686-3926
Patrizia MecocciDivision of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.ORCID https://orcid.org/0000-0003-0729-5246
Tiia NganduDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0002-3698-2021
Anna RosenbergDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0003-1456-7991
Elisabeth StögmannDepartment of Neurology, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0000-0003-4688-8482
Konsta ValkonenLifestyles and Living Environments Unit, Department of Public Health, Finnish Institute for Health and Welfare, Helsinki, Finland.ORCID https://orcid.org/0009-0000-9099-5889
Elena UhlikDepartment of Neurology, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0009-0002-7563-406X
Helena UntersteinerDepartment of Neurology, Medical University of Vienna, Vienna, Austria.ORCID https://orcid.org/0009-0004-5015-4718
Laura KneßInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0009-0009-9599-3845
Helmut AhammerGottfried Schatz Research Center, Division of Medical Physics and Biophysics, Medical University of Graz, Graz, Austria.ORCID https://orcid.org/0000-0001-5400-294X
Sten HankeInstitute of eHealth, University of Applied Sciences - FH JOANNEUM, Graz, Austria.ORCID https://orcid.org/0000-0003-3833-4252

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectiveThe 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.

methodsUsing 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.

resultsOf 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.

conclusionsThe 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.

Indexed as

Cognitive DysfunctionDementiaMobile ApplicationsRisk Reduction BehaviorUser-Centered DesignAgedAged, 80 and overCognitionFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicAIartificial intelligenceclinical trialcognitive declinedementiaeHealthhealth information systemsmedical informaticsmHealthmobile appsmobile healthmultidomain interventionsprevention

Identifiers

PMID40601924
PMCPMC12268216

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.