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EFFET - Study of Executive Functions Regarding the Usability and User Experience of Assistive Technologies Among the Elderly (EFFET)

16 septembre 2026 mis à jour par: University Hospital, Angers

EFFET - Study of Executive Functions Regarding the Usability and User Experience of Assistive Technologies Among the Elderly / Etude Des Fonctions Exécutives Sur l'utilisabilité et l'expérience Utilisateur Des Technologies d'Assistance Chez Les Personnes âgées

Population aging increases the strain on healthcare systems and highlights the value of gerontechnologies in promoting the autonomy and home-based living of older adults. However, their adoption remains limited, particularly due to age-related cognitive changes.

Cognitive Load Theory attributes certain difficulties in using digital technologies to the excessive demands placed on working memory. Yet, it provides limited insight into the executive functions involved in interface interaction-specifically inhibition, cognitive flexibility, and working memory updating. The concept of "executive load" may therefore provide a framework for examining examine how excessive demands on these functions affect user efficiency.

The primary objective of this study is to evaluate the impact of mental flexibility on the usability of a digital interface among individuals aged 65 or older living in senior residences who have an MMSE score of ≥ 24/30. Executive functions, cognitive reserve, technology acceptance, and digital skills are assessed during an initial visit.

Between 24 hours and one month later, participants perform a medical appointment-booking task on a tablet twice, using two interfaces that differ in executive load (low versus high). The order of interface presentation is randomized to control for potential order and practice effects. Performance, user experience, and cognitive load are recorded after each task.

The study aims to recruit 70 participants to obtain at least 50 complete datasets. Although the study offers no direct therapeutic benefit, it is expected to help better tailor gerontechnologies to the cognitive capabilities of older adults and facilitate the design of more accessible and inclusive digital interfaces, particularly in the healthcare sector.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
    • Maine Et Loire
      • Angers, Maine Et Loire, France, 49000
      • Angers, Maine Et Loire, France, 49100
      • Angers, Maine Et Loire, France, 49100

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Be aged 65 or older
  • Reside in a partner senior living facility
  • Understand French
  • Have signed an informed consent form for participation
  • Be affiliated with or a beneficiary of a social security scheme
  • Present an MMSE (Mini-Mental State Examination) score of ≥ 24/30

Exclusion Criteria:

  • Be subject to a legal protection measure
  • Have a major, uncorrected visual or hearing impairment preventing the reading of questionnaires, the completion of neuropsychological tests, or the use of a touchscreen tablet
  • Have a motor impairment of the upper limbs making the use of a touchscreen tablet impossible
  • Have a neurological or psychiatric condition likely to impair executive functions or participation in the assessment, including acute or progressive neurological disorders, significant neurological history, and unstabilized psychiatric disorders

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: High-executive-load task first

Participants realise high-executive-load task and then low-executive-load task
Autre: high executive load task

high executive load task

Autre: low executive load task

low executive load task
Autre: low-executive-load task first

Participants realise low-executive-load task and then high-executive-load task
Autre: high executive load task

high executive load task

Autre: low executive load task

low executive load task

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Correlation between Trail Making Test Z-score and usability score (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of mental flexibility on the usability of a digital interface

=> correlation between the Trail Making Test Z-score and the usability score (completion time in seconds) for the digital task under low executive load conditions.

The Trail Making Test consists of two sheets (A and B). On sheet A, the participant must connect numbers in ascending order (time and number of errors are recorded). On sheet B, the participant must alternate between connecting numbers and letters (time, number of errors, and number of perseverations are recorded). A Z-score is calculated using the recorded scores.
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between Trail Making Test Z-score and UEQ score (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of mental flexibility on user experience

=> correlation between the Trail Making Test Z-score and the UEQ score under conditions of low executive load.

UEQ (26 items) : a questionnaire evaluating user experience across six dimensions: attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty. These dimensions can be grouped into two subscales: pragmatic (efficiency, clarity, dependability) and hedonic (stimulation and novelty). Each item is rated on a scale of 1 to 7, with results converted into composite scores. A score close to +3 indicates a very positive experience, while a score close to -3 indicates a negative experience. The score for each UEQ dimension will be recorded. The questionnaire is administered via interviewer-led assessment (taking approximately 15 minutes).
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
Correlation between Victoria Stroop Z-score and usability score (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of inhibition on usability

=> correlation between the Victoria Stroop Z-score and the usability score (completion time in seconds) under low executive load conditions.

The Victoria Stroop test consists of three cards (color, word, and interference). On the color card, participants must name the color of 24 colored circles (time, corrected errors, uncorrected errors, and total errors are recorded). On the word card, they must read 24 words printed in colored ink (time, corrected errors, uncorrected errors, and total errors are recorded). On the interference card, they must name the ink color of 24 words denoting a different color (e.g., the word "red" printed in yellow ink); time, corrected errors, uncorrected errors, and total errors are recorded. A Z-score is calculated based on the recorded scores.
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
Correlation between Victoria Stroop Z-score and UEQ score (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of inhibition on the user experience

=> correlation between the Victoria Stroop Z-score and the UEQ score under low executive load conditions.
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
Correlation between 2-back and usability scores (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of the update on usability

=> correlation between the 2-back d'score and the usability score (completion time in seconds) under low executive load conditions.

The 2-back task involves presenting a series of 30 letters one by one. For each letter presented, the participant must indicate-by pressing a keyboard key-whether it is identical to the letter presented two items previously. It yields five metrics: the number of correctly detected targets, false alarms, missed targets, correctly rejected targets, and the d-prime (d') score. The d' score is used as the primary metric.
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
Correlation between 2-back and the UEQ scores (low executive load)
Délai: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Evaluate the impact of the update on the user experience

=> correlation between the 2-back d'score and the UEQ score under low executive load conditions.
Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
MDPQ-16 score
Délai: Visit 1 (48 hours to 15 days after informing the participants)

Describe the participants' level of digital skills (control variable)

=> score on the MDPQ-16 questionnaire. Technological skills will be measured using the Mobile Device Proficiency Questionnaire (MDPQ-16), which assesses proficiency in using mobile devices (smartphones and tablets) among older adults. The MDPQ-16 questionnaire consists of 16 items rated on a 5-point Likert scale ranging from 1 ("Never done") to 5 ("Very easily"), with a maximum total score of 80. It is administered via interviewer assessment (taking approximately 5 minutes), and the score for each Likert scale item is recorded.
Visit 1 (48 hours to 15 days after informing the participants)
CRI-q score
Délai: Visit 1 (48 hours to 15 days after informing the participants)

Describe the participants' level of cognitive reserve (control variable)

=> score on the CRI-q questionnaire. CRI-q questionnaire evaluates four dimensions: CRI Total, CRI Education, CRI Work, and CRI Leisure. Responses to each item will be recorded. Each dimension yields a standardized score, calculated using an Excel file provided by the authors. This questionnaire is normed for ages up to 102. It is administered via interviewer assessment (taking approximately 15 minutes).
Visit 1 (48 hours to 15 days after informing the participants)
STAM score
Délai: Visit 1 (48 hours to 15 days after informing the participants)

Describe the participants' level of technology acceptance (control variable)

=> score on the STAM questionnaire. Attitudes toward technology will be measured using the S-STAM (Short-Senior Technology Acceptance Model), a 14-item questionnaire covering four dimensions: attitudes (3 items), control (4 items), anxiety (2 items), and health (5 items). Each item is rated on a Likert scale from 1 to 10. The maximum score is 140. Scores for each Likert scale are recorded. Developed for older adults, it is administered via interviewer assessment (taking approximately 10 minutes).
Visit 1 (48 hours to 15 days after informing the participants)
Usability score (low vs. high executive load)
Délai: Visit 2 (24 hours to 1 month after visit 1)

Compare the usability score between the low executive load interface and the high executive load interface

=> comparison of the usability score (completion time in seconds) between the two experimental conditions (low vs. high executive load).
Visit 2 (24 hours to 1 month after visit 1)
User experience score (low vs. high executive load)
Délai: Visit 2 (24 hours to 1 month after visit 1)

Compare the user experience score between the low executive load interface and the high executive load interface

=> comparison of the UEQ score between the two experimental conditions (low vs. high executive load).
Visit 2 (24 hours to 1 month after visit 1)
Perceived cognitive load score (low vs. high executive load)
Délai: Visit 2 (24 hours to 1 month after visit 1)

Compare the perceived cognitive load score between the low executive load interface and the high executive load interface

=> comparison of the perceived cognitive load score between the two experimental conditions (low vs. high executive load).
Visit 2 (24 hours to 1 month after visit 1)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Angers

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

15 mai 2028

Dates d'inscription aux études

Première soumission

8 septembre 2026

Première soumission répondant aux critères de contrôle qualité

16 septembre 2026

Première publication (Réel)

22 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2026-A01625-46

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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