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

16 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: High-executive-load task first

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

high executive load task

Ander: low executive load task

low executive load task
Ander: low-executive-load task first

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

high executive load task

Ander: low executive load task

low executive load task

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation between Trail Making Test Z-score and usability score (low executive load)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation between Trail Making Test Z-score and UEQ score (low executive load)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Angers

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 april 2028

Studie voltooiing (Geschat)

15 mei 2028

Studieregistratiedata

Eerst ingediend

8 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 september 2026

Eerst geplaatst (Werkelijk)

22 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2026-A01625-46

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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