Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

16 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: High-executive-load task first

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

high executive load task

low executive load task

Otro: low-executive-load task first

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

high executive load task

low executive load task

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between Trail Making Test Z-score and usability score (low executive load)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between Trail Making Test Z-score and UEQ score (low executive load)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de abril de 2028

Finalización del estudio (Estimado)

15 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Publicado por primera vez (Actual)

22 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2026-A01625-46

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir