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

NCT07834775 | Not Yet Recruiting

• 1 other identifier: 2026-A01625-46
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gerontology; Cognitive Ability General; Technology Use

Keywords

Gerontology,; cognitive load; technology; executive function

Outcome Measures

Primary Outcomes (1)

• Correlation between Trail Making Test Z-score and usability score (low executive load)

  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)

Secondary Outcomes (11)

• Correlation between Trail Making Test Z-score and UEQ score (low executive load)

  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)

  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)

  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)

  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)

  Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)

Study Arms (2)

High-executive-load task first

OTHER

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

Other: high executive load task; Other: low executive load task

low-executive-load task first

OTHER

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

Other: high executive load task; Other: low executive load task

Interventions

high executive load task OTHER

high executive load task

High-executive-load task first; low-executive-load task first

low executive load task OTHER

low executive load task

High-executive-load task first; low-executive-load task first

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (3)

Résidence Ovelia

Angers, Maine Et Loire, 49000, France

Location

Résidence Espace et Vie

Angers, Maine Et Loire, 49100, France

Location

Résidence Grégoire Bordillon

Angers, Maine Et Loire, 49100, France

Location

Central Study Contacts

Emma COMBRET, Psychologist

CONTACT

+33 0241355030; emma.combret@etud.univ-angers.fr

Frédéric NOUBLANCHE

CONTACT

+33 0241355030; FrNoublanche@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The participants form a single group and complete all conditions of the numerical task. The order of administration of the two tasks (low executive load and high executive load) is randomized to control for learning or fatigue effects.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

FR (3)