GerontologyEFFETNCT07834775
EFFET - Study of Executive Functions Regarding the Usability and User Experience of Assistive Technologies Among the Elderly
A study testing high executive load task and low executive load task in people with Gerontology and Cognitive Ability General, run by University Hospital, Angers at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gerontology, Cognitive Ability General, Technology Use
- What is being tested?
- high executive load task and low executive load task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Oct 2026to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Résidence Ovelia
Angers, Maine Et Loire, 49000
Emma COMBRET, +33 0241355030, emma.combret@etud.univ-angers.fr
Résidence Espace et Vie
Angers, Maine Et Loire, 49100
Emma COMBRET, +33 0241355030, emma.combret@etud.univ-angers.fr
Résidence Grégoire Bordillon
Angers, Maine Et Loire, 49100
Emma COMBRET, +33 0241355030, emma.combret@etud.univ-angers.fr
About this study
Official title: 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.
Read more
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
- Being tested
- high executive load task, low executive load task
- Keywords
- Gerontology,, cognitive load, technology, executive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high executive load taskOther
high executive load task
low executive load taskOther
low executive load task
| Study group | Role | What they receive |
|---|---|---|
| High-executive-load task first | Other | Participants realise high-executive-load task and then low-executive-load task Receives: 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 Receives: Other: high executive load task; Other: low executive load task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
MDPQ-16 score
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.
Measured: Visit 1 (48 hours to 15 days after informing the participants)
CRI-q score
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).
Measured: Visit 1 (48 hours to 15 days after informing the participants)
STAM score
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).
Measured: Visit 1 (48 hours to 15 days after informing the participants)
Usability score (low vs. high executive load)
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).
Measured: Visit 2 (24 hours to 1 month after visit 1)
User experience score (low vs. high executive load)
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).
Measured: Visit 2 (24 hours to 1 month after visit 1)
Perceived cognitive load score (low vs. high executive load)
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).
Measured: Visit 2 (24 hours to 1 month after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GerontologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834775
- Sponsor's protocol ID
- 2026-A01625-46
- Acronym
- EFFET
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07834775
- Acronym / sponsor ID
- EFFET / 2026-A01625-46
- Conditions
- Gerontology, Cognitive Ability General, Technology Use
- Keywords
- Gerontology,, cognitive load, technology, executive function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-executive-load task first | Other | Other: high executive load task, Other: low executive load taskParticipants realise high-executive-load task and then low-executive-load task |
| low-executive-load task first | Other | Other: high executive load task, Other: low executive load taskParticipants realise low-executive-load task and then high-executive-load task |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high executive load taskhigh executive load task | Other | High-executive-load task first, low-executive-load task first |
| low executive load tasklow executive load task | Other | High-executive-load task first, low-executive-load task first |
Primary outcome
Correlation between Trail Making Test Z-score and usability score (low executive load)
Time frame: 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.
11 secondary outcomes
Correlation between Trail Making Test Z-score and UEQ score (low executive load)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)
MDPQ-16 score
Time frame: Visit 1 (48 hours to 15 days after informing the participants)
CRI-q score
Time frame: Visit 1 (48 hours to 15 days after informing the participants)
STAM score
Time frame: Visit 1 (48 hours to 15 days after informing the participants)
Usability score (low vs. high executive load)
Time frame: Visit 2 (24 hours to 1 month after visit 1)
User experience score (low vs. high executive load)
Time frame: Visit 2 (24 hours to 1 month after visit 1)
Perceived cognitive load score (low vs. high executive load)
Time frame: Visit 2 (24 hours to 1 month after visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high executive load task and low executive load task in people with Gerontology and Cognitive Ability General, run by University Hospital, Angers at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma COMBRET, Psychologist (+33 0241355030, emma.combret@etud.univ-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Trail Making Test Z-score and usability score (low executive load) (time frame: Visit 1 (48 hours to 15 days after informing the participants), Visit 2 (24 hours to 1 month after visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.