DementiaNCT06078332
Remote Cognitive Multidomain Assessment in People With Cognitive Disorders
An observational study of Dementia and Cognitive Disorders, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Digital medicine is a useful clinical resource for people with cognitive disorders. Scientific literature has shown that in people with dementia neuropsychological instruments administered in remote are characterized by high psychometric quality and satisfaction levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Cognitive Disorders, Neuropsychological Tests
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2021to 19 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll consecutive patients referring to the Center for cognitive disorders and dementia of the Verona Hospital (AOUI Verona, Neurology A), already diagnosed with Major Neurocognitive Disorder, Mild Neurocognitive Disorder, or Subjective Cognitive Disorder according to the DSM 5 diagnostic criteria (APA, 2013), regardless of the etiological diagnosis of disease.
Who may be able to join
- Being in care at the CDCD of the Verona hospital;
- Diagnosis of Major Neurocognitive Disorder, Mild Neurocognitive Disorder, or Subjective Cognitive Disorder according to DSM 5 criteria;
- Availability of a caregiver for technical support;
- Availability of a device equipped with camera and microphone and internet connection to do the video call;
- Informed consent signed by the patient, the legal representative if present, and the caregiver.
Who cannot join
- Severe sensory deficits;
- Non-native Italian speakers;
- Primary Psychiatric Disorder;
- MMSE score less than 10;
- Severe Behaviour and Psychological Symptoms of Dementia that limit collaboration;
- Aphasia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Remote Neuropsychological Assessment in People With Cognitive Disorders
Digital medicine is a useful clinical resource for people with cognitive disorders. Scientific literature has shown that in people with dementia neuropsychological instruments administered in remote are characterized by high psychometric quality and satisfaction levels. However, evidence about the reliability of remote neuropsychological domain-specific tests is still limited in the Italian context.
The principal aims of the study will be 1) to evaluate the reliability of the remote administration of neuropsychological screening and domain-specific tests compared to the face-to-face administration in patients with cognitive disorders; 2) to assess the feasibility and level of satisfaction of patients and caregivers about remote administration.
All participants will be submitted to both face-to-face and remote neuropsychological assessment (by videoconference) in a counterbalanced cross-over design. Finally, all patients and/or caregivers will complete a satisfaction questionnaire about the remote administration.
Read the detailed description
The pilot study will enroll consecutive patients referring to the Center for cognitive disorders and dementia, UOC Neurology A of the AOUI Verona. For all participants will be obtained a written informed consent after a detailed information during the visit of normal clinical practice.
All patients included will be submitted (in presence or remotely) to a screening assessment of global cognition and level of autonomy in daily life. People with subjective or milder cognitive disorders will be also submitted to a standardized battery of neuropsychological tests aimed at the investigation of specific cognitive areas (memory, attention, executive functions, etc.) (T0). After 15 days (T1) each participant will repeat the same assessment in the mode of administration opposite to the previous one. So, all participants will be submitted to both face-to-face and remote neuropsychological assessment in a counterbalanced cross-over design to reduce the learning bias; half of the participants will perform the first assessment in presence, the other half the first assessment in remote mode. The two neuropsychological assessments will be administered by two psychologists independently.
Finally, all patients and/or caregivers completed a satisfaction questionnaire about the remote administration.
Presence assessment will be carried out in the hospital clinic, according to the normal procedures of good clinical practice. Remote assessment will be carried out through the Virtual Care - Pohema telemedicine platform (developed by GPI SpA), using its function of televisit. The selected neuropsychological instruments are paper-and-pencil and oral tests; the material will be presented to participants via screen sharing.
To assess the reliability of the neuropsychological tests administered in remote mode, the quantitative scores corrected by age, education, and sex (normative tables) will be considered and the statistical analysis Paired Sample T-Test will be used. Graphic comparisons will also be made using the method described by Bland and Altman and Intraclass Correlation Coefficients (ICC) will be calculated.
To assess the feasibility and satisfaction level of patients and caregivers related to remote administration, will be calculate the absolute and relative frequencies of the 2 modes of response (disagreement, agreement) to the 14 questions of the questionnaire developed ad hoc.
- Keywords
- Remote neuropsychological assessment, Telemedicine, Cognitive impairment, Dementia, Domain-specific neuropsychological tests
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Remote assessment first | Participants will perform the first neuropsychological assessment remotely via video conferencing. After 15 days, the participants will repeat the same neuropsychological tests (second assessment) face to face. Finally, participants and caregivers will complete online the satisfaction questionnaire about remote administration. | |
| Face-to-face assessment first | Participants will perform the first neuropsychological assessment in presence in the hospital. After 15 days, the participants will repeat the same neuropsychological tests (second assessment) remotely via video conferencing. Finally, participants and caregivers will complete online the satisfaction questionnaire about remote administration . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the remote and face-to-face performance on the Mini-Mental State Examination (MMSE)
The MMSE is a screening test of global cognition that includes tasks designated to asses space-temporal orientation, concentration, attention, verbal memory, naming and visuospatial skills. MMSE is scored from 0 to 30. The cut-off is 24 points. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment (Folstein et al., 1975; Magni et al., 1996).
In the remote assessment the visual stimuli (tasks of reading and copy of drawing) will be displayed on the video using the share screen option.
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Activities of Daily Living (ADL) scale
The ADL scale is an informant-based instrument that assesses the level of independence in six basic self-care functions: bathing, dressing, going to toilet, transferring, feeding, and continence. The total score ranges from 0 to 6; one point is given for each skill retained (0=complete dependence, 6=complete independence). The questionnaire can be completed by the patient or the caregiver (Katz et al., 1963).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Instrumental Activities of Daily Living (IADL) scale
The IADL scale was developed to assess the person's level of independence in more complex activities (termed "instrumental activities") necessary for functioning in community settings. The graded scale measures 8 domains of function: telephone use, shopping, cooking, food preparation, housekeeping, laundering, taking drugs, and managing finances. Historically, women were scored on all 8 areas of function; men were scored in only 5 domains. One point is given for each skill retained. The total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The questionnaire can be completed by the patient or the caregiver (Lawton e Brody, 1969).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT evaluates verbal learning and memory. The test is designed as a list-learning paradigm and includes three tasks: 1) "immediate recall" (score range from 0-75); 2) "delayed recall" (score range from 0-15); 3) "recognition". The score is given by the number of words correctly remembered; higher the score, better the performance. Omissions and false positives are also counted in the recognition task (Carlesimo et al., 1996).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Forward and Backward Digit Span (DS) test
The Forward and Backward DS tasks are used to assess verbal short-term memory and working memory respectively. The DS tests requires that participants listen to a series of digits and repeat the series in correct forward or backward order. The score is the length of the longest correctly repeated sequence. Higher the score, better the performance (Monaco et al., 2015).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Clock Drawing Test (CDT)
The CDT is used to quickly assess visuospatial, praxis, mental representation, planning and logical abilities. The person is asked to put the numbers on the watch, and then draw the hands to indicate a given moment. The maximum possible score is 10 points. The cut-off point is determined by the age and years of schooling of the person; higher scores indicate better performance (Mondini et al., 2003).
In the remote assessment the participant will draw the clock on a blank sheet and then show it to the camera.
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Frontal Assessment Battery (FAB)
The FAB is a short tool for the assessment of executive functions consisting of six subtests that explore different abilities related to the frontal lobes (Similarities, Lexical Fluency, Motor Series, Conflicting Instructions, Go-No-Go, Prehension Behaviour). The sum of the sub-scores from each of the six components are added up to generate total score out of 18. Higher scores indicate better performance; the cut-off point is 12 (Aiello et al., 2021).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Stroop Color and Word Test (SCWT)
The SCWT assesses selective attention and the ability to inhibit cognitive interference. People examined are required to read three different tables as quickly as possible. Two of them represent the congruous conditions (word reading, color naming), the third table represent the interference condition (named color-word). The two total scores "interference time" and "interference errors" are calculated from the completion times and number of errors for each condition by a formula. Higher scores indicate worst performance (Caffarra et al., 2002).
In the remote assessment the stimuli will be displayed on the video using the share screen option.
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Raven's Coloured Progressive Matrices (CPM) test
The Raven's CPM is a culture-fair test of nonverbal intelligence. The test includes 36 items that are divided into three sets of 12 (set A, Ab and B), in order of increasing difficulty within each set. The person is shown a large square that contains a pattern with a piece missing and is asked to complete the pattern by choosing the correct option from six available pieces. The score corresponds to the total number of matrices that have been successfully completed. Higher scores indicate better performance (Basso et al., 1987).
In the remote assessment the visual stimuli will be displayed on the video using the share screen option.
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Phonemic Verbal Fluency test
The Phonemic Verbal Fluency test assess the phonological lexical access performance. In the task examinees are asked to orally produce as many words beginning with a given letter (F, A and S) as possible in sixty seconds. The total score is obtained from the sum of the number of valid words produced for each letter. Higher scores indicate better performance (Carlesimo et al., 1996).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Semantic Verbal Fluency test
The Semantic Verbal Fluency test assess the semantic lexical access performance. In the task examinees are asked to orally produce as many words from a specific category (animals, fruit, vehicles) as possible in sixty seconds. The total score is obtained from the sum of the number of valid words produced for each category. Higher scores indicate better performance (Novelli et al., 1986).
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the Constructional Praxis test
The Constructional Praxis test assess visuoconstructive abilities. In particular, the ability to copy geometric forms, as well as visual planning skills. The test is composed of seven images of different geometric figures that are progressively more complex in terms of their shape. The examinees is asked to copy each figure once at a time, in the most accurate way possible. A drawing is considered correct (and receives 2 points) when the overall shape is reproduced. Each incorrect drawing receives the score of 1 or 0 points. The CPT total score may range from 0 to 14 points (Spinnler e Tognoni, 1987).
In the remote assessment the visual stimuli will be displayed on the video using the share screen option. The participant will draw the geometric figures on a blank sheet and then show them to the camera.
Measured: Day 1 (t0) and Day 15 (t1)
Comparison of the remote and face-to-face performance on the oral version of Symbol Digit Modalities Test (SDMT)
The SDMT is used to assess psychomotor speed, which measures processing speed as well as motor speed. Performance is also affected by attention, visual scanning and tracking, and working memory. Individuals are required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. Higher scores indicate better performance (Nocentini et al., 2006).
Measured: Day 1 (t0) and Day 15 (t1)
Secondary outcomes (1)
Feasibility and satisfaction degree of people with cognitive disorders and caregivers about the remote neuropsychological assessment
The feasibility and satisfaction degree about the remote neuropsychological assessment will be measured by a questionnaire that participants will complete immediately after the second and last evaluation. The questionnaire was developed ad hoc and it consists of 16 six-point Likert Scale questions (from Completely Agree to Completely Disagree) and an open-ended question (feedback or suggestions). A total score will not be calculated. Each item of the survey will be considered individually.
Measured: Day 15 (t1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start16 Dec 2021
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Zucchella, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Chiara Zucchella, PsyD, Principal investigator, University Hospital of Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078332
- Sponsor's protocol ID
- NPSTV
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Appleman ER, O'Connor MK, Boucher SJ, Rostami R, Sullivan SK, Migliorini R, Kraft M. Teleneuropsychology clinic development and patient satisfaction. Clin Neuropsychol. 2021 May;35(4):819-837. doi: 10.1080/13854046.2020.1871515. Epub 2021 Jan 27.
PubMed 33504268Wadsworth HE, Dhima K, Womack KB, Hart J Jr, Weiner MF, Hynan LS, Cullum CM. Validity of Teleneuropsychological Assessment in Older Patients with Cognitive Disorders. Arch Clin Neuropsychol. 2018 Dec 1;33(8):1040-1045. doi: 10.1093/arclin/acx140.
PubMed 29329363Beishon LC, Elliott E, Hietamies TM, Mc Ardle R, O'Mahony A, Elliott AR, Quinn TJ. Diagnostic test accuracy of remote, multidomain cognitive assessment (telephone and video call) for dementia. Cochrane Database Syst Rev. 2022 Apr 8;4(4):CD013724. doi: 10.1002/14651858.CD013724.pub2.
PubMed 35395108Carotenuto A, Rea R, Traini E, Ricci G, Fasanaro AM, Amenta F. Cognitive Assessment of Patients With Alzheimer's Disease by Telemedicine: Pilot Study. JMIR Ment Health. 2018 May 11;5(2):e31. doi: 10.2196/mental.8097.
PubMed 29752254Bressan MM, Musso AM, Bovi T, Bonetti B, Zucchella C. Tele-neuropsychological multidomain assessment in Italian people with cognitive disorders: Reliability and user satisfaction. J Alzheimers Dis. 2025 Jan;103(1):268-281. doi: 10.1177/13872877241300186. Epub 2024 Dec 19.
PubMed 39702991
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Remote Neuropsychological Assessment in People With Cognitive Disorders
- ClinicalTrials.gov ID
- NCT06078332
- Acronym / sponsor ID
- NPSTV
- Keywords
- Remote neuropsychological assessment, Telemedicine, Cognitive impairment, Dementia, Domain-specific neuropsychological tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 11 Oct 2023 (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.
Digital medicine is a useful clinical resource for people with cognitive disorders. Scientific literature has shown that in people with dementia neuropsychological instruments administered in remote are characterized by high psychometric quality and satisfaction levels. However, evidence about the reliability of remote neuropsychological domain-specific tests is still limited in the Italian context.
The principal aims of the study will be 1) to evaluate the reliability of the remote administration of neuropsychological screening and domain-specific tests compared to the face-to-face administration in patients with cognitive disorders; 2) to assess the feasibility and level of satisfaction of patients and caregivers about remote administration.
All participants will be submitted to both face-to-face and remote neuropsychological assessment (by videoconference) in a counterbalanced cross-over design. Finally, all patients and/or caregivers will complete a satisfaction questionnaire about the remote administration.
Detailed description
The pilot study will enroll consecutive patients referring to the Center for cognitive disorders and dementia, UOC Neurology A of the AOUI Verona. For all participants will be obtained a written informed consent after a detailed information during the visit of normal clinical practice.
All patients included will be submitted (in presence or remotely) to a screening assessment of global cognition and level of autonomy in daily life. People with subjective or milder cognitive disorders will be also submitted to a standardized battery of neuropsychological tests aimed at the investigation of specific cognitive areas (memory, attention, executive functions, etc.) (T0). After 15 days (T1) each participant will repeat the same assessment in the mode of administration opposite to the previous one. So, all participants will be submitted to both face-to-face and remote neuropsychological assessment in a counterbalanced cross-over design to reduce the learning bias; half of the participants will perform the first assessment in presence, the other half the first assessment in remote mode. The two neuropsychological assessments will be administered by two psychologists independently.
Finally, all patients and/or caregivers completed a satisfaction questionnaire about the remote administration.
Presence assessment will be carried out in the hospital clinic, according to the normal procedures of good clinical practice. Remote assessment will be carried out through the Virtual Care - Pohema telemedicine platform (developed by GPI SpA), using its function of televisit. The selected neuropsychological instruments are paper-and-pencil and oral tests; the material will be presented to participants via screen sharing.
To assess the reliability of the neuropsychological tests administered in remote mode, the quantitative scores corrected by age, education, and sex (normative tables) will be considered and the statistical analysis Paired Sample T-Test will be used. Graphic comparisons will also be made using the method described by Bland and Altman and Intraclass Correlation Coefficients (ICC) will be calculated.
To assess the feasibility and satisfaction level of patients and caregivers related to remote administration, will be calculate the absolute and relative frequencies of the 2 modes of response (disagreement, agreement) to the 14 questions of the questionnaire developed ad hoc.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote assessment first | – | –Participants will perform the first neuropsychological assessment remotely via video conferencing. After 15 days, the participants will repeat the same neuropsychological tests (second assessment) face to face. Finally, participants and caregivers will complete online the satisfaction questionnaire about remote administration. |
| Face-to-face assessment first | – | –Participants will perform the first neuropsychological assessment in presence in the hospital. After 15 days, the participants will repeat the same neuropsychological tests (second assessment) remotely via video conferencing. Finally, participants and caregivers will complete online the satisfaction questionnaire about remote administration . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll consecutive patients referring to the Center for cognitive disorders and dementia of the Verona Hospital (AOUI Verona, Neurology A), already diagnosed with Major Neurocognitive Disorder, Mild Neurocognitive Disorder, or Subjective Cognitive Disorder according to the DSM 5 diagnostic criteria (APA, 2013), regardless of the etiological diagnosis of disease.
Key inclusion criteria (5 listed)
- Being in care at the CDCD of the Verona hospital;
- Diagnosis of Major Neurocognitive Disorder, Mild Neurocognitive Disorder, or Subjective Cognitive Disorder according to DSM 5 criteria;
- Availability of a caregiver for technical support;
- Availability of a device equipped with camera and microphone and internet connection to do the video call;
- Informed consent signed by the patient, the legal representative if present, and the caregiver.
Key exclusion criteria (6 listed)
- Severe sensory deficits;
- Non-native Italian speakers;
- Primary Psychiatric Disorder;
- MMSE score less than 10;
- Severe Behaviour and Psychological Symptoms of Dementia that limit collaboration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the remote and face-to-face performance on the Mini-Mental State Examination (MMSE)
Time frame: Day 1 (t0) and Day 15 (t1)
The MMSE is a screening test of global cognition that includes tasks designated to asses space-temporal orientation, concentration, attention, verbal memory, naming and visuospatial skills. MMSE is scored from 0 to 30. The cut-off is 24 points. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment (Folstein et al., 1975; Magni et al., 1996). In the remote assessment the visual stimuli (tasks of reading and copy of drawing) will be displayed on the video using the share screen option.
Comparison of the remote and face-to-face performance on the Activities of Daily Living (ADL) scale
Time frame: Day 1 (t0) and Day 15 (t1)
The ADL scale is an informant-based instrument that assesses the level of independence in six basic self-care functions: bathing, dressing, going to toilet, transferring, feeding, and continence. The total score ranges from 0 to 6; one point is given for each skill retained (0=complete dependence, 6=complete independence). The questionnaire can be completed by the patient or the caregiver (Katz et al., 1963).
Comparison of the remote and face-to-face performance on the Instrumental Activities of Daily Living (IADL) scale
Time frame: Day 1 (t0) and Day 15 (t1)
The IADL scale was developed to assess the person's level of independence in more complex activities (termed "instrumental activities") necessary for functioning in community settings. The graded scale measures 8 domains of function: telephone use, shopping, cooking, food preparation, housekeeping, laundering, taking drugs, and managing finances. Historically, women were scored on all 8 areas of function; men were scored in only 5 domains. One point is given for each skill retained. The total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. The questionnaire can be completed by the patient or the caregiver (Lawton e Brody, 1969).
Comparison of the remote and face-to-face performance on the Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Day 1 (t0) and Day 15 (t1)
The RAVLT evaluates verbal learning and memory. The test is designed as a list-learning paradigm and includes three tasks: 1) "immediate recall" (score range from 0-75); 2) "delayed recall" (score range from 0-15); 3) "recognition". The score is given by the number of words correctly remembered; higher the score, better the performance. Omissions and false positives are also counted in the recognition task (Carlesimo et al., 1996).
Comparison of the remote and face-to-face performance on the Forward and Backward Digit Span (DS) test
Time frame: Day 1 (t0) and Day 15 (t1)
The Forward and Backward DS tasks are used to assess verbal short-term memory and working memory respectively. The DS tests requires that participants listen to a series of digits and repeat the series in correct forward or backward order. The score is the length of the longest correctly repeated sequence. Higher the score, better the performance (Monaco et al., 2015).
Comparison of the remote and face-to-face performance on the Clock Drawing Test (CDT)
Time frame: Day 1 (t0) and Day 15 (t1)
The CDT is used to quickly assess visuospatial, praxis, mental representation, planning and logical abilities. The person is asked to put the numbers on the watch, and then draw the hands to indicate a given moment. The maximum possible score is 10 points. The cut-off point is determined by the age and years of schooling of the person; higher scores indicate better performance (Mondini et al., 2003). In the remote assessment the participant will draw the clock on a blank sheet and then show it to the camera.
Comparison of the remote and face-to-face performance on the Frontal Assessment Battery (FAB)
Time frame: Day 1 (t0) and Day 15 (t1)
The FAB is a short tool for the assessment of executive functions consisting of six subtests that explore different abilities related to the frontal lobes (Similarities, Lexical Fluency, Motor Series, Conflicting Instructions, Go-No-Go, Prehension Behaviour). The sum of the sub-scores from each of the six components are added up to generate total score out of 18. Higher scores indicate better performance; the cut-off point is 12 (Aiello et al., 2021).
Comparison of the remote and face-to-face performance on the Stroop Color and Word Test (SCWT)
Time frame: Day 1 (t0) and Day 15 (t1)
The SCWT assesses selective attention and the ability to inhibit cognitive interference. People examined are required to read three different tables as quickly as possible. Two of them represent the congruous conditions (word reading, color naming), the third table represent the interference condition (named color-word). The two total scores "interference time" and "interference errors" are calculated from the completion times and number of errors for each condition by a formula. Higher scores indicate worst performance (Caffarra et al., 2002). In the remote assessment the stimuli will be displayed on the video using the share screen option.
Comparison of the remote and face-to-face performance on the Raven's Coloured Progressive Matrices (CPM) test
Time frame: Day 1 (t0) and Day 15 (t1)
The Raven's CPM is a culture-fair test of nonverbal intelligence. The test includes 36 items that are divided into three sets of 12 (set A, Ab and B), in order of increasing difficulty within each set. The person is shown a large square that contains a pattern with a piece missing and is asked to complete the pattern by choosing the correct option from six available pieces. The score corresponds to the total number of matrices that have been successfully completed. Higher scores indicate better performance (Basso et al., 1987). In the remote assessment the visual stimuli will be displayed on the video using the share screen option.
Comparison of the remote and face-to-face performance on the Phonemic Verbal Fluency test
Time frame: Day 1 (t0) and Day 15 (t1)
The Phonemic Verbal Fluency test assess the phonological lexical access performance. In the task examinees are asked to orally produce as many words beginning with a given letter (F, A and S) as possible in sixty seconds. The total score is obtained from the sum of the number of valid words produced for each letter. Higher scores indicate better performance (Carlesimo et al., 1996).
Comparison of the remote and face-to-face performance on the Semantic Verbal Fluency test
Time frame: Day 1 (t0) and Day 15 (t1)
The Semantic Verbal Fluency test assess the semantic lexical access performance. In the task examinees are asked to orally produce as many words from a specific category (animals, fruit, vehicles) as possible in sixty seconds. The total score is obtained from the sum of the number of valid words produced for each category. Higher scores indicate better performance (Novelli et al., 1986).
Comparison of the remote and face-to-face performance on the Constructional Praxis test
Time frame: Day 1 (t0) and Day 15 (t1)
The Constructional Praxis test assess visuoconstructive abilities. In particular, the ability to copy geometric forms, as well as visual planning skills. The test is composed of seven images of different geometric figures that are progressively more complex in terms of their shape. The examinees is asked to copy each figure once at a time, in the most accurate way possible. A drawing is considered correct (and receives 2 points) when the overall shape is reproduced. Each incorrect drawing receives the score of 1 or 0 points. The CPT total score may range from 0 to 14 points (Spinnler e Tognoni, 1987). In the remote assessment the visual stimuli will be displayed on the video using the share screen option. The participant will draw the geometric figures on a blank sheet and then show them to the camera.
Comparison of the remote and face-to-face performance on the oral version of Symbol Digit Modalities Test (SDMT)
Time frame: Day 1 (t0) and Day 15 (t1)
The SDMT is used to assess psychomotor speed, which measures processing speed as well as motor speed. Performance is also affected by attention, visual scanning and tracking, and working memory. Individuals are required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. Higher scores indicate better performance (Nocentini et al., 2006).
1 secondary outcome
Feasibility and satisfaction degree of people with cognitive disorders and caregivers about the remote neuropsychological assessment
Time frame: Day 15 (t1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 33504268Appleman ER, O'Connor MK, Boucher SJ, Rostami R, Sullivan SK, Migliorini R, Kraft M. Teleneuropsychology clinic development and patient satisfaction. Clin Neuropsychol. 2021 May;35(4):819-837. doi: 10.1080/13854046.2020.1871515. Epub 2021 Jan 27.
- Background: PubMed 29329363Wadsworth HE, Dhima K, Womack KB, Hart J Jr, Weiner MF, Hynan LS, Cullum CM. Validity of Teleneuropsychological Assessment in Older Patients with Cognitive Disorders. Arch Clin Neuropsychol. 2018 Dec 1;33(8):1040-1045. doi: 10.1093/arclin/acx140.
- Background: PubMed 35395108Beishon LC, Elliott E, Hietamies TM, Mc Ardle R, O'Mahony A, Elliott AR, Quinn TJ. Diagnostic test accuracy of remote, multidomain cognitive assessment (telephone and video call) for dementia. Cochrane Database Syst Rev. 2022 Apr 8;4(4):CD013724. doi: 10.1002/14651858.CD013724.pub2.
- Background: PubMed 29752254Carotenuto A, Rea R, Traini E, Ricci G, Fasanaro AM, Amenta F. Cognitive Assessment of Patients With Alzheimer's Disease by Telemedicine: Pilot Study. JMIR Ment Health. 2018 May 11;5(2):e31. doi: 10.2196/mental.8097.
- Derived from this study: PubMed 39702991Bressan MM, Musso AM, Bovi T, Bonetti B, Zucchella C. Tele-neuropsychological multidomain assessment in Italian people with cognitive disorders: Reliability and user satisfaction. J Alzheimers Dis. 2025 Jan;103(1):268-281. doi: 10.1177/13872877241300186. Epub 2024 Dec 19.
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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. This study is not recruiting at the moment.
Chiara Zucchella, PsyD principal investigator
University Hospital of Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Cognitive Disorders, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the remote and face-to-face performance on the Mini-Mental State Examination (MMSE) (time frame: Day 1 (t0) and Day 15 (t1)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078332, which also lists 5 linked publications.
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 12 Mar 2024.