Remote Cognitive Multidomain Assessment in People With Cognitive Disorders
NCT06078332, Completed, Azienda Ospedaliera Universitaria Integrata Verona
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Remote Cognitive Multidomain Assessment in People With Cognitive Disorders | ClinicalTrials.gov |
| NCT number | NCT06078332 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 114 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona | ClinicalTrials.gov |
| Conditions | Dementia, Cognitive Disorders, Neuropsychological Tests, Cognitive Assessment | ClinicalTrials.gov |
| First posted | 2023-10-11 | ClinicalTrials.gov |
| Last updated | 2024-03-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Comparison of the remote and face-to-face performance on the Mini-Mental State Examination (MMSE) | 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. | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Activities of Daily Living (ADL) scale | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Instrumental Activities of Daily Living (IADL) scale | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Rey Auditory Verbal Learning Test (RAVLT) | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Forward and Backward Digit Span (DS) test | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Clock Drawing Test (CDT) | 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. | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Frontal Assessment Battery (FAB) | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Stroop Color and Word Test (SCWT) | 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. | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Raven's Coloured Progressive Matrices (CPM) test | 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. | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Phonemic Verbal Fluency test | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Semantic Verbal Fluency test | 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). | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the Constructional Praxis test | 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. | ClinicalTrials.gov |
| Primary | Comparison of the remote and face-to-face performance on the oral version of Symbol Digit Modalities Test (SDMT) | 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). | ClinicalTrials.gov |
| Secondary | Feasibility and satisfaction degree of people with cognitive disorders and caregivers about the remote neuropsychological assessment | Day 15 (t1) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Clock Drawing Task | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Matrix Reasoning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)