Clinical trial NCT06078332: Remote Cognitive Multidomain Assessment in People With Cognitive Disorders
Official title: Reliability of Remote Neuropsychological Assessment in People With Cognitive Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Cognitive Disorders
Neuropsychological Tests
Cognitive Assessment
Keywords: Remote neuropsychological assessment
Telemedicine
Cognitive impairment
Dementia
Domain-specific neuropsychological tests
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Comparison of the remote and face-to-face performance on the Mini-Mental State Examination (MMSE)
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Activities of Daily Living (ADL) scale
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Instrumental Activities of Daily Living (IADL) scale
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Forward and Backward Digit Span (DS) test
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Clock Drawing Test (CDT)
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Frontal Assessment Battery (FAB)
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Stroop Color and Word Test (SCWT)
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Raven's Coloured Progressive Matrices (CPM) test
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Phonemic Verbal Fluency test
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Semantic Verbal Fluency test
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the Constructional Praxis test
timeFrame: Day 1 (t0) and Day 15 (t1)
measure: Comparison of the remote and face-to-face performance on the oral version of Symbol Digit Modalities Test (SDMT)
timeFrame: Day 1 (t0) and Day 15 (t1)
Secondary outcomes:
measure: Feasibility and satisfaction degree of people with cognitive disorders and caregivers about the remote neuropsychological assessment
timeFrame: Day 15 (t1)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University Hospital of Verona
state: VR
Study officials:
affiliation: University Hospital of Verona
name: Chiara Zucchella, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wadsworth 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.
citation: Beishon 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.
citation: Carotenuto 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.