Remote Cognitive Multidomain Assessment in People With Cognitive Disorders

Dementia Clinical Trial

Official title: Reliability of Remote Neuropsychological Assessment in People With Cognitive Disorders

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• Cognitive Dysfunction
• Dementia
• Neuropsychological Tests

• NCT number: NCT06078332
• Study type: Observational
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Status: Completed
• Start date: December 16, 2021
• Completion date: December 19, 2023