Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078332
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-10-05
Brief Title:
Remote Cognitive Multidomain Assessment in People With Cognitive Disorders
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Azienda Ospedaliera Universitaria Integrata Verona
Study Overview
Official Title:
Reliability of Remote Neuropsychological Assessment in People With Cognitive Disorders
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor caregivers will complete a satisfaction questionnaire about the remote administration
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 andor 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None