Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337578
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Brief Title:
Advances in Telephone-based Cognitive Screening Procedures
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Avanzamenti in Materia di Screening Cognitivo Telefonico
Status:
RECRUITING
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:
TBCS
Brief Summary:
1 Background
Cognitive screening procedures via performance-based tests represent an essential albeit preliminary element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders Furthermore in these populations cognitive screening measures are often employed as outcomes in epidemiological settings as well as endpoints in clinical trials Therefore cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific ie specific to each language and culture
The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening TBCS procedures - which until recently have been mostly neglected in Italy despite having the potential to bring clear benefits to clinical practice and research In fact TBCS techniques allow through the use of a very widespread accessible and easy-to-use telecommunication medium to break down the geographical logistical socio-demographic and organizational barriers that make it difficult andor prevent 1 access to these clinical services and 2 the continuity of their provision as well as the creation and completion of 3 large-scale epidemiological studies and 4 decentralized clinical trials However although some TBCS tests have recently been developed and standardized in Italy their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated Furthermore currently the paper-and-pencil version of the international gold-standard for TBCS procedures ie the Telephone Interview For Cognitive Status TICS which has been recently standardized in this country - is not available within the Italian scenario In fact although the feasibility of a de visu version of the TICS ie In-Person TICS IP-TICS has been demonstrated in this country an actual standardization of this test has not yet been implemented to date Such a tool would however allow flexible use of screening assessments regardless of the delivery method both in clinical and experimental contexts
2 Aims
The present study primarily aims to provide exhaustive evidence regarding the psychometric diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders Secondly this study aims to derive in normotypical Italian subjects 1 normative data for the IP-TICS and 2 the conversion algorithms between the latter and other widely used paper-and-pencil screeners and the TICS
3 Methods
The study is monocentric observational prospective Over a period of 3 years patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited 1 amyotrophic lateral sclerosis N88 2 Alzheimers disease N66 3 Lewy body dementia N30 4 frontotemporal dementia N30 5 chronic cerebrovascular disorders N66 Furthermore N287 normotypical subjects representative of the Italian population will be recruited The following TBCS tests will be administered to patients 1 TICS 2 Telephone-based Frontal Assessment Battery 3 Telephone Language Screener 4 Telephone-based Verbal Fluency Battery 5 ALS Cognitive Behavioral Screen-Phone Version Additionally patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes Normal subjects will instead be administered 1 TICS 2 IP-TICS 3 Mini-Mental State Examination MMSE 4 Montreal Cognitive Assessment MoCA In patients telephone follow-ups are expected after 6 12 and 18 months Statistical analyses will be carried out aimed at 1 the detailed study in patients of the psychometrics diagnostics and cross-sectionallongitudinal clinical usability of the aforementioned TBCS test as well as at 2 the derivation in normotypical subjects of the normative data of the IP-TICS and MoCA Memory Index Score MIS as well as the conversion algorithms between TICS and IP-TICSMMSEMoCA
Cognitive screening procedures via performance-based tests represent an essential albeit preliminary element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders Furthermore in these populations cognitive screening measures are often employed as outcomes in epidemiological settings as well as endpoints in clinical trials Therefore cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific ie specific to each language and culture
The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening TBCS procedures - which until recently have been mostly neglected in Italy despite having the potential to bring clear benefits to clinical practice and research In fact TBCS techniques allow through the use of a very widespread accessible and easy-to-use telecommunication medium to break down the geographical logistical socio-demographic and organizational barriers that make it difficult andor prevent 1 access to these clinical services and 2 the continuity of their provision as well as the creation and completion of 3 large-scale epidemiological studies and 4 decentralized clinical trials However although some TBCS tests have recently been developed and standardized in Italy their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated Furthermore currently the paper-and-pencil version of the international gold-standard for TBCS procedures ie the Telephone Interview For Cognitive Status TICS which has been recently standardized in this country - is not available within the Italian scenario In fact although the feasibility of a de visu version of the TICS ie In-Person TICS IP-TICS has been demonstrated in this country an actual standardization of this test has not yet been implemented to date Such a tool would however allow flexible use of screening assessments regardless of the delivery method both in clinical and experimental contexts
2 Aims
The present study primarily aims to provide exhaustive evidence regarding the psychometric diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders Secondly this study aims to derive in normotypical Italian subjects 1 normative data for the IP-TICS and 2 the conversion algorithms between the latter and other widely used paper-and-pencil screeners and the TICS
3 Methods
The study is monocentric observational prospective Over a period of 3 years patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited 1 amyotrophic lateral sclerosis N88 2 Alzheimers disease N66 3 Lewy body dementia N30 4 frontotemporal dementia N30 5 chronic cerebrovascular disorders N66 Furthermore N287 normotypical subjects representative of the Italian population will be recruited The following TBCS tests will be administered to patients 1 TICS 2 Telephone-based Frontal Assessment Battery 3 Telephone Language Screener 4 Telephone-based Verbal Fluency Battery 5 ALS Cognitive Behavioral Screen-Phone Version Additionally patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes Normal subjects will instead be administered 1 TICS 2 IP-TICS 3 Mini-Mental State Examination MMSE 4 Montreal Cognitive Assessment MoCA In patients telephone follow-ups are expected after 6 12 and 18 months Statistical analyses will be carried out aimed at 1 the detailed study in patients of the psychometrics diagnostics and cross-sectionallongitudinal clinical usability of the aforementioned TBCS test as well as at 2 the derivation in normotypical subjects of the normative data of the IP-TICS and MoCA Memory Index Score MIS as well as the conversion algorithms between TICS and IP-TICSMMSEMoCA
Detailed Description:
None
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