Advances in Telephone-based Cognitive Screening Procedures

NCT ID: NCT06337578

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2026-10-25

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 (i.e., 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 and/or 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 . i.e. 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 (i.e., 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 (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 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-sectional/longitudinal 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-TICS/MMSE/MoCA.

Conditions

Amyotrophic Lateral Sclerosis; Alzheimer's Disease; Lewy Body Dementia; Frontotemporal Degeneration; Cerebrovascular Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with amyotrophic lateral sclerosis (ALS)

Individuals having been received a clinical diagnosis of amyotrophic lateral sclerosis according to current diagnostic criteria

Telephone-based neuropsychological assessment - ALS

Intervention Type: BEHAVIORAL

ALS patients will be administered the following TBCS tests:

• ALS Cognitive Behavioral Screen-Phone Version;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

This group will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Caregiver Behavioral Questionnaire;
• ECAS-Carer Interview.

Patients with Alzheimer's disease (AD)

Individuals having been received a neurochemical and/or aclinical diagnosis of Alzheimer's according to current diagnostic criteria

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

Intervention Type: BEHAVIORAL

AD, DLB, FTD and CVD patients will be administered the following TBCS tests:

• Telephone Interview for Cognitive Status;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Neuropsychiatric Inventory;
• Frontal Behavioural Inventory.

Patients with Lewy body dementia (LBD)

Individuals having been received a clinical diagnosis of Lewy body dementia according to current diagnostic criteria

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

Intervention Type: BEHAVIORAL

AD, DLB, FTD and CVD patients will be administered the following TBCS tests:

• Telephone Interview for Cognitive Status;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Neuropsychiatric Inventory;
• Frontal Behavioural Inventory.

Patients with frontotemporal dementia (FTD)

Individuals having been received a clinical diagnosis of frontotemporal dementia (i.e., behavioural variant-frontotemporal dementia; semantic dementia; progressive non-fluent aphasia) according to current diagnostic criteria

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

Intervention Type: BEHAVIORAL

AD, DLB, FTD and CVD patients will be administered the following TBCS tests:

• Telephone Interview for Cognitive Status;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Neuropsychiatric Inventory;
• Frontal Behavioural Inventory.

Patients with chronic cerebrovascular disorders (CVD)

Individuals with mild cognitive impairment/dementia and neuroradiological evidence of chronic cerebrovascular diseases

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

Intervention Type: BEHAVIORAL

AD, DLB, FTD and CVD patients will be administered the following TBCS tests:

• Telephone Interview for Cognitive Status;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Neuropsychiatric Inventory;
• Frontal Behavioural Inventory.

Normotypical individuals (NI)

Individuals without brain disorders

Telephone-based and in-person cognitive screening - NIs

Intervention Type: BEHAVIORAL

NIs will undergo the Telephone Interview for Cognitive Status over the telephone and will be additionally administered, in person, the following cognitive screeners:

• Mini-Mental State Examination
• Montreal Cognitive Assessment
• In-Person Telephone Interview for Cognitive Status in person.

Interventions

Telephone-based neuropsychological assessment - ALS

ALS patients will be administered the following TBCS tests:

• ALS Cognitive Behavioral Screen-Phone Version;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

This group will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Caregiver Behavioral Questionnaire;
• ECAS-Carer Interview.

Intervention Type: BEHAVIORAL

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

AD, DLB, FTD and CVD patients will be administered the following TBCS tests:

• Telephone Interview for Cognitive Status;
• Telephone-based Frontal Assessment Battery;
• Telephone Language Screener;
• Telephone-based Verbal Fluency Battery;

These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:

• Activities of Daily Living;
• Instrumental Activities of Daily Living;
• Amsterdam IADL Questionnaire - Short Version;
• Neuropsychiatric Inventory;
• Frontal Behavioural Inventory.

Intervention Type: BEHAVIORAL

Telephone-based and in-person cognitive screening - NIs

NIs will undergo the Telephone Interview for Cognitive Status over the telephone and will be additionally administered, in person, the following cognitive screeners:

• Mini-Mental State Examination
• Montreal Cognitive Assessment
• In-Person Telephone Interview for Cognitive Status in person.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Patient cohorts: diagnosis of interest. NIs: not applicable

Exclusion Criteria

Patient cohorts

• age <18 years;
• denial of informed consent to voluntary participation and data processing;
• absence of the diagnosis of interest;
• absence of a de visu cognitive screening assessment carried out in the 6 months prior to recruitment;
• positive history of 1) psychiatric pathologies, 2) serious and/or uncompensated general-medical conditions and 3) uncorrected visual/hearing deficits.

NIs:

• age <18 years;
• denial of informed consent to voluntary participation and data processing;
• positive history of 1) brain disorders, 2) serious and/or uncompensated general-medical conditions and 3) uncorrected visual/hearing deficits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara Poletti, Ph.D.

Role: CONTACT

Phone: +390261911

Email: b.poletti@auxologico.it

Facility Contacts

Barbara Poletti, Ph.D.

Role: primary

Other Identifiers

23C308

Identifier Type: -

Identifier Source: org_study_id