Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care

NCT06416137 | Not Yet Recruiting

• 1 other identifier: GR-2021-12372081
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The number of older migrants with cognitive impairment and dementia living in Italy and attending national healthcare services is rapidly increasing. There is a need to develop diversity-sensitive policies and practices to include migrants and people with different cultural values in the public health response to dementia.

Conditions

Dementia; Alzheimer Disease

Keywords

dementia; migrants; cross-cultural

Outcome Measures

Primary Outcomes (1)

• Global cognitive functioning

  Global cognitive functioning will be assessed through the Rowland Universal Dementia Assessment Scale (RUDAS). This is a short cognitive screening instrument designed to minimise the effects of cultural learning and language diversity on the assessment of baseline cognitive performance. The score ranges from 0 to 30. Higher scores indicate better cognitive functioning.

  Baseline

Secondary Outcomes (2)

• Frailty

  Baseline

• Risk factors

  Baseline

Study Arms (2)

Migrants

A group of 1,500 migrants with cognitive impairment will be enrolled at CCDDs.

Diagnostic Test: Neuropsychological tests

Natives

A group of 1,500 natives with cognitive impairment will be enrolled at CCDDs.

Diagnostic Test: Neuropsychological tests

Interventions

Neuropsychological tests DIAGNOSTIC_TEST

Participants will be assessed with neuropsychological tests and will be collected information about their lifestyle, clinical history and sociodemographic status. Special attention will be paid to the presence of modifiable risk factors for dementia (i.e., low education, hearing impairment, traumatic brain injury, excessive alcohol consumption, obesity, smoking, hypertension, depression, physical inactivity, diabetes, and social isolation).

Migrants; Natives

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All migrants consecutively referred to CCDDs due to cognitive disturbances in one year will be considered. The following definition of migrants will be consistently adopted in the project: any person living in Italy but born abroad, regardless of the legal status, the reason for migration, and the length of the stay (source: International Organization for Migration).

You may qualify if:

• Migrant (person who was not born in Italy) attending an Italian CCDD;
• Presence of a cognitive impairment.

You may not qualify if:

• A person without any cognitive impairment.

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead

Related Links

• The website created during the first part of this project.

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Marco Canevelli

CONTACT

+393393415890; marco.canevelli@iss.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: June 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 36 months by the beginning of the study