## Protocol Section
### Identification Module
**NCT ID:** NCT06416137

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

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

#### Organization Study ID Info
**ID:** GR-2021-12372081
#### Organization
**Class:** OTHER
**Full Name:** Istituto Superiore di Sanità
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Superiore di Sanità

#### Responsible Party

**Investigator Affiliation:** Istituto Superiore di Sanità

**Investigator Full Name:** Marco Canevelli

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**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.

**Detailed Description:** Based on the gaps and barriers identified by the ImmiDem study (GR-2016-02364975), the present project aims to:

i) Describe the clinical and sociodemographic characteristics of migrants with cognitive disorders living in Italy, their health outcomes, and their access to healthcare resources; ii) develop and disseminate screening and assessment tools allowing the cross-cultural cognitive examination of individuals with a migration background; iii) raise awareness about dementia among culturally diverse people and train healthcare professionals in how to provide culturally competent care and support for migrants with cognitive disorders.

### Conditions Module

**Conditions:**

- Dementia

- Alzheimer Disease

**Keywords:**

- dementia

- migrants

- cross-cultural

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 3000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: Neuropsychological tests

**Label:** Migrants

#### Arm Group 2

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

**Intervention Names:**

- Diagnostic Test: Neuropsychological tests

**Label:** Natives

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Migrants

- Natives

**Description:** 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).

**Name:** Neuropsychological tests

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Global cognitive functioning

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Frailty will be assessed by computing a Frailty Index (FI) focusing on the clinical history of the patient and collecting diverse deficits. Patients with a higher number of deficits will be considered frailer.

**Measure:** Frailty

**Time Frame:** Baseline

**Description:** 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). They will be collected and analyzed through a specific questionnaire.

**Measure:** Risk factors

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* A person without any cognitive impairment.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marco.canevelli@iss.it

**Name:** Marco Canevelli

**Phone:** +393393415890

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** A workshop will be organized at the end of the project for disseminating the study results to major stakeholders (e.g., healthcare professionals, representatives of migrant communities, local authorities).

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** After 36 months by the beginning of the study

### References Module

#### See Also Links

**Label:** The website created during the first part of this project.

**URL:** http://www.immidem.it/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: HIGH

- As Found: Dementia

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

- ID: D000003704

- Term: Dementia

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
