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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416137
• Other study ID #: GR-2021-12372081
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Istituto Superiore di Sanità
• Contact: Marco Canevelli
• Phone: +393393415890
• Email: marco.canevelli[@]iss.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Diagnostic Test:
• Neuropsychological tests
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Superiore di Sanità

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frailty	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.	Baseline
Secondary	Risk factors	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.	Baseline

External Links

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