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

May 10, 2024 updated by: Marco Canevelli, Istituto Superiore di Sanità
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Migrants
A group of 1,500 migrants with cognitive impairment will be enrolled at CCDDs.
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).
Natives
A group of 1,500 natives with cognitive impairment will be enrolled at CCDDs.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognitive functioning
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Baseline
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
Risk factors
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2021-12372081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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).

IPD Sharing Time Frame

After 36 months by the beginning of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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