DementiaNCT06416137
Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care
An observational study of Dementia and Alzheimer Disease, run by Istituto Superiore di Sanità.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Neuropsychological tests
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- 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).
Who may be able to join
- Migrant (person who was not born in Italy) attending an Italian CCDD;
- Presence of a cognitive impairment.
Who cannot join
- A person without any cognitive impairment.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Based on the gaps and barriers identified by the ImmiDem study (GR-2016-02364975), the present project aims to:
- 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
- Dementia, Alzheimer Disease
- Being tested
- Neuropsychological tests
- Keywords
- dementia, migrants, cross-cultural
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Migrants | A group of 1,500 migrants with cognitive impairment will be enrolled at CCDDs. Receives: Diagnostic Test: Neuropsychological tests | |
| Natives | A group of 1,500 natives with cognitive impairment will be enrolled at CCDDs. Receives: Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Sanità
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Canevelli, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416137
- Sponsor's protocol ID
- GR-2021-12372081
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care
- ClinicalTrials.gov ID
- NCT06416137
- Acronym / sponsor ID
- GR-2021-12372081
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- dementia, migrants, cross-cultural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Istituto Superiore di SanitàUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migrants | – | Diagnostic Test: Neuropsychological testsA group of 1,500 migrants with cognitive impairment will be enrolled at CCDDs. |
| Natives | – | Diagnostic Test: Neuropsychological testsA group of 1,500 natives with cognitive impairment will be enrolled at CCDDs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (2 listed)
- Migrant (person who was not born in Italy) attending an Italian CCDD;
- Presence of a cognitive impairment.
Key exclusion criteria (1 listed)
- A person without any cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testsParticipants 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). | Diagnostic test | Migrants, Natives |
Primary outcome
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.
2 secondary outcomes
Frailty
Time frame: Baseline
Risk factors
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- The website created during the first part of this project.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Alzheimer Disease, run by Istituto Superiore di Sanità.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Canevelli (+393393415890, marco.canevelli@iss.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive functioning (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.