DementiaNCT05163821
Pilot of a New Cognitive Assessment Tool for Detecting Dementia in the Migrant Somali Population
An observational study of Dementia, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Aims The investigators want to find out if the tool that they have made to assess memory and thinking in Somali elders ( the 'MSCAT') is acceptable to that community and practical to administer and score. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Manchester Somali Cognitive Assessment Tool and ACE-III Somali Translation
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2022to 4 Dec 2023
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Somali-born migrants in UK
Who may be able to join
- The participants will all be Somali-born migrants, over the age of 50, living in the UK.
Who cannot join
- Exclusion criteria will include the presence of dementia, current delirium, or inability to complete the tasks due to visual/hearing/physical impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Greater Manchester Mental Health NHS Trust
Manchester, M13 9WL
About this study
Aims
- The investigators want to find out if the tool that they have made to assess memory and thinking in Somali elders ( the 'MSCAT') is acceptable to that community and practical to administer and score.
- The public will benefit from this research because it seeks to enhance reliability of diagnosis of dementia, thus access to support and treatment for people from an ethnic minority group experiencing memory problems.
Read more
Background
- The investigators are a group of staff from the Memory Assessment Service in Manchester. There are currently no suitable tests for dementia for people from Somalia.
- Research evidence tells us there are many reasons why the tools that used now are not working. This includes: differences in culture and ways of life that are very different to a British born person who has lived in the UK for all of their life.
- Somali people find out at a later stage if they have dementia resulting in delayed treatment/support.
- This research supports the government's promise to improve the pathway to a diagnosis of dementia for minority groups.
Design and methods
- 10 participants
- The investigators will compare the assessment tool (MSCAT) that the team have developed to the Addenbrookes Cognitive Examination III tool that is typically used.
- Participants will be seen at an agreed location (e.g. home, mosque or GMMH trust site). They will meet a Somali speaking researcher to do both tests on 2 appointments and discuss how they found the tests afterwards.
- The investigators will check participants understanding of the research before they agree to take part. Verbal and written information will be provided.
Public involvement
- The local Somali community helped advise on the creation of the new MSCAT assessment tool.
- The investigators will write project information for participants in Somali and English.
Dissemination of results
- Professional conference presentations and publications
- Conditions
- Dementia
- Being tested
- Manchester Somali Cognitive Assessment Tool, ACE-III Somali Translation
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manchester Somali Cognitive Assessment ToolDiagnostic test
Cognitive screen for dementia
ACE-III Somali TranslationDiagnostic test
Cognitive screen for dementia
| Study group | Role | What they receive |
|---|---|---|
| Participants | Somali migrants in UK, aged over 50. Receives: Diagnostic Test: Manchester Somali Cognitive Assessment Tool; Diagnostic Test: ACE-III Somali Translation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative feedback on completing the cognitive screens
Interview
Measured: Immediately after completing the screen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start8 Jan 2022
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Jeffery, Greater Manchester Mental Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163821
- Sponsor's protocol ID
- x503s
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a New Cognitive Assessment Tool for Detecting Dementia in the Migrant Somali Population
- ClinicalTrials.gov ID
- NCT05163821
- Acronym / sponsor ID
- x503s
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Greater Manchester Mental Health NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 20 Dec 2021 (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.
Aims
- The investigators want to find out if the tool that they have made to assess memory and thinking in Somali elders ( the 'MSCAT') is acceptable to that community and practical to administer and score.
- The public will benefit from this research because it seeks to enhance reliability of diagnosis of dementia, thus access to support and treatment for people from an ethnic minority group experiencing memory problems.
Background
- The investigators are a group of staff from the Memory Assessment Service in Manchester. There are currently no suitable tests for dementia for people from Somalia.
- Research evidence tells us there are many reasons why the tools that used now are not working. This includes: differences in culture and ways of life that are very different to a British born person who has lived in the UK for all of their life.
- Somali people find out at a later stage if they have dementia resulting in delayed treatment/support.
- This research supports the government's promise to improve the pathway to a diagnosis of dementia for minority groups.
Design and methods
- 10 participants
- The investigators will compare the assessment tool (MSCAT) that the team have developed to the Addenbrookes Cognitive Examination III tool that is typically used.
- Participants will be seen at an agreed location (e.g. home, mosque or GMMH trust site). They will meet a Somali speaking researcher to do both tests on 2 appointments and discuss how they found the tests afterwards.
- The investigators will check participants understanding of the research before they agree to take part. Verbal and written information will be provided.
Public involvement
- The local Somali community helped advise on the creation of the new MSCAT assessment tool.
- The investigators will write project information for participants in Somali and English.
Dissemination of results
- Professional conference presentations and publications
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: Manchester Somali Cognitive Assessment Tool, Diagnostic Test: ACE-III Somali TranslationSomali migrants in UK, aged over 50. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Somali-born migrants in UK
Key inclusion criteria (1 listed)
- The participants will all be Somali-born migrants, over the age of 50, living in the UK.
Key exclusion criteria (1 listed)
- Exclusion criteria will include the presence of dementia, current delirium, or inability to complete the tasks due to visual/hearing/physical 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 |
|---|---|---|
| Manchester Somali Cognitive Assessment ToolCognitive screen for dementia | Diagnostic test | Participants |
| ACE-III Somali TranslationCognitive screen for dementia | Diagnostic test | Participants |
Primary outcome
Qualitative feedback on completing the cognitive screens
Time frame: Immediately after completing the screen
Interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Greater Manchester Mental Health NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative feedback on completing the cognitive screens (time frame: Immediately after completing the screen). 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 18 Dec 2023.