DementiaNCT05883527
Partnership in Safeguarding People With Dementia From Primary and Social Care Perspectives
An observational study of Dementia and Abuse Client, run by University of Manchester at 5 sites in United Kingdom.
Trial summary
"Adult safeguarding is everyone's responsibility". The Care Act 2014 makes safeguarding a legal duty. It provides local authorities and other agencies in England with a responsibility to protect adults with care and support needs from abuse and neglect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Abuse Client, Neglect; Care, Malnutrition
- What is being tested?
- Not applicable as not an intervention - PLwD and family/carers and Not applicable as not an intervention - HCP's
- How many people
- 37 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 May 2023to 31 Mar 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tentatively this study will aim to recruit 20-30 health and social care professionals (interviews-20, focus groups-10) making referrals via GP's who have experiences of safeguarding in the context of dementia. This study also aims to recruit between 15-20 people with dementia and carers/family members involved in safeguarding, who will be accessed via primary and social care practitioners.
Who may be able to join
- Health and social care professionals:
- GPs, Nurses, social workers, mental health professionals, support workers, IMCA (independent mental capacity advocates) and other health care professionals in GP surgeries and integrated social care hubs with experience in facilitating safeguarding.
- Safeguarding lead in GP surgeries, social care organisations and other organisations (advocacy agencies).
- Professionals from third-sector organisations who have previously raised safeguarding concerns regarding adults living with Dementia
- Service users and carers/family:
- People with dementia who have been involved in the safeguarding process, with mental capacity to consent.
- Family members of people with dementia who have been previously involved in the safeguarding process
- Individuals who were involved in a safeguarding inquiry in the past, which is NOT ongoing at the time of interview.
Who cannot join
- Health and social care professionals at GP practices, social care organisations and third sector organisations without experiences of safeguarding older adults and unwilling to participate in the study.
- People with dementia who lack capacity to consent.
- Individuals involved in an active and ongoing safeguarding inquiry.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
CRN
Leeds
Leeds Local Authority
Leeds
CRN
Manchester
Greater Manchester Local Authority
Manchester
CRN
Southport
About this study
"Adult safeguarding is everyone's responsibility". The Care Act 2014 makes safeguarding a legal duty. It provides local authorities and other agencies in England with a responsibility to protect adults with care and support needs from abuse and neglect. This is done most effectively when all relevant agencies work together. This is particularly important for people living with dementia, as they are at higher risk of abuse or neglect. Such abuse is most common in their own homes and care settings. Primary and social care professionals are likely to have regular contacts with older people, hence have opportunities for early identification and prevention of abuse. However, little is known about how primary care practitioners work in partnership with social care and other agencies to investigate and manage abuse.
Aims:
Read more
This project will outline how health professionals in primary care settings understand and respond to abuse and what their understandings of safeguarding law and policy are. It will also identify how social services departments assess and manage referrals relating to people living with dementia in primary care settings. Furthermore, the study will analyse the experiences of people with dementia and families who are at the centre of safeguarding
Methods:
This study has three phases. In phase 1, the investigators will synthesise current research and practice evidence to develop a theory of safeguarding conceptualisation and process. In phase 2, the investigators will analyse national statistics on safeguarding (NHS digital dataset), ageing and dementia data (English Longitudinal Study of Ageing) to understand patterns of reporting and how they vary across location, gender, ethnicity and time period. In phase 3, the investigators will interview GPs, social workers, safeguarding leads, independent advocates, people with dementia, family members, support workers, carers and other professionals who make or receive referrals via primary care. As part of phase 3 group discussions will also be conducted, in which professionals will come together to share their experiences, and will identify approaches for preventing abuse and collaboration amongst relevant agencies. Phase 3 will inform the development of complex case studies, drawing on data from phases 1 and 2.
Impact:
This study will help develop practice guidance for professionals, to aid multi-agency collaboration in safeguarding cases specific to dementia. This will be developed in consultation with the PPIE (Patient and Public Involvement and Engagement) members and practitioners. Videos will also be produced and plain English versions of case studies of complex safeguarding scenarios and strategies in consultation with safeguarding leads, law experts, training providers and other key stakeholders. Experts by experience (working with, caring for or living with dementia), will be able to guide the team with cultural nuances and appropriateness to ensure that the material developed is sensitive to all populations. An info graph/pictograph displaying signs of abuse, staying safe and what to do, aimed at people with dementia and family will be compiled. The investigators will liaise with national safeguarding leads so that this information can be displayed in GP clinics. Furthermore, the investigators will contact social responsibility personnel for supermarkets and discuss the potentials of wider circulation for displaying this information in stores.
- Conditions
- Dementia, Abuse Client, Neglect; Care, Malnutrition
- Being tested
- Not applicable as not an intervention - PLwD and family/carers, Not applicable as not an intervention - HCP's
- Keywords
- Safeguarding, Abuse, Neglect, Dementia, Health and care professionals, Social care, Section 42
- Medical subject headings
- Dementia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable as not an intervention - PLwD and family/carersOther
Exploring the safeguarding process through interviews.
Not applicable as not an intervention - HCP'sOther
Exploring the safeguarding process through interviews and a focus group.
| Study group | Role | What they receive |
|---|---|---|
| Health and Care Professionals | GP's, nurses, social workers, mental health professionals, support workers, Independent mental capacity advocates (IMCA), and other HCP's working in GP surgeries and integrated social care hubs. Safeguarding leads in GP surgeries, social care organisations and other relevant organisations. Professionals from third-sector organisations who have previous experience of safeguarding. Receives: Other: Not applicable as not an intervention - HCP's | |
| People Living with Dementia | Who have been involved in the safeguarding process and have capacity to consent. Receives: Other: Not applicable as not an intervention - PLwD and family/carers | |
| Paid carers of people living with dementia | Who have been involved in the safeguarding process. Receives: Other: Not applicable as not an intervention - PLwD and family/carers | |
| Family members of people living with dementia | Who have been involved in the safeguarding process. Receives: Other: Not applicable as not an intervention - PLwD and family/carers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trends in reporting of routinely collected safeguarding datasets - NHS digital
Number of reports of safeguarding concerns and section 42 enquiries in England. Type of risks, source of risks, location, age, gender, ethnicity, health condition.
Measured: September 2022 - March 2024
Trends in reporting of routinely collected safeguarding datasets - ELSA data
The prevalence of dementia across England, number of older people with dementia in receipt of care and who gave the care in each local authority in England.
Measured: data years: 2002-2017
Quality Outcomes Framework (QOF) Recorded Dementia Diagnoses
Rate of dementia diagnosis in each local authority district in England and demographic characteristics of those with dementia diagnosis in each NHS CCG in England.
Measured: data years: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 May 2023
- Primary completion6 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reena Lasrado, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883527
- Sponsor's protocol ID
- IRAS ID: 319897
- Status last verified
- Oct 2026
- First submitted
- 10 May 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maharani A, Dixon J, Szulewska K, Robinson C, Cooper M, Panagioti M, Blakeman T, Lasrado R. Geographical and temporal distribution of safeguarding concerns among older adults with dementia in England: a population-based repeated cross-sectional study. BMJ Open. 2026 Aug 26;16(8):e110575. doi: 10.1136/bmjopen-2025-110575.
PubMed 42648775Lasrado R, Szulewska K, Dixon J, Maharani A, Robinson C, Cooper M, Panagioti M, Blakeman T. Understanding Safeguarding for People Living with Dementia: A Realist Review of Conceptualization and Practice. Trauma Violence Abuse. 2025 Oct 21:15248380251375488. doi: 10.1177/15248380251375488. Online ahead of print.
PubMed 41117016
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership in Safeguarding People With Dementia From Primary and Social Care Perspectives
- ClinicalTrials.gov ID
- NCT05883527
- Acronym / sponsor ID
- IRAS ID: 319897
- Conditions
- Dementia, Abuse Client, Neglect; Care, Malnutrition
- Keywords
- Safeguarding, Abuse, Neglect, Dementia, Health and care professionals, Social care, Section 42
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Jun 2023 (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.
"Adult safeguarding is everyone's responsibility". The Care Act 2014 makes safeguarding a legal duty. It provides local authorities and other agencies in England with a responsibility to protect adults with care and support needs from abuse and neglect. This is done most effectively when all relevant agencies work together. This is particularly important for people living with dementia, as they are at higher risk of abuse or neglect. Such abuse is most common in their own homes and care settings. Primary and social care professionals are likely to have regular contacts with older people, hence have opportunities for early identification and prevention of abuse. However, little is known about how primary care practitioners work in partnership with social care and other agencies to investigate and manage abuse.
Aims:
This project will outline how health professionals in primary care settings understand and respond to abuse and what their understandings of safeguarding law and policy are. It will also identify how social services departments assess and manage referrals relating to people living with dementia in primary care settings. Furthermore, the study will analyse the experiences of people with dementia and families who are at the centre of safeguarding
Methods:
This study has three phases. In phase 1, the investigators will synthesise current research and practice evidence to develop a theory of safeguarding conceptualisation and process. In phase 2, the investigators will analyse national statistics on safeguarding (NHS digital dataset), ageing and dementia data (English Longitudinal Study of Ageing) to understand patterns of reporting and how they vary across location, gender, ethnicity and time period. In phase 3, the investigators will interview GPs, social workers, safeguarding leads, independent advocates, people with dementia, family members, support workers, carers and other professionals who make or receive referrals via primary care. As part of phase 3 group discussions will also be conducted, in which professionals will come together to share their experiences, and will identify approaches for preventing abuse and collaboration amongst relevant agencies. Phase 3 will inform the development of complex case studies, drawing on data from phases 1 and 2.
Impact:
This study will help develop practice guidance for professionals, to aid multi-agency collaboration in safeguarding cases specific to dementia. This will be developed in consultation with the PPIE (Patient and Public Involvement and Engagement) members and practitioners. Videos will also be produced and plain English versions of case studies of complex safeguarding scenarios and strategies in consultation with safeguarding leads, law experts, training providers and other key stakeholders. Experts by experience (working with, caring for or living with dementia), will be able to guide the team with cultural nuances and appropriateness to ensure that the material developed is sensitive to all populations. An info graph/pictograph displaying signs of abuse, staying safe and what to do, aimed at people with dementia and family will be compiled. The investigators will liaise with national safeguarding leads so that this information can be displayed in GP clinics. Furthermore, the investigators will contact social responsibility personnel for supermarkets and discuss the potentials of wider circulation for displaying this information in stores.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health and Care Professionals | – | Other: Not applicable as not an intervention - HCP'sGP's, nurses, social workers, mental health professionals, support workers, Independent mental capacity advocates (IMCA), and other HCP's working in GP surgeries and integrated social care hubs. Safeguarding leads in GP surgeries, social care organisations and other relevant organisations. Professionals from third-sector organisations who have previous experience of safeguarding. |
| People Living with Dementia | – | Other: Not applicable as not an intervention - PLwD and family/carersWho have been involved in the safeguarding process and have capacity to consent. |
| Paid carers of people living with dementia | – | Other: Not applicable as not an intervention - PLwD and family/carersWho have been involved in the safeguarding process. |
| Family members of people living with dementia | – | Other: Not applicable as not an intervention - PLwD and family/carersWho have been involved in the safeguarding process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tentatively this study will aim to recruit 20-30 health and social care professionals (interviews-20, focus groups-10) making referrals via GP's who have experiences of safeguarding in the context of dementia. This study also aims to recruit between 15-20 people with dementia and carers/family members involved in safeguarding, who will be accessed via primary and social care practitioners.
Key inclusion criteria (8 listed)
- Health and social care professionals:
- People with dementia who have been involved in the safeguarding process, with mental capacity to consent.
- Family members of people with dementia who have been previously involved in the safeguarding process
- Individuals who were involved in a safeguarding inquiry in the past, which is NOT ongoing at the time of interview.
Key exclusion criteria (3 listed)
- Health and social care professionals at GP practices, social care organisations and third sector organisations without experiences of safeguarding older adults and unwilling to participate in the study.
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 |
|---|---|---|
| Not applicable as not an intervention - PLwD and family/carersExploring the safeguarding process through interviews. | Other | Family members of people living with dementia, Paid carers of people living with dementia, People Living with Dementia |
| Not applicable as not an intervention - HCP'sExploring the safeguarding process through interviews and a focus group. | Other | Health and Care Professionals |
Primary outcome
Trends in reporting of routinely collected safeguarding datasets - NHS digital
Time frame: September 2022 - March 2024
Number of reports of safeguarding concerns and section 42 enquiries in England. Type of risks, source of risks, location, age, gender, ethnicity, health condition.
Trends in reporting of routinely collected safeguarding datasets - ELSA data
Time frame: data years: 2002-2017
The prevalence of dementia across England, number of older people with dementia in receipt of care and who gave the care in each local authority in England.
Quality Outcomes Framework (QOF) Recorded Dementia Diagnoses
Time frame: data years: 2021-2022
Rate of dementia diagnosis in each local authority district in England and demographic characteristics of those with dementia diagnosis in each NHS CCG in England.
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 26 Oct 2026.
- Results publication: PubMed 42648775Maharani A, Dixon J, Szulewska K, Robinson C, Cooper M, Panagioti M, Blakeman T, Lasrado R. Geographical and temporal distribution of safeguarding concerns among older adults with dementia in England: a population-based repeated cross-sectional study. BMJ Open. 2026 Aug 26;16(8):e110575. doi: 10.1136/bmjopen-2025-110575.
- Results publication: PubMed 41117016Lasrado R, Szulewska K, Dixon J, Maharani A, Robinson C, Cooper M, Panagioti M, Blakeman T. Understanding Safeguarding for People Living with Dementia: A Realist Review of Conceptualization and Practice. Trauma Violence Abuse. 2025 Oct 21:15248380251375488. doi: 10.1177/15248380251375488. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Abuse Client, run by University of Manchester at 5 sites 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 8 inclusion and 3 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Trends in reporting of routinely collected safeguarding datasets - NHS digital (time frame: September 2022 - March 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883527, which also lists 2 linked publications.
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 26 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.