CClinicalTrials.gg
RecruitingNCT05883527Updated Jun 1, 2023

Partnership in Safeguarding People With Dementia From Primary and Social Care Perspectives

An observational study in Dementia, Abuse Client and Neglect; Care, Malnutrition, sponsored by University of Manchester. Recruiting at 5 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-01.

Sponsored by University of Manchester · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 2 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dementia
  • Abuse Client
  • Neglect; Care, Malnutrition

Keywords

  • Safeguarding
  • Abuse
  • Neglect
  • Dementia
  • Health and care professionals
  • Social care
  • Section 42
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 50 is below the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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.

    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.

    Other: Not applicable as not an intervention - PLwD and family/carers

Interventions

  • OtherNot applicable as not an intervention - PLwD and family/carers

    Exploring the safeguarding process through interviews.

  • OtherNot applicable as not an intervention - HCP's

    Exploring the safeguarding process through interviews and a focus group.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: September 2022 - March 2024

  2. 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.

    Time frame: data years: 2002-2017

  3. 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.

    Time frame: data years: 2021-2022

Other outcomes

  1. Contexts, Mechanisms and Outcomes (CMO's) from the Rapid Realist Literature Review

    The rapid realist review will investigate how health \& social care professionals conceptualise and respond to risks of abuse and neglect involving people with dementia in England, UK. The review will be informed by Rameses guidelines and aims to develop initial programme theories.

    Time frame: September 2022 - March 2024

  2. Interpretative Phenomenological Analysis (IPA) of Interviews

    IPA of interview transcripts will lead to an in-depth understanding of the lived experiences of safeguarding from the perspective of health and social care professionals, people living with dementia, family caregivers and other relevant professionals.

    Time frame: September 2022 - March 2024

  3. Interpretative Phenomenological analysis (IPA) of Focus Group - with health and care professionals

    Lived experiences of safeguarding from the perspective of various professionals, including what worked, what did not work, understanding of legal thresholds, strategies for prevention and collaboration across agencies.

    Time frame: September 2022 - March 2024

07

Study locations

3 of 5 sites recruiting
  • CRN
    Leeds, United Kingdom
    • Emma Oughton · Contact
    Recruiting
  • Leeds Local Authority
    Leeds, United Kingdom
    • Annemarie Ulph · Contact
    Not yet recruiting
  • CRN
    Manchester, United Kingdom
    • Emma Oughton · Contact
    Recruiting
  • Greater Manchester Local Authority
    Manchester, United Kingdom
    • Tina Mallon · Contact
    Not yet recruiting
  • CRN
    Southport, United Kingdom
    • Emma Oughton · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05883527
Lead sponsor
University of Manchester
Responsible party
Reena Lasrado (Principal Investigator, University of Manchester) — Principal investigator
First posted
Jun 1, 2023
Start date
May 2023 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Jun 1, 2023

Study contacts

Katarzyna Szulewska
Contact
katarzyna.szulewska@manchester.ac.uk
01613067689
Reena Lasrado
Contact
reena.lasrado@manchester.ac.uk

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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