ISRCTN ISRCTN65120935
DOI https://doi.org/10.1186/ISRCTN65120935
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Integrated Research Application System (IRAS) 329360
Protocol serial number IRAS 329360, NIHR205704
Sponsor University of Sunderland
Funder National Institute for Health and Care Research
Submission date
25/06/2024
Registration date
11/07/2024
Last edited
18/11/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Adult safeguarding was developed to prevent and protect “adults at risk” (AAR) from abuse and neglect, but it lacked a person-centred approach. Under the Care Act 2014 an initiative called Making Safeguarding Personal was developed to address this issue, but challenges remain. "Adults at risk" are people aged over 18 years who are at risk of abuse and neglect because of their care and support needs and older people (aged 65+ years) are the most highly represented adults at risk. Studies have highlighted issues with Making Safeguarding Personal, including:
1. Lack of professional understanding;
2. Limited research which includes the voices of older people; and
3. Limited understanding of the concept of safety.
The aim of this research is to improve adult safeguarding for older adults by addressing gaps in the understanding and implementation of Making Safeguarding Personal for older adults. This will be achieved through an in-depth understanding of the perspectives and experiences of older people, family members, and social care leaders and practitioners.

Who can participate?
Participants will include adults over the age of 65 years who have care and support needs and those who have experienced adult safeguarding enquiries. It will also include family members of older people who have adult safeguarding experiences, as well as advocates and social workers who have practice experience in this area.

What does the study involve?
The research will use arts-based methods to explore the concept of safety with older adults who have care and support needs. Semi-structured interviews will be conducted with older adults at risk who have experienced adult safeguarding, as well as family members, to gain a deeper understanding of their experiences. Additionally, interviews will be conducted with advocates and social workers to examine adult safeguarding practice. Focus groups with social workers and co-production events will bring together various stakeholders (including chairs and business managers for Safeguarding Adults Boards, representatives from advocacy services, social workers, older AAR, and family members) to discuss the research findings and collaboratively develop responses.

What are the possible benefits and risks of participating?
DIscussing this topic may be distressing or challenging for some participants. The researchers will support participants to be involved and will signpost to additional support for all participants. By taking part in the study participants will support the researchers to develop adult safeguarding and improve responses. Practitioners who participate may be able to use their involvement in the research as part of their CPD record.

Where is the study run from?
University of Sunderland (UK)

When is the study starting and how is it expected to run for?
May 2024 to April 2027

Who is funding the study?
NIHR Research for Patient Benefit (Research for Social Care call): NIHR205704 (UK)

Who is the main contact?
Dr Sarah Lonbay, sarah.lonbay@sunderland.ac.uk

Contact information

Dr Sarah Lonbay
Public, Scientific, Principal investigator

Faculty of Education and Society
Wearside View
Sir Tom Cowie Campus
Sunderland
SR60DD
United Kingdom

ORCiD logoORCID ID 0000-0002-5122-9505
Phone 07811770678
Email sarah.lonbay@sunderland.ac.uk

Study information

Primary study designObservational
Study designQualitative study across multiple sites
Secondary study designQualitative research
Participant information sheet ISRCTN65120935_PIS_WP1 Stage 2 (b) V2 Older people.pdf
Scientific titleSafeguarding adults for empowerment (SAFE): a qualitative study to develop best practice for involving older people in safeguarding processes
Study acronymSAFE
Study objectivesResearch question: How can the understanding and implementation of Making Safeguarding Personal be improved to enhance adult safeguarding (AS) for older people?
Ethics approval(s)

Approved 24/09/2024, West Midlands - Coventry and Warwickshire Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; coventryandwarwick.rec@hra.nhs.uk), ref: 24/WM/0165

Health condition(s) or problem(s) studiedResponses to abuse and neglect - adult safeguarding
InterventionWork package 1 (WP1) (stage 1): Participants will be older people (65+ years) (n = 24-32). This WP will develop the evidence base on how safety is perceived and experienced by older people with care and support needs.

WP1 (stage 2): Participants will be older adults at risk who have experienced adult safeguarding (65+ years) (n = 15-20). Semi-structured interviews will be used to explore participants’ lived experiences of being involved in adult safeguarding.

WP2: Participants will be family members of older adults at risk (n = 15-20) who have been through AS. Semi-structured interviews will cover participants’ experiences of supporting an older family member through adult safeguarding.

WP3 (stage 1): Participants will be advocates and social workers. Semi-structured interviews will explore adult safeguarding practice experience.

WP3 (stage 2): Participants will be social workers. Focus groups will explore practitioners’ responses to the data and be used to co-produce outputs for the study.

WP 4: Co-production events. Attended by chairs and business managers for Safeguarding Adults Boards (SABs), representatives from advocacy services, social workers, older adults at risk (AAR), and family members. The events will support the dissemination of key findings and co-production of practice guidance and toolkit for adult safeguarding practice.
Intervention typeOther
Primary outcome measure(s)

This research will explore older people's views about safety and will also explore older adults at risks, family members, and practitioners views and experiences of adult safeguarding enquiries. This will be undertaken through arts-based research, semi-structured interviews, and focus groups. Data will be explored using a deductive-inductive thematic analysis.

Key secondary outcome measure(s)

There are no secondary outcome measures

Completion date30/04/2027

Eligibility

Participant type(s)Employee, Service user, Other
Age groupMixed
Lower age limit21 Years
Upper age limit110 Years
SexAll
Target sample size at registration120
Key inclusion criteriaWP1 (stage 1):
Participants will be older people (65+ years)

Inclusion:
1: Over the age of 65 years
2: Has care and support needs (regardless of whether these are currently being met by services or whether they meet eligibility criteria)
3: Has capacity to consent to participate
4: All literacy levels
5: Presence or absence of learning disability

WP1 (stage 2):
Participants will be older adults at risk (65+ years)

Inclusion:
1: Over the age of 65 years
1: Meets the criteria for an adult at risk and has had experience of AS processes post Care Act 2014
3: The AS process is concluded
4: Presence or absence of learning disability
5: Has capacity to consent to take part in the research

WP2: Participants will be family members of older adults at risk who have been through AS.

Inclusion:
1: Has a family member who has been through an AS process (post Care act 2014)
2: That family member was over the age of 65 years when they experienced the AS process
3: Was actively involved in supporting their family member within that process, including in cases where the family member did not have capacity to make decisions about the AS enquiry
4: Has the capacity to consent to take part in the research

WP3: Participants will be advocates and social workers.

Inclusion:
1: Works or has recently worked in one of the partner local authorities
2: Has direct practice experience of working with older people in AS (under the Care Act 2014), including working with older adults in AS who lacked the capacity to make decisions relating to the adult safeguarding enquiry
Key exclusion criteriaAny potential participant who does not meet the criteria for one of the groups detailed above will be excluded from the research
Date of first enrolment08/10/2024
Date of final enrolment30/09/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Sunderland
Chester Road
Sunderland
SR1 3SD
England

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 2 18/11/2025 No Yes
Participant information sheet version 2 18/11/2025 No Yes
Participant information sheet version 2 18/11/2025 No Yes

Additional files

ISRCTN65120935_PIS_WP1 Stage 2 (b) V2 Older people.pdf
Participant information sheet
ISRCTN65120935_PIS_WP2 V2 Family members.pdf
Participant information sheet
ISRCTN65120935_PIS_WP3 V2.pdf
Participant information sheet

Editorial Notes

18/11/2025: Participant information sheets added.
09/10/2024: HRA ethics approval was added and the recruitment start date was changed from 01/10/2024 to 08/10/2024.
28/06/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).