Feasibility trial of the HOME intervention for staff in homelessness hostels supporting older residents with memory problems.
| ISRCTN | ISRCTN28374317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28374317 |
| IRAS number | 324735 |
| Secondary identifying numbers | IRAS 324735, Sponsor Ref 157693 |
- Submission date
- 09/08/2023
- Registration date
- 15/08/2023
- Last edited
- 24/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This study aims to test the feasibility and acceptability of a co-produced staff-focused intervention to support older people with memory problems living in hostel accommodations. This is aimed to be done in two phases; a pre-pilot study (Phase One) followed by a non-randomised multi-site feasibility trial (Phase Two).
Who can participate?
Participants will be homelessness hostel staff in participating hostel sites and residents with memory problems aged 50 years old and over.
What does the study involve?
In Phase One, a single pilot will be conducted of the co-produced six-session HOME intervention in one hostel over three months followed by a three-month ‘implementation period’. A focus group will be held at the end of the three-month HOME intervention and a brief semi-structured interview will be held with participating staff at 6 months. The intervention will be refined based on findings from the pilot.
In Phase Two, a non-randomised feasibility trial will be held of the six-session HOME intervention followed by a three-month implementation period to see if the intervention is feasible (if hostel staff and residents agree to take part and if we can collect necessary information) and acceptable (if people completed and liked the intervention). Feasibility and test procedures will be informed by collecting clinical and cost-effectiveness measures planned for a full trial at baseline and at six months from participating hostel staff and residents. Records will be kept of eligible referrals, consent, intervention attendance and losses to follow-up to inform intervention adherence and acceptability of measures. Qualitative interviews will be undertaken, with 8-10 hostel workers who received the intervention and their managers using a semi-structured interview guide and intervention sessions will be audio recorded to assess facilitator fidelity to the intervention. Information will be collected about how the intervention was delivered, how it was received and what people feel should be changed and how, if it proves useful, it could be rolled out. The study team will work with patient and public involvement representatives throughout the research process.
What are the possible benefits and risks of participating?
The study might not help but the information obtained might help to understand whether an intervention can help staff to better support people with memory problems experiencing homelessness. There are no risks foreseen to be associated with the study, although some topics discussed may be upsetting.
Where is the study run from?
The study is being run by University College London (UK)
When is the study starting and how long is it expected to run for?
January 2023 to January 2026
Who is funding the study?
The National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Penny Rapaport (Clinical Psychologist and study Chief Investigator), p.rapaport@ucl.ac.uk
Contact information
Principal Investigator
Division of Psychiatry
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0003-0479-6950 |
|---|---|
| Phone | +44 (0)207 679 9647 |
| p.rapaport@ucl.ac.uk |
Scientific
Division of Psychiatry
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
| Phone | +44 (0)207 679 9647 |
|---|---|
| p.rapaport@ucl.ac.uk |
Public
Research Assistant
Department of the mental health of older People
Division of Psychiatry
University College London
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
| Phone | None provided |
|---|---|
| G.Kidd@ucl.ac.uk |
Study information
| Study design | Non-randomized multi-site feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Assessing the feasibility and acceptability of a training and support intervention for homelessness hostel staff supporting older residents with memory problems: Work package 3 of HOME (Homeless, Older and experiencing MEmory problems) study. |
| Study acronym | HOME (Homeless, Older and experiencing MEmory problems) |
| Study hypothesis | Is the co-produced HOME staff intervention to support older people with memory problems living in homelessness hostel accommodation feasible and acceptable to deliver? |
| Ethics approval(s) |
Approved 14/06/2023, London - Camden & Kings Cross Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207104808; CamdenandKingsCross.REC@hra.nhs.uk), ref: 23/LO/0455 |
| Condition | Dementia or significant memory disorder |
| Intervention | The HOME intervention is a group-based training and support intervention for staff working in homelessness hostels supporting residents aged fifty and over with memory problems. The intervention comprises six sessions focused on: 1. Introduction to understanding memory problems 2. Communicating with people with memory problems 3. Trauma-informed understanding and managing distress behaviours and unmet needs. 4. Strategies to support functioning, meaningful interaction & harm minimisation 5. Understanding and assessing capacity and safeguarding 6. Keeping it going and developing individual and hostel-wide plans The training sessions will be followed by a three-month implementation period with supervision and troubleshooting for staff on putting learning into practice. This is a non-randomised trial therefore there is no control arm. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcomes for the feasibility trial will be: 1. The proportion of hostel staff participants adhering to intervention (attending at least 4/6 sessions) measured using an adherence log of staff participants attending each session at three months 2. The proportion of participating staff completing candidate primary outcome for a full trial at follow-up - Sense of Competence in Dementia Scale (SCIDS) or Maslach Burnout Inventory (MBI) at six months |
| Secondary outcome measures | 1. The proportion of participating older people for whom the potential primary outcome for the main trial is completed at follow-up measured using the EQ5D-5 level and the Disability Assessment for Dementia Scale (DADS) at six months 2. The estimated cost of delivering the intervention to inform their feasibility in a future full trial measured using the hourly cost of training and supervising facilitators; hours spent by facilitators delivering training and supervision in hostels; hours spent by staff engaging in the intervention; capital travel and materials costs; and numbers of residents supported. We will obtain staff costs from published sources and use the Client Services Receipt Inventory (CSRI) at baseline and six months 3. The acceptability of and fidelity to the intervention measured using a mixed methods process evaluation; acceptability will be measured by focus groups at three months and individual qualitative interviews at six months; fidelity will be assessed using checklists applied independently to transcribed audio recordings of the training sessions by two researchers to assess intervention acceptability and required refinements at three and six months post-intervention |
| Overall study start date | 01/01/2023 |
| Overall study end date | 31/01/2026 |
Eligibility
| Participant type(s) | Employee, Service user |
|---|---|
| Age group | Senior |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | 88 |
| Participant inclusion criteria | Hostel staff: 1. 18 years or older 2. Providing direct support to some residents with memory problems 3. Working any weekday, daytime shifts 4. Willing and able to give written or audio-recorded informed consent 5. Able to understand spoken English Hostel residents: 1. Aged 50 years or over 2. A recorded diagnosis of dementia 3. A score of ≥2/6 on the Noticeable Problems Checklist proxy measure (indicative of significant memory disorder) |
| Participant exclusion criteria | 1. Staff planning on leaving work within the hostel within six months 2. Residents with memory problems known to be moving on within the next three months |
| Recruitment start date | 24/08/2023 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
London
WC1X 8QY
United Kingdom
Tower Hill
London
E1W 1YW
United Kingdom
London
SE5 8UA
United Kingdom
Bethnal Green
London
E2 6HD
United Kingdom
London
SW1P 2BT
United Kingdom
Sponsor information
University/education
Joint Research Office
1st Floor, Maple House (Suite B)
149 Tottenham Court Road
London
W1T 7BN
England
United Kingdom
| Phone | +44 (0)20 7679 9647 |
|---|---|
| uclh.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Findings will be disseminated in peer-reviewed journals; develop policy briefings and present findings in appropriate local forums for health and social care professionals and at national and international conferences; participants who have indicated they are interested in reading the final paper will be sent it. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Dr Penny Rapaport (p.rapaport@ucl.ac.uk). The types of data that will be shared are quantitative outcome data from baseline and six-month follow-up for staff and resident participants and anonymised qualitative data from focus groups and interviews with staff. These data will be available upon completion of the study. All participants will give informed consent (or if participants with memory problems lack capacity a consultee will consent on their behalf) to participate in the study. There is an optional box on the consent form for future data sharing. All qualitative and quantitative data will be fully anonymised before sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 0.2 | 11/04/2023 | 15/08/2023 | No | No |
Additional files
Editorial Notes
24/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2025 to 31/07/2025.
2. The overall end date was changed from 01/08/2025 to 31/01/2026.
3. The intention to publish date was changed from 01/03/2026 to 30/09/2026.
4. The plain English summary was updated to reflect these changes.
21/02/2024: The intention to publish date was changed from 01/02/2024 to 01/03/2026.
15/08/2023: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
