Virtual Engagement Rehabilitation Assistant (VERA) in the community
| ISRCTN | ISRCTN47443045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47443045 |
| IRAS number | 330807 |
| Secondary identifying numbers | CPMS 65108, NIHR153944 |
- Submission date
- 23/01/2025
- Registration date
- 05/03/2025
- Last edited
- 11/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
The Virtual Engagement Rehabilitation Assistant (VERA) is a new digital tool designed to help patients with their rehabilitation goals. VERA provides access to personalized resources like exercise videos, appointment reminders, well-being questionnaires, and more. This study aims to evaluate how well VERA works in community rehabilitation settings for people with neurological conditions.
Who can participate?
Up to 20 patients receiving neurological community rehabilitation will be invited to participate. Additionally, up to 20 staff members from the rehabilitation teams will also be invited to take part.
What does the study involve?
Participants will use VERA on an iPad for up to six weeks as part of their rehabilitation. They will receive training on how to use VERA and will have access to personalized resources provided by their rehabilitation team. Data collected will include demographic information, health and well-being measures, and feedback on the VERA training. At the end of the six weeks, participants will take part in a semi-structured interview.
What are the possible benefits and risks of participating?
Participants may benefit from having easy access to personalized rehabilitation resources, which could support their recovery. There are minimal risks involved, mainly related to the time commitment required for training and using VERA.
Where is the study run from?
The study is being conducted by the University of Central Lancashire in collaboration with the Lancashire and South Cumbria Foundation Trust and Liverpool University Hospitals Foundation Trust.
When is the study starting and how long is it expected to run for?
February 2024 to January 2026
Who is funding the study?
NIHR Health Technology Assessment programme (UK)
Who is the main contact?
Dr Kathryn Jarvis, KJarvis1@uclan.ac.uk
Contact information
Public, Scientific, Principal Investigator
University of Central Lancashire, Brook Building Room 247
Preston
PR1 2HE
United Kingdom
 ORCID ID |
0000-0001-5963-7346 |
|---|---|
| Phone | +44 1772 892782 |
| KJarvis1@uclan.ac.uk |
Study information
| Study design | Interventional non-randomised qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life, Treatment |
| Participant information sheet | 46724 VERA PIS Service User V3 (14-12-24).pdf |
| Scientific title | Acceptability and usability of the Virtual Engagement Rehabilitation Assistant (VERA) for community-based neurological rehabilitation |
| Study acronym | VERA in the community |
| Study objectives | The objectives are: 1. To identify and engage with Virtual Engagement Rehabilitation Assistant (VERA) stakeholders in a community-based setting. 2. To complete the Health Equalities Assessment Tool in collaboration with community stakeholders and undertake identified actions to promote equality of access to and use of VERA during the intervention. 3. To review, prioritise and undertake changes identified in the first VERA (inpatient setting) study to refine the VERA Intervention in preparation for the current study. 4. To utilise findings from Work streams 1 and 2 to modify the VERA Intervention for a community-based neurorehabilitation setting. 5. To implement the VERA Intervention in two community-based neurological rehabilitation services. |
| Ethics approval(s) |
Approved 03/12/2024, North West - Preston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; preston.rec@hra.nhs.uk), ref: 24/NW/0321 |
| Health condition(s) or problem(s) studied | Neurological rehabilitation |
| Intervention | Following consent, and collection of demographic information, service users will be invited to take part in the following: 1. Training to learn how to use VERA. 2. Completion of a questionnaire (approximately 10 minutes top complete) to help explore their response to this training 3. Completion of six quantitative measures before using VERA (approximately 35 minutes to complete all six questionnaires): Short-form 36 (SF-36), Patient Health Questionnaire-9 (PHQ-9), Perceived Health Competence Scale (PHCS), Six Item Cognitive Impairment Test (6-CIT), Occupational Self-assessment-Short-form (OSA-SF), Modified Rankin Score (MRS) 4. Use of a VERA Unit for up to six weeks to use within their rehabilitation. 5. On completion of the use of VERA, an interview of up to 60 minutes, which will be conducted online, or face-to-face if this is preferred. 6. Completion of the six quantitative measures after using VERA: SF-36, PHQ-9, PHCS,6-CIT, OSA-SF, MRS. 7. Debrief In addition, clinical staff will provide the number of goals set and completed by each participating service user during their time with a VERA Unit. Usage data will also be collected. Staff working with the service users who have been allocated a VERA Unit will be invited to participate in the study. Up to 10 staff participants from each community neurological rehabilitation service will, following consent and collection of demographic information, will be invited to undertake the following: 1. Training to learn how to use VERA. 2. Completion of a questionnaire to help explore their response to this training 3. Contribute to a focus group of up to 90 minutes (one for each community neurological rehabilitation service). The Focus Group Discussion will be conducted face-to-face if infection control measures and research partner protocols enable face-to-face focus groups. Otherwise they will be conducted online. These groups will take place at a time and venue convenient to the staff. |
| Intervention type | Other |
| Primary outcome measure | A framework analysis (Ritchie and Spencer 1994) will be used to analyse the data collected 1. Qualitative component: Exploration of the acceptability, feasibility and usability, and information about who may gain benefit/disbenefit from VERA measured using training questionnaires, service-user interviews and the staff focus groups during the intervention 1.1. Experience of receiving training to use VERA 1.2. Experiences of using VERA 1.3. Facilitators and barriers to using VERA 2. Qualitative component: Overall total number of minutes of VERA usage recorded at 6 weeks; Timepoint(s): Post-intervention (6 weeks) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/02/2024 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Key inclusion criteria | Service user participants will be eligible for inclusion if they: 1. are receiving, or are on a waiting list to receive, rehabilitation to address the impact of a neurological condition. 2. have rehabilitation goals that a therapist identifies can be addressed through the VERA intervention. 3. have communication that supports effective use of the VERA Unit, either independently or with additional equipment/support. Where an individual has a communication impairment, this will be assessed by a speech and language therapist. 4. are able to understand written English language, or have daily access to someone to offer translation support, as VERA is currently only available in the English language. Staff participants will be included if they: 1. are a member of the allied health professional staff, either a qualified professional or staff working in a support role. 2. have worked in their professional capacity with service users who have been allocated a VERA Unit during the implementation phase. |
| Key exclusion criteria | Service users will be excluded if they: 1. do not have mental capacity to engage in the study. This will be assessed through discussion between the service user, the clinical team and the researchers and, where permission is given, with participant-identified family and friends. This discussion will be based on the five principles of the Mental Capacity Act 2005 Code of Practice (Department for Constitutional Affairs 2007). Individuals will be provided with every support possible to consider their involvement in the study (and their subsequent use of VERA) and to make a decision based on the information provided. 2. are under 18 years of age. Staff participants will be excluded if they: 1. spend less than seven hours a week working with service users within the community neurological rehabilitation service. 2. are under 18 years of age. |
| Date of first enrolment | 21/07/2025 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor information
University/education
Clayton's Gate
Preston
PR1 2HE
England
United Kingdom
| Phone | +44 1772895583 |
|---|---|
| irassponsor@uclan.ac.uk | |
| Website | https://www.uclan.ac.uk |
"ROR" |
https://ror.org/010jbqd54 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | On completion of the study, all efforts will be made to publish the findings, which will ensure the information is available in a peer-reviewed journal. It will be possible to access the Executive Summary of the full study report by contacting the Chief Investigator. It will also be available on the VERA website and will be stored on the University of Central Lancashire Online Knowledge (CLoK) repository, to enable open access. In a debrief at the end of the study, service user participants will be advised how they can access the Executive Summary. They will also be asked if they would like to be involved in dissemination opportunities, including conference presentations. Where a participant indicates interest, they will be asked to supply an email address or telephone number to enable future contact. A lay summary of the findings will be available after completion of the study. All patient participants will be informed of this via the Participant Information Sheet and Debrief, and will have the option to consent to receive this by email in due course. |
| IPD sharing plan | The anonymised, analysis of the interviews and focus groups during the current study will be available upon request from Kathryn Jarvis: KJarvis1@uclan.ac.uk. This analysis will be available once the Executive Summary has been published. We do not have consent from participants to share data for other research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Service user version 3 |
14/12/2024 | 04/03/2025 | No | Yes |
| Participant information sheet | Staff version 3 |
14/12/2024 | 04/03/2025 | No | Yes |
| Protocol file | version 3 | 14/12/2024 | 04/03/2025 | No | No |
Additional files
Editorial Notes
11/07/2025: The date of first enrolment was changed from 01/05/2025 to 21/07/2025.
10/04/2025: The following changes were made:
1. The overall study end date was changed from 31/07/2025 to 31/01/2026.
2. The recruitment end date was changed from 31/07/2025 to 31/10/2025.
23/01/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
