Piloting, psychometric testing and feasibility studies of adapted DIALOG+ in people with mild to moderate learning disability

ISRCTN	ISRCTN11440256
DOI	https://doi.org/10.1186/ISRCTN11440256
Integrated Research Application System (IRAS)	349711
Central Portfolio Management System (CPMS)	68145
National Institute for Health and Care Research (NIHR)	205440
Sponsor	North East London NHS Foundation Trust
Funder	NIHR Central Commissioning Facility (CCF)

Submission date: 27/06/2025
Registration date: 07/07/2025
Last edited: 16/04/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This research is part of the ICONIC programme, which aims to improve quality of life and behaviour that challenges in people with mild to moderate learning disability through person-centred solution focused communication. DIALOG+ is an evidence based, face-to-face intervention delivered by health professionals using a tablet, which structures routine care sessions to ensure that care planning is personalised, holistic and co-produced. DIALOG+ involves collaboratively completing a quality-of-life scale and then using those ratings to have a solution focused discussion in order to set actions and improve service user satisfaction. Studies have found that it can enhance the communication between service users and those who support them, and can improve quality of life in people with mental health problems, but it has not been used in people with learning disabilities. We want to make DIALOG+ accessible and suitable for people with learning disability and to use it to help individuals think about things in their life they want to improve (e.g. leisure activities, accommodation) by using resources available to them or their carers. Our aim is to test if it improves quality of life and behaviour.

Who can participate?
Piloting Study:
Service users will be eligible to take part if they are aged 18 or over, have mild or moderate learning disability based on service records/clinical notes, have a current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months), are living in any setting including the family home and supported living/ residential home, and can provide informed verbal or written consent.

Psychometric Testing Study:
Service users will be eligible to take part if they are aged 18 or over, have mild or moderate learning disability based on service records / clinical notes, are under community learning disability services from participating NHS trusts, and can provide informed verbal or written consent.

Comparison Testing Study:
Service users will be eligible to take part if they are aged between 18 and 65 years, are living in the community and are treated as out-patients by community psychiatric teams from participating NHS trusts, have a primary diagnosis of a mental health issue, and can provide informed verbal or written consent.

Clinical Services Feasibility Study:
Service users will be eligible to take part if they are aged 18 or over, have mild or moderate learning disability based on service records / clinical notes, have a current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months), are living in any setting including the family home and supported living/ residential home, and can provide informed verbal or written consent.

Care Homes Feasibility Study:
Service users will be eligible to take part if they are aged 18 or over, have mild or moderate learning disability based on service records / clinical notes, have a current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months), are residing in supported living or residential care, and can provide informed verbal or written consent.

What does the study involve?
Piloting Study:
In this study, we are interested in piloting an adapted version of the DIALOG scale and intervention (aDIALOG+) for people with learning disability. Five clinicians and five care workers will receive training on how to deliver aDIALOG+ and a copy of the manual, and an electronic tablet. They will then be asked to administer the aDIALOG+ intervention using the app (at least once) to two service users (20 in total). Following this we will invite clinicians, care workers and service users to take part in a focus group or interview to obtain feedback on what aspects of the intervention (including the DIALOG scale, app, training and manual) that worked well or did not work well, and suggestions for improvement. The focus groups/interviews will be audio-recorded and transcribed so that we can analyse the data and determine which aspects of the intervention that did not work well and require further modifications, which will inform changes to the intervention. We will also ask clinicians and care workers to complete a questionnaire for assessing intervention implementation processes from the perspective of professionals directly involved.

Psychometric Testing Study:
A clinical studies officer or a member of the research team will arrange a face-to-face or remote (via Teams or Zoom) meeting with 120 service users with learning disability, where they will be asked to complete the aDIALOG scale, along with additional questionnaires. Alternatively, service users can be sent the consent form and questionnaires to complete via email or post. Following this service users will be asked to complete the aDIALOG scale again on another occasion (ideally 24 hours later but no later than 1 week). This will be carried out face-to-face, online or via telephone, or alternatively service users can be sent the aDIALOG scale to complete again via email or post.

Comparison Testing Study:
A clinical studies officer or a member of the research team will arrange a face-to-face or remote (via Teams or Zoom) meeting with 200 service users with any mental health diagnosis (without learning disability) to complete the aDIALOG scale, along with the original DIALOG scale, and some demographic questions (e.g. gender, age, ethnicity, primary mental health diagnosis, how they receive their care and the number of years of treatment). Alternatively, service users can be sent the consent form and questionnaires to complete via email or post.

Clinical Services Feasibility Study:
In this study, we will be assessing whether it is feasible for clinicians to deliver an adapted version of aDIALOG+ to service users with mild or moderate learning disability who have behaviours that challenge (such as physical or verbal aggression towards others or property, temper tantrums / outbursts, and self-injurious behaviour). . Our aim is to establish whether it is possible to recruit 8-12 clinicians, 30 service users and 30 participant carers (if applicable) into the study. We will also examine the number of sessions of aDIALOG+ that are delivered over 6 months, the quality of the sessions, and the experiences and views of clinicians, service users and participant carers about the intervention, what worked well and what needs to be improved. We will also examine if there are any potential benefits of the intervention by looking at changes in outcome measures such as behaviour, community participation, quality of life and service use.

Care Homes Feasibility Study:
In this study, we will be assessing whether it is feasible for care workers to deliver an adapted version of DIALOG+ (aDIALOG+) to service users with mild or moderate learning disability who have behaviours that challenge (such as physical or verbal aggression towards others or property, temper tantrums / outbursts, and self-injurious behaviour).

What are the possible benefits and risks of participating?
For the piloting study, service users and care workers will receive a £20 shopping voucher for participating in the interview/focus group following the 6-week intervention period to thank them for their time, and service users will also receive a £20 voucher after taking part in the psychometric testing study. For the psychometric comparison study service users will receive a £10 voucher for taking part. For the clinical services and care homes feasibility studies, service users, participant carers and care workers will receive a £20 shopping voucher for completing qualitative interviews, and service users will receive £20 after completing the baseline assessment and £20 prior to the 6-month follow-up assessments to thank them for their time. Participant carers and care workers will also receive £20 following completion of the baseline assessment and prior to the 6-month follow-up assessments. By sharing experience and views on the aDIALOG+ software, it will help us to improve it and adapt it for clinicians and care workers who use aDIALOG+ in the future. We know that using the original DIALOG+ intervention improved the quality of life of people with psychosis when they used it face to face and we are hoping we can replicate those benefits in service users with learning disability.

Where is the study run from?
The research is coordinated at the Unit for Adult Mental Health and Wellbeing, Queen Mary University of London. Dr Afia Ali has overall responsibility for the study and it is sponsored by East London NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
The piloting study started in January 2026 and is expected to run for 3 months. The psychometric testing study started in July 2025 and is expected to run for 12 months. The comparison testing study is starting in May 2026 and is expected to run for 6 months. The clinical services and care homes feasibility studies are starting in April 2026 and are expected to run for 10 months.

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Dr Afia Ali (Chief Investigator)
afia.ali@qmul.ac.uk / afia.ali4@nhs.net
Miss Laura Miller (Programme Manager)
l.miller@qmul.ac.uk / laura.miller58@nhs.net

Contact information

Miss Laura Miller
Public, Scientific

Unit for Adult Mental Health and Wellbeing
Centre for Psychiatry and Mental Health (CPMH)
Wolfson Institute of Population Health
Queen Mary University of London
Yvonne Carter Building, 58 Turner Street
London
E1 2AB
United Kingdom

ORCID ID	0000-0001-8802-3554
Phone	+44 7352 980401
Email	l.miller@qmul.ac.uk

Dr Afia Ali
Principal investigator

ORCID ID	0000-0002-0104-9370
Phone	+44 7836 584017
Email	afia.ali@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional non-randomized
Secondary study design	Non randomised study
Scientific title	Improving quality of life and behaviour that challenges in people with mild to moderate intellectual disability through person-centred solution focused communication (ICONIC)
Study acronym	ICONIC
Study objectives	Current study objectives as of 16/04/2026: 1. To pilot the adapted DIALOG quality of life scale and intervention (aDIALOG+) and obtain feedback on what aspects of the intervention (including the aDIALOG scale, supporting app, training and manual) worked well or did not work well and suggestions for improvement. 2. To test the psychometric properties of the aDIALOG scale to establish whether the aDIALOG scale is a useful quality of life measure in people with learning disability, and to compare it with the original DIALOG scale in people with mental health issues. 3. To conduct a feasibility study of aDIALOG+ delivered by clinicians from community learning disability services to assess recruitment and retention of service users and clinicians. 4. To conduct a feasibility study of aDIALOG+ delivered by care workers from care homes (supported living or residential care) for people with learning disability to assess recruitment and retention of care homes, care workers and service users. Previous study objectives: 1. To pilot the adapted DIALOG quality of life scale and intervention (aDIALOG+) and obtain feedback on what aspects of the intervention (including the aDIALOG scale, supporting app, training and manual) worked well or did not work well and suggestions for improvement. 2. To test the psychometric properties of the aDIALOG scale to establish whether the aDIALOG scale is a useful quality of life measure in people with learning disability. 3. To conduct a feasibility study of aDIALOG+ delivered by clinicians from community learning disability services to assess recruitment and retention of service users and clinicians. 4. To conduct a feasibility study of aDIALOG+ delivered by care workers from care homes (supported living or residential care) for people with learning disability to assess recruitment and retention of care homes, care workers and service users.
Ethics approval(s)	Approved 23/06/2025, South West - Cornwall & Plymouth Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8079; cornwallandplymouth.rec@hra.nhs.uk), ref: 25/SW/0055
Health condition(s) or problem(s) studied	Mild to moderate intellectual disability
Intervention	Current interventions as of 16/04/2026: An adapted version of DIALOG+ (a brief, low-cost solution-focused intervention that improves the therapeutic effectiveness of routine clinical meetings between patients and clinicians) for individuals with learning disability will be piloted for 2-4 weeks, the adapted scale tested for psychometric properties at 2 timepoints (within 24 hours-1 week) and comparison tested with the original DIALOG scale, and delivered in clinical and care home feasibility studies for 6 months. Previous interventions: An adapted version of DIALOG+ (a brief, low-cost solution-focused intervention that improves the therapeutic effectiveness of routine clinical meetings between patients and clinicians) for individuals with learning disability will be piloted for 4-6 weeks, tested for psychometric properties at 2 timepoints (within 24 hours-1 week), and delivered in clinical and care home feasibility studies for 6 months.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcomes as of 16/04/2026: WP1a Piloting: 1. Acceptability of / feedback on the intervention is measured using semi-structured interviews / focus groups after 2-4 weeks. 2. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire after 2-4 weeks. WP1b Psychometric Testing: 1. Construct and concurrent validity of the aDIALOG scale are measured using the Mini-MANS LD and the WHOQOL Disabilities module and Clinical Outcome in Routine Evaluation- Learning Disability (CORE-LD), 14 item version (measure of psychological distress) at baseline. 2. Test re-test reliability of the aDIALOG scale is measured by completing the scale at baseline and again 24 hours to 1 week later. WP1b Comparison Testing: 1. Reliability of the aDIALOG scale through measuring the internal consistency and comparing to the original DIALOG scale. 2. Validity of the aDIALOG scale measured using evenness of distribution of scores compared to the original DIALOG scale and confirmatory factor analysis. Previous primary outcomes: WP1a Piloting: 1. Acceptability of / feedback on the intervention is measured using semi-structured interviews / focus groups with at 6 weeks. 2. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire at 6 weeks. WP1b Psychometric Testing: 1. Construct and concurrent validity of the aDIALOG scale are measured using the Mini-MANS LD and the WHOQOL Disabilities module and Clinical Outcome in Routine Evaluation- Learning Disability (CORE-LD), 14 item version (measure of psychological distress) at baseline. 2. Test re-test reliability of the aDIALOG scale is measured by completing the scale at baseline and again 24 hours to 1 week later. Feasibility studies: 1. Changes in behaviour in service users is measured using the Aberrant Behaviour Checklist (ABC) – Irritability subscale at baseline and 6 months
Key secondary outcome measure(s)	Feasibility studies: 1. Quality of life in service users is measured using the 13- item WHOQOL Disabilities module (WHOQOL-DIS) at baseline and 6 months 2. Community and Leisure participation in service users is measured using the Guernsey Community Participation and Leisure Assessment – Revised (GCPLA-R) at baseline and 6 months 3. Changes in psychological distress in service users is measured using the Learning Disability – Clinical Outcomes in Routine Evaluation, 14 item version (LD-CORE-14) at baseline and 6 months 4. Changes in the presence of psychiatric disorders in service users is measured using the Moss Psychiatric Assessment Schedule - Check (Moss-PAS Check) at baseline and 6 months 5. Changes in behaviour and functioning in service users as a result of the intervention is measured using a modified version of the Clinical Global Impressions Scale – Improvement version (CGI-I) at 6 months 6. Paid and family carer distress in participant carers is measured using the Kessler Psychological Distress Scale - K6 at baseline and 6 months 7. Changes in health-related quality of life in service users is measured using the EuroQol Five Dimensions - Learning Disability modified version of the EQ-5D-3L at baseline and 6 months. A proxy version of the EQ-5D-5L will also be completed by participant carers at baseline and 6 months. 8. Health related quality of life in participant carers is measured using the EQ-5D-5L at baseline and 6 months. 9. Health and social care contacts and medication in service users is measured using a modified version of the Client Services Receipt Inventory (CSRI) at baseline and 6 months. 10. Treatment costs of delivering the intervention are measured using staff time, room bookings and other resource use in participating clinical services and care homes. 11. Intervention implementation processes from the perspective of clinicians and care workers are assessed using the NoMAD questionnaire at 6 months. 12. Recruitment is measured using screening logs of the number of clinicians, care workers and eligible service users who were approached agreed to take part throughout the study at 6 months. 13. Retention is measured using withdrawal forms completed to record clinicians, care workers and service users who drop out of the study and the reasons why, as well as the number of participants that complete the follow-up assessment at 6 months. 14. Intervention adherence is measured using session completion data from the aDIALOG+ app at 6 months. 15. Intervention fidelity is measured using audio/video recordings of sessions, action plans from the aDIALOG+ app and completed session fidelity checklists at 6 months. 16. Acceptability of the intervention is measured using semi-structured interviews / focus groups with at 6 months.
Completion date	26/02/2027

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	502
Key inclusion criteria	Current inclusion criteria as of 16/04/2026: WP1a: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent WP1b Psychometric Testing: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Can provide informed verbal or written consent WP1b Comparison Testing: Service Users Inclusion Criteria: 1. Aged between 18 and 65 years 2. Living in the community and treated as out-patients by community psychiatric teams from participating NHS trusts 3. Have a primary diagnosis of a mental health issue 4. Can provide informed verbal or written consent WP2: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent WP3: Service Users Inclusion Criteria: 1. Aged 18 years or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, temper tantrums / outbursts, or damage to property in the last 3 months) 4. Residing in supported living or residential care 5. Can provide informed verbal or written consent Previous inclusion criteria: WP1a 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical aggression or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent 2. Clinicians Inclusion Criteria: 1. Aged 18 or over 2. Currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. From any profession (e.g. psychology, nursing, speech and language therapy, psychiatry, social work), grade 4 and above with a minimum of six months experience working with people with ID 4. Consent to participation 3. Care Workers Inclusion Criteria: 1. Aged 18 or over 2. Have worked in the care home for at least three months 3. Provide at least one day of support per week to service users 4. Consent to participation WP1b 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Can provide informed verbal or written consent WP2 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical aggression or damage to property in the last 3 months) 4. Living in any setting including the family home and supported living/residential home 5. Can provide informed verbal or written consent 2. Clinicians Inclusion Criteria: 1. Aged 18 or over 2. Currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. From any profession (e.g. psychology, nursing, speech and language therapy, psychiatry, social work), grade 4 and above with a minimum of six months experience working with people with ID 4. Consent to participation 5. Have not participated in other work packages 3. Participant Carers Inclusion Criteria: 1. Aged 18 or over 2. Are paid or unpaid (e.g. family carer); if a paid carer, need to have worked with the person for at least six months and should know the person well and support the person on a regular basis 3. Consent to participation WP3 1. Service Users Inclusion Criteria: 1. Aged 18 or over 2. Mild or moderate ID based on service records / clinical notes 3. Current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical aggression or damage to property in the last 3 months) 4. Residing in supported living or residential care 5. Can provide informed verbal or written consent 2. Care Homes Inclusion Criteria: 1. Supported living or residential placements for service users with ID in the participating areas 2. Service manager has agreed for the care home to take part 3. Care Workers Inclusion Criteria: 1. Aged 18 or over 2. Have worked in the care home for at least three months 3. Provide at least one day of support per week to service users 4. Consent to participation 5. Have not participated in other work packages
Key exclusion criteria	Current exclusion criteria as of 16/04/2026: WP1b Psychometric Testing: Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records/clinical notes 3. Not under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Unable to provide informed verbal or written consent WP1b Comparison Testing: 1. Under 18 years of age and over 66 years of age 2. Currently in an inpatient in a psychiatric hospital 3. Do not have a primary mental health diagnosis (e.g., substance misuse disorder) 4. Unable to provide informed verbal or written consent Previous exclusion criteria: WP1a 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Likely to move out of borough within the next 3 months or at imminent risk of hospital admission 4. Unable to provide informed verbal or written consent 2. Clinicians Exclusion Criteria: 1. Under 18 years of age 2. Not currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. Below grade 4 and less than 6 months experience working with people with ID 4. Do not consent to participation 3. Care Workers Exclusion Criteria: 1. Under 18 years of age 2. Have worked in the care home for less than 3 months 3. Do not provide at least one day of support per week to service users 4. Do not consent to participation WP1b 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Not under community ID services from the East London Foundation Trust - Updated 04/11/2025: from participating NHS trusts 4. Unable to provide informed verbal or written consent WP2 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Already participating in WP3 or involved in another clinical trial 4. Likely to move out of borough within the next 6 months or at imminent risk of hospital admission 5. Unable to provide informed verbal or written consent 2. Clinicians Exclusion Criteria: 1. Under 18 years of age 2. Not currently working within a community ID service, intensive support team or in a local authority or social care organisation for people with ID 3. Below grade 4 and less than 6 months experience working with people with ID 4. Do not consent to participation 5. Have participated in other work packages 3. Participant Carers Exclusion Criteria: 1. Under 18 years of age 2. If a paid carer and have worked with the person for less than six months and/or do not know the person well and/or support the person on a regular basis 3. Do not consent to participation WP3 1. Service Users Exclusion Criteria: 1. Under 18 years of age 2. Severe ID based on service records / clinical notes 3. Already participating in WP2 or involved in another clinical trial 4. Likely to move out of the care home within the next six months or are at imminent risk of hospital admission 5. Unable to provide informed verbal or written consent 2. Care Homes Exclusion Criteria: 1. Not supported living or residential placements for service users with ID and/or not in the participating areas 2. Service manager does not agree for the care home to take part 3. Care Workers Exclusion Criteria: 1. Under 18 years of age 2. Have worked in the care home for less than 3 months 3. Do not provide at least one day of support per week to service users 4. Do not consent to participation 5. Have participated in other work packages
Date of first enrolment	07/08/2025
Date of final enrolment	30/11/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

East London NHS Foundation Trust

Robert Dolan House
9 Alie Street
London
E1 8DE
England

Cornwall Partnership NHS Foundation Trust

Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
England

North London NHS Foundation Trust

Camden Learning Disability Service
5 Pancras Square
London
N1C 4AG
England

Cambridgeshire and Peterborough NHS Foundation Trust

Elizabeth House
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 1.0	30/05/2025	30/06/2025	No	No
Protocol file	version 3.0	14/10/2025	04/11/2025	No	No
Protocol file	version 5.0	02/04/2026	16/04/2026	No	No

Additional files

47564 ICONIC_ WP1 2 and 3 Protocol v1.0 30.05.2025.pdf: Protocol file
ISRCTN11440256_PROTOCOL_V3.0_14Oct2025.pdf: Protocol file
ISRCTN11440256_WP1 2 and 3_PROTOCOL_V5.0_02Apr2026.pdf: Protocol file

Editorial Notes

16/04/2026: The following changes were made to the study record:
1. Protocol uploaded.
2. The plain English summary of the protocol, study objectives, interventions, primary outcomes, inclusion/exclusion criteria, study participating centres and contact details were updated.
3. The target sample size was changed from 302 to 502.
4. The date of final enrolment was changed from 29/05/2026 to 30/11/2026.
04/11/2025: The following changes were made to the study record:
1. Protocol uploaded.
2. The plain English summary of the protocol, inclusion and exclusion criteria and study participating centres were updated.
3. The completion date was changed from 30/11/2026 to 26/02/2027.
4. The target number of participants was changed from 'Planned Sample Size: 282; UK Sample Size: 282' to 'Planned Sample Size: 302; UK Sample Size: 302'.
5. The date of first enrolment was changed from 31/07/2025 to 07/08/2025.
6. The date of final enrolment was changed from 31/03/2026 to 29/05/2026.
7. The intention to publish date was changed from 30/11/2027 to 26/02/2027.
27/06/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).