Condition category
Not Applicable
Date applied
13/01/2020
Date assigned
17/01/2020
Last edited
17/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims.
This study is an anonymous online survey to establish patient and public views on the sharing of identifiable health data for clinical purposes, and de-identified health data for research within the UK. By health data we mean any information collected about a person’s health, including things like medical notes, blood test results, etc. This may have personal information such as names and addresses attached (identifiable), or personal information removed (de-identified). Currently there is only limited sharing of health data for clinical purposes via implicit consent across the NHS. Recent reviews of public attitudes to using patient health data for research found little research about how acceptable it is to share patient health data for groups with specific health conditions, and that sharing some types of sensitive data (on mental health, sexual health, sexuality, religion, etc.) held greater concern than for other types of data. This study seeks opinions on whether the public holds different views about the sharing of mental versus physical health data, and, in the context of research, about structured versus “free text” de-identified data. It will also seek views about a national consent form, about data linkage for research, and about a national web portal to sign up to be contacted about health research. The study aims to recruit >1000 people over 6 months.

Who can participate?
The survey is open to anyone residing in the UK over the age of 16 (or under 16 with parental permission) who can access the online survey.

What does the study involve?
Completing an online survey. The survey takes about 18-25 minutes to complete but does not have to be completed in one sitting. It does ask questions about the respondent’s own physical and mental health, and some personal demographics, but all questions have a “prefer not to answer” choice.

What are the possible benefits and risks of participating?
There are potential future benefits to others via the research, but no direct benefits to participants. No risks to participants are anticipated.

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

When is the study starting and how long is it expected to run for?
March 2019 to December 2020

Who is funding the study?
Medical Research Council (MRC) (UK)

Who is the main contact?
Mrs Linda Jones
laj28@cam.ac.uk

Trial website

https://www.climbproject.org.uk/

Contact information

Type

Scientific

Primary contact

Dr Rudolf Cardinal

ORCID ID

http://orcid.org/0000-0002-8751-5167

Contact details

Chief Investigator
Department of Psychiatry
University of Cambridge
Behavioural and Clinical Neuroscience Institute
Sir William Hardy Building
Downing Site
Cambridge
CB2 3EB
United Kingdom
+44 (0)1223 768501
rnc1001@cam.ac.uk

Type

Public

Additional contact

Mrs Linda Jones

ORCID ID

Contact details

Study Co-ordinator
University of Cambridge
Department of Psychiatry
Behavioural and Clinical Neuroscience Institute
Sir William Hardy Building
Downing Site
Cambridge
CB2 3EB
United Kingdom
+44 (0)1223 764670
laj28@cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44205, IRAS 268811

Study information

Scientific title

University of Cambridge NHS health data consent survey

Acronym

Study hypothesis

Null hypotheses include:
1. The public's views on sharing mental health data will not differ from their views regarding physical health data
2. Their views on sharing will be uninfluenced by recipient type (e.g. NHS, academia, commercial researchers), or their own situation (demographics, experience of mental/physical health services)
3. Their views on sharing structured (coded) data for research will not differ from those on sharing de-identified free-text (narrative) data

Ethics approval

Approved 20/12/2019, East of Scotland Research Ethics Service (Tayside Medical Science Centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9S, UK; Tel: +44 (0)1382 383878; Email: eosres.tayside@nhs.net), REC ref: 19/ES/0144

Study design

Observational; Design type: Cross-sectional

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Internet

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Health data sharing

Intervention

This study is an anonymous online survey to establish patient and public views on the sharing of identifiable health data for clinical purposes, and de-identified health data for research within the UK. Currently, there is limited sharing of health data for clinical purposes via implicit consent across the National Health Service (NHS; HSC in Northern Ireland). Recent literature reviews of public attitudes to using patient health data for research noted there were few studies relating to the acceptability of sharing patient health data for groups with specific health conditions, and that sharing some types of sensitive data (on mental health, sexual health, sexuality, religion, etc.) held greater concern than for other types of data.

In conjunction with the study team's research advisory group, made up of mental health service users and carers, an online survey has been designed to seek public views on data sharing across the UK and the design of a unified consent form. The survey has been thoroughly tested by members of the public, both with and without mental health conditions.

Participants living in the UK will be invited to take part in the survey through advertising leaflets, posters and postcards as well as messages for social media. The study team also hope to use the NHS National Institute for Health Research (NIHR) Clinical Research Network (CRN) to reach out across the UK. The team will engage with other MRC MHDP-funded university sites and UK charities to promote the survey. Local media (radio, TV, and written) will be approached with the hope that it may gain some national coverage. The study team also have contacts in other hospitals and universities across the UK. ‘Pop-ups’ in towns and cities may be used, as well as stands at local and national events.

Participants will enter, consent, and complete the survey online (pilot work indicates that this takes 18-25 minutes). There is no contact from the University of Cambridge study team to the participants, unless they wish to receive the results of the survey or contact the study team directly themselves. Once the survey has been completed by the participant, their involvement in the study ends.

For one question in the survey, the team have superimposed a randomised intervention, namely a framing statement, prior to seeking views relating to the sharing of mental versus physical health data. The framing statement will be one of three: a "security" framing emphasising previous work reporting others' greater concerns about sharing mental health data versus other kinds of health data; a "neutral" statement; and a "holistic" framing emphasising the interrelationship between mental and physical illness. Randomisation to the three framing statements will be in a 1:1:1 ratio, without stratification.

The study team hope to complete the survey over 6 months with an aim to produce the final report within 3 months of the study closing.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Views on how health data may be shared across the UK, how these are related to demographic variables, and how opinions on sharing mental versus physical health data are affected by the framing of risk versus benefit. All preferences in relation to data sharing will be measured using Likert-style scales, yielding interval/ordinal data on preferences (e.g. "very unlikely to share"/"strongly disagree" through to "very likely to share"). Self-reported overall degree of support for:
1. Sharing physical health data for NHS clinical care without explicit consent each time, and how far such sharing should extend
2. Likewise for mental health data
3. Sharing de-identified structured physical health data for research without explicit consent, and how far such sharing should extend (e.g. NHS, academic, charities, industry, publicly)
4. Likewise for mental health data
5. As for 3 but with de-identified free text data
6. As for 4 but with de-identified free text data
Measured using an online survey at a single timepoint

Secondary outcome measures

Views on the design of a national consent form and on whether there should be a separate national web portal for mental health research as well as views on data linkage. Secondary measures will include:
1. The effect of the framing interventions
2. The degree of support for a single national sign-up mechanism for sharing one's health data for clinical care and/or research
3. Views on a prototype national NHS data sharing consent form
4. Views on trusted-third-party linkages between health data and a range of other UK state-held data sources (e.g. education, criminal justice)
Measured using an online survey at a single timepoint

Overall trial start date

01/03/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Participant currently resides in the UK
3. Participant is able to access the online survey

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1266; UK Sample Size: 1266

Participant exclusion criteria

Under 16 years of age without parent or guardian permission (the researchers have put 8 as a lower age limit as one is required; they would not wish to exclude anyone with parental permission on the basis of age but the numbers of participants < 16 is likely to be very low)

Recruitment start date

21/01/2020

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House Fulbourn Hospital Cambridge Road Fulbourn
Cambridge
CB21 5EF
United Kingdom

Trial participating centre

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Royal Bournemouth General Hospital Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

North Staffordshire Combined Healthcare NHS Trust
Bellringer Road Trentham
Stoke-On-Trent
ST4 8HH
United Kingdom

Trial participating centre

North Staffordshire Combined Healthcare NHS Trust
Bellringer Road Trentham
Stoke-On-Trent
ST4 8HH
United Kingdom

Trial participating centre

Norfolk and Suffolk NHS Foundation Trust
Hellesdon Hospital Drayton High Road
Norwich
NR6 5BE
United Kingdom

Trial participating centre

Salisbury NHS Foundation Trust
Salisbury District Hospital Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Kent and Medway NHS and Social Care Partnership Trust
Farm Villa Hermitage Lane
Maidstone
ME16 9PH
United Kingdom

Trial participating centre

Sherwood Forest Hospitals NHS Foundation Trust
Mansfield Road
Sutton-In-Ashfield
NG17 4JL
United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Royal Cornwall Hospital Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Worcestershire Acute Hospitals NHS Trust
Worcestershire Royal Hospital Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Trial participating centre

Worcestershire Health and Care NHS Trust
Isaac Maddox House Shrub Hill Industrial Estate
Worcester
WR4 9RW
United Kingdom

Trial participating centre

Airedale NHS Foundation Trust
Airedale General Hospital Skipton Road Steeton
Keighley
BD20 6TD
United Kingdom

Trial participating centre

Taunton and Somerset NHS Foundation Trust
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Mailpoint 18 Southampton General Hospital Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Somerset Partnership NHS Foundation Trust
2nd Floor Mallard Court Express Park Bristol Road
Bridgwater
TA6 4RN
United Kingdom

Trial participating centre

Dorset Healthcare University NHS Foundation Trust
Sentinel House 4-6 Nuffield Road Nuffield Industrial Estate
Poole
BH17 0RB
United Kingdom

Trial participating centre

University Hospitals Plymouth NHS Trust
Derriford Hospital Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Trust HQ, PO Box 9551 Queen Elizabeth Medical Centre Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Dudley and Walsall Mental Health Partnership NHS Trust
Trafalgar House 47-49 King Street
Dudley
DY2 8PS
United Kingdom

Trial participating centre

East Suffolk and North Essex NHS Foundation Trust
Colchester District General Ho Turner Road
Colchester
CO4 5JL
United Kingdom

Trial participating centre

Tameside and Glossop Integrated Care NHS Foundation Trust
Tameside General Hospital Fountain Street
Ashton-Under-Lyne
OL6 9RW
United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Foundation Trust
The Resource Trust HQ Duncan Macmillan House Porchester Road
Nottingham
NG3 6AA
United Kingdom

Trial participating centre

Avon and Wiltshire Mental Health Partnership NHS Trust
Jenner House Avon Way Langley Park
Chippenham
SN15 1GG
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Trust Headquarters Queens Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Surrey and Borders Partnership NHS Foundation Trust
18 Mole Business Park Randalls Road
Leatherhead
KT22 7AD
United Kingdom

Trial participating centre

Birmingham and Solihull Mental Health NHS Foundation Trust
Unit 1 50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom

Trial participating centre

James Paget University Hospitals NHS Foundation Trust
Lowestoft Road Gorleston Great Yarmouth
Norfolk
NR31 6LA
United Kingdom

Trial participating centre

The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
Queen Elizabeth Hospital Gayton Road
Kings Lynn
PE30 4ET
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane Colney
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Derbyshire Healthcare NHS Foundation Trust
Trust Headquarters Kingsway Hospital Kingsway
Derby
DE22 3LZ
United Kingdom

Trial participating centre

The Royal Orthopaedic Hospital NHS Foundation Trust
The Woodlands Bristol Road South Northfield
Birmingham
B31 2AP
United Kingdom

Trial participating centre

Hertfordshire Partnership University NHS Foundation Trust
99 Waverley Road
St. Albans
AL3 5TL
United Kingdom

Trial participating centre

Bedford Hospital NHS Trust
South Wing Kempston Road
Bedford
MK42 9DJ
United Kingdom

Trial participating centre

Royal Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

Lincolnshire Partnership NHS Foundation Trust
Units 8 & 9 The Point Lions Way
Sleaford
NG34 8GG
United Kingdom

Trial participating centre

Leicestershire Partnership NHS Trust
Riverside House Bridge Park Plaza Bridge Park Road Thurmaston
Leicester
LE4 8PQ
United Kingdom

Trial participating centre

Cambridgeshire Community Services NHS Trust
Unit 3 Meadow Lane
St. Ives
PE27 4LG
United Kingdom

Trial participating centre

East of England Ambulance Service NHS Trust
Ambulance Station Hospital Lane Hellesdon
Norwich
NR6 5NA
United Kingdom

Trial participating centre

Bridgewater Community Healthcare NHS Foundation Trust
Bevan House 17 Beecham Court
Wigan
WN3 6PR
United Kingdom

Trial participating centre

Torbay and South Devon NHS Foundation Trust
Hengrave House Torbay Hospital Newton Road
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

Cornwall Partnership NHS Foundation Trust
Porthpean Road
St Austell
PL26 6AD
United Kingdom

Trial participating centre

Pennine Acute Hospitals NHS Trust
Trust Headquarters North Manchester General Hospital Delaunays Road Crumpsall
Manchester
M8 5RB
United Kingdom

Trial participating centre

North East London NHS Foundation Trust
West Wing C E M E Centre Marsh Way
Rainham
RM13 8GQ
United Kingdom

Trial participating centre

Southern Health NHS Foundation Trust
Maples Buildings Tatchbury Mount Hospital Calmore
Southampton
SO40 2RZ
United Kingdom

Trial participating centre

Essex Partnership University NHS Foundation Trust
The Lodge Runwell Chase Runwell
Wickford
SS11 7XX
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Salford Royal Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Midlands Partnership NHS Foundation Trust
Trust Headquarters St. Georges Hospital Corporation Street
Stafford
ST16 3SR
United Kingdom

Trial participating centre

Pennine Care NHS Foundation Trust
225 Old Street Ashton-Under-Lyne
Lancashire
OL6 7SR
United Kingdom

Trial participating centre

Norfolk Community Health and Care NHS Trust
Norwich Community Hospital Bowthorpe Road
Norwich
NR2 3TU
United Kingdom

Trial participating centre

Coventry and Warwickshire Partnership NHS Trust
Wayside House Wilsons Lane
Coventry
CV6 6NY
United Kingdom

Trial participating centre

Calderdale and Huddersfield NHS Foundation Trust
Royal Infirmary Acre Street
Huddersfield
HD3 3EA
United Kingdom

Trial participating centre

Wye Valley NHS Trust
County Hospital Union Walk
Hereford
HR1 2ER
United Kingdom

Trial participating centre

Greater Manchester Mental Health NHS Foundation Trust
Prestwich Hospital Bury New Road Prestwich
Manchester
M25 3BL
United Kingdom

Trial participating centre

Devon Partnership NHS Trust
Wonford House Hospital Dryden Road
Exeter
EX2 5AF
United Kingdom

Trial participating centre

North West Ambulance Service NHS Trust
Ladybridge Hall 399 Chorley New Road
Bolton
BL1 5DD
United Kingdom

Trial participating centre

Solent NHS Trust
Solent NHS Trust Headquarters Highpoint Venue Bursledon Road
Southampton
SO19 8BR
United Kingdom

Trial participating centre

Isle of Wight NHS Trust
St Mary's Hospital Parkhurst Road
Newport
PO30 5TG
United Kingdom

Trial participating centre

Central London Community Healthcare NHS Trust
Ground Floor 15 Marylebone Road
London
NW1 5JD
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Shrewsbury and Telford Hospital NHS Trust
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

Walsall Healthcare NHS Trust
Manor Hospital Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Black Country Partnership NHS Foundation Trust
Delta Point Greets Green Road
West Bromwich
B70 9PL
United Kingdom

Trial participating centre

The Royal Wolverhampton NHS Trust
New Cross Hospital Wolverhampton Road Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
De La Court House Queen Alexandra Hospital Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Assessment and Treatment Centre Chapel Street
Chichester
PO19 1BX
United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

The Christie NHS Foundation Trust
550 Wilmslow Road Withington
Manchester
M20 4BX
United Kingdom

Trial participating centre

University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-On-Trent
ST4 6QG
United Kingdom

Trial participating centre

North West Anglia NHS Foundation Trust
Edith Cavell Hospital Bretton Gate Bretton
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
Warneford Hospital Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

Tees, Esk and Wear Valleys NHS Foundation Trust
Trust Headquarters West Park Hospital Edward Pease Way
Darlington
DL2 2TS
United Kingdom

Trial participating centre

South Central Ambulance Service NHS Foundation Trust
7-8 Talisman Road
Bicester
OX26 6HR
United Kingdom

Trial participating centre

East and North Hertfordshire NHS Trust
Lister Hospital Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

South West London and St George's Mental Health NHS Trust
Springfield Hospital 61 Glenburnie Road
London
SW17 7DJ
United Kingdom

Trial participating centre

Yeovil District Hospital NHS Foundation Trust
Yeovil District Hospital Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Trial participating centre

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Gobowen
Oswestry
SY10 7AG
United Kingdom

Trial participating centre

South Warwickshire NHS Foundation Trust
Warwick Hospital Lakin Road
Warwick
CV34 5BW
United Kingdom

Trial participating centre

The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Trial participating centre

Southern Health NHS Foundation Trust
Maples Buildings Tatchbury Mount Hospital Calmore
Southampton
SO40 2RZ
United Kingdom

Trial participating centre

The Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
York Hospital Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

West Suffolk NHS Foundation Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Trial participating centre

The Dudley Group NHS Foundation Trust
C Block Russells Hall Hospital Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

Gloucestershire Care Services NHS Trust
Edward Jenner Court 1010 Pioneer Avenue Gloucester Business Pk Brockworth
Gloucester
GL3 4AW
United Kingdom

Trial participating centre

East Cheshire NHS Trust
Macclesfield District Gen Hospital Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

North Cumbria University Hospitals NHS Trust
West Cumberland Hospital Hensingham
Whitehaven
CA28 8JG
United Kingdom

Trial participating centre

Northern Devon Healthcare NHS Trust
North Devon District Hospital Raleigh Park
Barnstaple
EX31 4JB
United Kingdom

Trial participating centre

Lincolnshire Community Health Services NHS Trust
Beech House Witham Park Waterside South
Lincoln
LN5 7JH
United Kingdom

Trial participating centre

Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom

Trial participating centre

Whittington Health NHS Trust
The Whittington Hospital Magdala Avenue
London
N19 5NF
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

East London NHS Foundation Trust
9 Alie Street Aldgate
London
E1 8DE
United Kingdom

Trial participating centre

Birmingham Community Healthcare NHS Foundation Trust
3, Priestley Wharf Holt Street Birmingham Science Park Aston
Birmingham
B7 4BN
United Kingdom

Trial participating centre

South Western Ambulance Service NHS Foundation Trust
Westcountry House Abbey Court, Eagle Way Sowton Industrial Estate
Exeter
EX2 7HY
United Kingdom

Trial participating centre

Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton Hospital Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

George Eliot Hospital NHS Trust
Lewes House College Street
Nuneaton
CV10 7DJ
United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Trial participating centre

Dorset County Hospital NHS Foundation Trust
Dorset County Hospital Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

St George's University Hospitals NHS Foundation Trust
St George's Hospital Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Trust Offices Guy's Hospital Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Croydon Health Services NHS Trust
Croydon University Hospital London Road
Thornton Heath
CR7 7YE
United Kingdom

Trial participating centre

NIHR CRN: North East and North Cumbria
NE3 3HD
United Kingdom

Trial participating centre

NIHR CRN: North West Coast
L7 8XP
United Kingdom

Trial participating centre

NIHR CRN: Yorkshire and Humber
S10 2SB
United Kingdom

Trial participating centre

NIHR CRN: Greater Manchester
M13 9WL
United Kingdom

Trial participating centre

NIHR CRN: East Midlands
LE1 5WW
United Kingdom

Trial participating centre

NIHR CRN: West Midlands
CV3 2TX
United Kingdom

Trial participating centre

NIHR CRN: West of England
BS1 2NT
United Kingdom

Trial participating centre

NIHR CRN: Thames Valley and South Midlands
OX3 9DU
United Kingdom

Trial participating centre

NIHR CRN: Eastern
NR1 1QQ
United Kingdom

Trial participating centre

NIHR CRN: Kent, Surrey and Sussex
ME8 0NZ
United Kingdom

Trial participating centre

NIHR CRN: Wessex
SO30 2UN
United Kingdom

Trial participating centre

NIHR CRN: South West Peninsula
PL6 8BX
United Kingdom

Trial participating centre

NIHR CRN: North Thames
W1T 7HA
United Kingdom

Trial participating centre

NIHR CRN: South London
SE1 9RT
United Kingdom

Trial participating centre

NIHR CRN: North West London
W12 0HT
United Kingdom

Sponsor information

Organisation

Cambridgeshire and Peterborough NHS Foundation Trust

Sponsor details

Elizabeth House
Fulbourn Hospital
Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom
+44 (0)1223217418
R&D@cpft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Medical Research Council; Grant Codes: MC_PC_17213

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website
5. Other publication
6. Submission to regulatory authorities
7. Access to raw data and right to publish freely by all investigators in study or by Independent Steering Committee
on behalf of all investigators

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository:
1. University of Cambridge Research Data Repository, https://www.data.cam.ac.uk/repository
2. Available from publication
3. Indefinitely
4. Public, unrestricted
5. Consent obtained from all participants for publication of anonymised data
6. Re anonymisation:
6.1. All e-mail addresses (given optionally for receipt of results) removed prior to final data set creation and analysis
6.2. All free-text data removed from raw data
6.3. Ages pre-blurred to ranges
6.4. All geographic indicators blurred to UK Lower Layer Super Output Area (LSOA) codes (England and Wales), Data Zones (Scotland), and Super Output Areas (Northern Ireland)

Intention to publish date

31/12/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/01/2020: Uploaded protocol Version 4, 19 December 2019 (not peer reviewed). 13/01/2020: Trial's existence confirmed by the NIHR.