Promoting group identity to improve questionnaire return rates in a multicentre randomised controlled trial
| ISRCTN | ISRCTN16675252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16675252 |
| IRAS number | 293630 |
| Secondary identifying numbers | SWAT 51, IRAS 293630, HTA - NIHR130454 |
- Submission date
- 21/10/2021
- Registration date
- 03/11/2021
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
When participants stay involved in a clinical trial after their treatment has finished, it allows researchers to collect important follow-up information about the study treatments. Unfortunately, participants often drop out of the study before the end, and the reasons for this are poorly understood. High levels of patient dropout is a particular problem in clinical trials that involve patients in critical care. This may be because participants are recruited when they are unconscious and lack capacity. Participants may not understand how important it is to collect information about people’s health several months after they are discharged from ICU.
Researchers want to see if they can improve the collection of follow-up information in the MARCH trial by running a small study at the same time, called a Study Within a Trial (or SWAT). SWATs help researchers find out the best way to run studies. The researchers want to know whether communication aimed at making people feel part of the MARCH study improves the return rate of follow-up questionnaires. After their discharge from hospital, the researchers will send some study participants a thank you card, personalised letters, and a promotional item (e.g. reusable coffee cup) to encourage the feeling of being part of a group. They will then work out if people feel they belong to the study group, and whether belonging to the study group increases the number of patients who complete and return two health-related questionnaires which will be sent 6 months after they first joined the study.
Who can participate?
In order to take part in the SWAT, patients enrolled in the main MARCH trial must have:
1. Regained consciousness and be able to make decisions for themselves
2. Given consent to continue participation in the main trial
3. Been discharged from hospital
What does the study involve?
Participants will be assigned to one of three groups, called ‘S1’, ‘S2’ and ‘S3’, at random (or by chance). This ensures that the groups are compared fairly. The S3 group will receive the letters that would normally be used to contact patients in a clinical trial. This group is known as the control group. Patients in the other two groups (S1 and S2) will both receive a thank you card and specially adapted letters. The S2 group will also receive a promotional item. Participants will not be aware that they are taking part in the SWAT.
What are the possible benefits and risks of participating?
This SWAT will provide useful information for researchers to improve patient communication to increase the return of follow-up questionnaires for clinical studies in the future. The researchers do not anticipate any risks associated with being part of this study.
Where is the study run from?
Northern Ireland Clinical Trials Unit (NICTU) (UK)
When is the study starting and how long is it expected to run for?
May 2021 to July 2025
Who is funding the study?
National Institute for Health Research and Care Research Health Technology Assessment (NIHR HTA) Programme (HTA - NIHR130454) (UK)
Who is the main contact?
Dr Ashley Agus
Ashley.Agus@nictu.hscni.net
Contact information
Public
Northern Ireland Clinical Trials Unit (NICTU)
7 Lennoxvale
Belfast
BT9 5BY
United Kingdom
| Phone | +44 (0)28961 51447 |
|---|---|
| MARCH@nictu.hscni.net |
Scientific
Northern Ireland Clinical Trials Unit (NICTU)
7 Lennoxvale
Belfast
BT9 5BY
United Kingdom
 ORCID ID |
0000-0001-9839-6282 |
|---|---|
| Phone | +44 (0)28961 51447 |
| Ashley.Agus@nictu.hscni.net |
Study information
| Study design | Multicentre parallel randomized controlled trial embedded within a randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A theory-based intervention for promoting group identity to improve questionnaire return rates in the MARCH multicentre randomised controlled trial: a Study Within a Trial (SWAT) |
| Study acronym | MARCH: SWAT |
| Study hypothesis | A Self-Categorisation Theory-based intervention to actively promote group identity in trial participants will improve 6-month questionnaire return rates. |
| Ethics approval(s) | Approved 15/10/2021, Yorkshire & The Humber - Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8105, +44 (0)207 104 8103, +44 (0)207 104 8018; leedseast.rec@hra.nhs.uk), REC ref: 21/YH/0234 |
| Condition | Trial follow up/retention |
| Intervention | Participants will be randomised (1:1:1, using mixed block sizes) to one of three arms comprising two SWAT group identity intervention arms (S1 and S2) and one control arm (S3). The randomisation process will be separate from the main trial randomisation. The MARCH trial statistician will generate the randomisation sequence using NQuery Advisor. S1 and S2 will receive the same correspondence (thank you card, letter and questionnaire incorporating theory-informed wording and adapted trial logo), but S2 will also receive a promotional item (e.g. reusable coffee cup or water bottle). Patients allocated to the SWAT control arm (S3) will receive the standard trial follow-up correspondence (letter and questionnaire incorporating standard trial follow-up wording and standard trial logo, no thank you card). The wording of the SWAT correspondence has been designed in consultation with the MARCH Patient and Family Advisory Group, consisting of former critical care patients and family members. |
| Intervention type | Other |
| Primary outcome measure | The return rate for questionnaires sent to participants at 6 months. The researchers will compare the combination of S1 and S2 versus S3 to assess the impact of increasing the salience of the MARCH trial as a “group” on the return rate. They will also compare S1 versus S2 to assess the additional impact of sending a promotional item on the return rate. |
| Secondary outcome measures | 1. Group identification at 6 months post-randomisation, measured using the single-item social identification instrument and a study-specific group membership Likert scale question. The researchers will compare the combination of S1 and S2 versus S3 to assess the impact of increasing the salience of the MARCH trial as a “group” on group identification. They will also compare S1 versus S2 to assess the additional impact of sending a promotional item on group identification 2. Total costs associated with embedding the SWAT in the MARCH trial; a spreadsheet of the trial resources and related costs (e.g. trial team time input, consumables) associated with the SWAT will be maintained prospectively over the study period by the trial team to allow total costs to be calculated at the end of the study (51-month study duration) 3. Cost per additional questionnaire returned; this will be calculated as the incremental cost of embedding the SWAT divided by the incremental number of questionnaires returned at the end of the study (51-month study duration) |
| Overall study start date | 01/05/2021 |
| Overall study end date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 1172 |
| Total final enrolment | 1956 |
| Participant inclusion criteria | 1. MARCH trial participants who have regained capacity 2. Given consent to continue participation in the main trial 3. Who have been discharged from hospital |
| Participant exclusion criteria | Does not meet the inclusion criteria |
| Recruitment start date | 17/02/2022 |
| Recruitment end date | 30/04/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Liverpool
L7 8XP
United Kingdom
Derry/Londonderry
BT47 6SB
United Kingdom
Ballymena
BT43 6DA
United Kingdom
Barnsley
S75 2EP
United Kingdom
Birmingham
B15 2GW
United Kingdom
Bristol
BS1 3NU
United Kingdom
Edinburgh
EH1 3EG
United Kingdom
Newcastle upon Tyne
NE7 7DN
United Kingdom
Glasgow
G12 0XH
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
London
SE1 7EH
United Kingdom
Hull
HU3 2JZ
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
London
SE5 9RS
United Kingdom
Leicester
LE1 5WW
United Kingdom
Gillingham
ME7 5NY
United Kingdom
West Glamorgan
SA12 7BR
United Kingdom
Taunton
TA1 5DA
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Poole
BH15 2JB
United Kingdom
London
SE13 6LH
United Kingdom
Rotherham
S60 2UD
United Kingdom
Reading
RG1 5AN
United Kingdom
Poole
BH15 2JB
United Kingdom
Truro
TR1 3LJ
United Kingdom
Liverpool
L7 8XP
United Kingdom
Manchester
M8 5RB
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Bath
BA1 3NG
United Kingdom
Belfast
BT12 6BA
United Kingdom
Manchester
M6 8HD
United Kingdom
Bristol
BS10 5NB
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Watford
WD18 0HB
United Kingdom
Manchester
M13 9WL
United Kingdom
York
YO31 8HE
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Colchester
CO4 5JL
United Kingdom
Preston
PR2 9HT
United Kingdom
Clydebank
G81 4DY
United Kingdom
Coventry
CV2 2DX
United Kingdom
Gwent
NP18 3XQ
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Manchester
M23 9LT
United Kingdom
Manchester
M8 5RB
United Kingdom
Belfast
BT9 7AB
United Kingdom
West Bromwich
B71 4HJ
United Kingdom
London
SE18 4QH
United Kingdom
London
SE1 9RT
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Bordesley Green
Birmingham
B9 5SS
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Warrington
WA5 1QG
United Kingdom
London
NW3 2QG
United Kingdom
Torquay
TQ2 7AA
United Kingdom
London
NW1 2PG
United Kingdom
Bedford
MK42 9DJ
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Sheffield
S10 2JF
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
Bury St Edmund
IP33 2QZ
United Kingdom
Airdrie
ML6 0JS
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Willesborough
Ashford
TN24 0LZ
United Kingdom
Derriford
Plymouth
PL6 8DH
United Kingdom
Glasgow
G51 4TF
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Barnstaple
EX31 4JB
United Kingdom
Winchester
SO22 5DG
United Kingdom
Sponsor information
Hospital/treatment centre
Research Office
2nd Floor King Edward Building
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Phone | +44 (0)28 961 56057 |
|---|---|
| Alison.Murphy@belfasttrust.hscni.net | |
| Website | http://www.belfasttrust.hscni.net/ |
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact open access peer-reviewed journal. The MARCH protocol will be published in a peer-reviewed scientific journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study (MARCH: SWAT) will be available upon request following the publication of the primary and secondary outcomes. Formal requests for data should be made in writing to Prof. Danny McAuley (Chief Investigator) or Dr Bronwen Connolly (Co-Chief Investigator) via the Northern Ireland Clinical Trials Unit (NICTU) and will be reviewed on a case by case basis in collaboration with the Sponsor. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/04/2025: The recruitment end date was changed from 28/02/2025 to 30/04/2025.
26/11/2024: The following changes were made:
1. The recruitment end date was changed from 31/10/2024 to 28/02/2025.
2. East Surrey Hospital, Peterborough City Hospital, The Royal Marsden Hospital, Birmingham City Hospital, Stoke Mandeville Hospital, Royal Papworth Hospital, Royal Surrey County Hospital, and Nottingham City Hospital study participating centres were removed.
3. Warrington Hospital, Royal Free Hospital, Torbay Hospital, University College London Hospital, Bedford Hospital, Aberdeen Royal Infirmary, Glan Clwyd Hospital, Wrexham Maelor Hospital, Royal Hallamshire Hospital, Northern General Hospital, West Suffolk Hospital, University Hospital Monklands, Yeovil District Hospital, William Harvey Hospital, Derriford Hospital, Queen Elizabeth University Hospital, Lincoln County Hospital, Royal Devon & Exeter Hospital, North Devon District Hospital, and Royal Hampshire County Hospital study participating centres were added.
4. The intention to publish date was changed from 31/07/2026 to 30/11/2026.
5. A study contact was changed.
01/08/2024: Total final enrolment number added.
03/11/2023: The study website was updated.
11/04/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/02/2022 to 17/02/2022.
2. Addenbrookes Hospital, Heartlands Hospital, Chesterfield Royal Hospital, John Radcliffe Hospital and Victoria Hospital have been added to the trial participating centres.
09/11/2021: The recruitment start date was changed from 01/11/2021 to 01/02/2022.
27/10/2021: Trial's existence confirmed by the NIHR.
