Submission date
01/08/2023
Registration date
07/08/2023
Last edited
01/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Not Applicable
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims 
The demand for organ donations in the UK exceeds the supply, despite changes in the law to an opt-out system in 2020. Previous research indicates that factors like age, gender, ethnicity, education, and attitude influence donation behaviour. The Muslim community, in particular, exhibits lower rates of organ donation, but interventions addressing religious permissibility have shown promise.
This study aims to investigate the impact of comic and written narrative interventions on organ donation registration decisions and willingness to share these decisions among individuals from the Islamic faith. Additionally, the researchers will assess the effectiveness of these interventions in improving knowledge of organ donation.

Who can participate? 
Adults (aged 18 years and above) from the Islamic faith, residing in Scotland, Wales, England, or Northern Ireland, who can read English. Participation will be through the online Prolific platform.

What does the study involve? 
Participants will be randomly assigned to three groups receiving different organ-donation narratives: existing NHS Blood and Transplant (NHSBT) website information only, NHSBT information with a comic-style narrative, or NHSBT information with a written narrative. The researchers will collect data at three timepoints: baseline, immediately after reading the narrative and 1 month later during the follow-up.

What are the possible benefits and risks of participating?
The goal is to achieve an increase in organ donation registrations among the Muslim population. The study poses minimal risks, as it does not involve biological samples, treatments, or sensitive questions.

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

When is the study starting and how long is it expected to run for?
January 2023 to July 2024

Who is funding the study?
National Health Service Blood and Transplant (NSHBT), Department of Health and Social Care (UK)

Who is the main contact?
Simonne Weeks , S.Weeks@brighton.ac.uk 

Study website

Contact information

Type

Principal Investigator

Contact name

Mrs Simonne Weeks

ORCID ID

http://orcid.org/0000-0002-0390-9119

Contact details

University of Brighton
Cockcroft Building
Lewes Road
Brighton
BN2 4NU
United Kingdom
+44 (0)1273 600900
s.weeks@brighton.ac.uk

Additional identifiers

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Secondary identifying numbers

Nil known

Study information

Scientific title

Effect of reading comics vs written narrative on organ donation registration rates amongst Muslim adult population in the UK: a randomised control trial

Acronym

Study hypothesis

This research will investigate whether the development and evaluation of comic and written narrative interventions to increase engagement in registering and discussing an organ donation choice which is a NHSBT commitment to build support for donation amongst Black, Asian, mixed heritage and minority ethnic communities. Specifically, this research will evaluate amongst Muslims whether:

H1: Comics and/or written narratives will increase the number of organ donation choice registrations in comparison to control groups.
H2: Comics and/or written narratives will increase the sharing, discussing and promoting their organ donation choice with others one-month post-intervention.

Ethics approval(s)

Approved 25/07/2023, Cross School Research Ethics Committee (University of Brighton, Mithras House, Lewes Road, Brighton, BN2 4AT, United Kingdom; +44 (0)1273 600900; l.wignall@brighton.ac.uk), ref: CREC 12487

Study design

Randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Internet/virtual

Study type

Efficacy

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Registrations on the UK NHSBT Organ Donation Register

Intervention

To establish the effectiveness of comics and test whether comic style adds anything to the outcomes, participants will be randomised into a 1:1:1 allocation ratio. The control will be pre-existing NHSBT information related to the comic and written narrative content located on the NHSBT website.

All eligible participants will be randomly assigned into three different study arms:
1. Read NHSBT website information only (control)
2. NHSBT information and COMICS narrative (comic intervention)
3. NHSBT information and WRITTEN narrative (written intervention)

Using a web-based randomisation algorithm, Qualtrics will randomly allocate participants to each of the experimental arms with 1:1:1 allocation. Because Prolific handles the interaction between the study investigators and participants, the participants will be completely anonymous to the study investigators. The outcome measures will be self-reported and submitted anonymously. Participants and members of the research team will be blinded to the trial arm allocation.

Intervention type

Behavioural

Primary outcome measure

Registration rates depending on the narrative format measured using self-reported donor status at 1-month follow-up survey post intervention

Secondary outcome measures

1. Attitudes towards narrative format measured using the Attitude Information Score in the immediate post-intervention survey
2. Likelihood to use narrative measured using the Discuss Information Scale in the immediate post-intervention survey
3. Discussion rates depending on the narrative format using self-reported Discuss Donation Status at 1-month follow-up survey post intervention
4. Attitudes towards organ donation measured using the Affective Attitude Score at 1-month follow-up survey post intervention

Overall study start date

01/01/2023

Overall study end date

01/07/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Resident of the UK
2. Aged 18 years or older
2. Identifies as part of the Islamic religion
3. Reads English
4. Agrees to 1-month follow up

Participant type(s)

Healthy volunteer

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

293

Participant exclusion criteria

1. Prolific approval rating of less than 95%
2. Have at least 20 previous prolific submissions

Recruitment start date

14/08/2023

Recruitment end date

01/11/2023

Locations

Countries of recruitment

England, Northern Ireland, Scotland, United Kingdom, Wales

Study participating centre

University of Brighton
Mithras House
Lewes Road
Brighton
Sussex
BN2 4AT
United Kingdom

Sponsor information

Organisation

University of Brighton

Sponsor details

Mithras House
Lewes Road
Brighton
BN2 4AT
England
United Kingdom
+44 (0)1273 600900
l.wignall@brighton.ac.uk

Sponsor type

University/education

Website

http://www.brighton.ac.uk/

ROR

https://ror.org/04kp2b655

Funders

Funder type

Government

Funder name

NHS Blood and Transplant

Alternative name(s)

National Health Service Blood and Transplant, UK National Health Service Blood and Transplant, NHSBT

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will publish the research findings in peer-reviewed journals and present them at scientific conferences. Open-access publishing will be prioritised for wider accessibility. Lay summaries will be created to communicate with the public. Collaboration with stakeholders and data sharing will be pursued. The primary outcomes will be published promptly after the study's completion. This plan aims to promote transparency and contribute valuable knowledge to the scientific community and the public.

Intention to publish date

14/08/2024

Individual participant data (IPD) Intention to share

No

IPD sharing plan

The data-sharing plans for the current study are unknown and will be made available at a later date.

IPD sharing plan summary

Data sharing statement to be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes

01/08/2023: Study's existence confirmed by the Cross School Research Ethics Committee.