Plain English Summary
Background and study aims
The STRIDES study aims to reduce adverse events related to blood donation by implementing variations on the current interventions. Reducing adverse events is likely to increase donor retention and therefore the number of blood units donated for NHS patients. The study will include changes to the material read prior to donation, the drink consumed prior to donation and the advice given during and after the donation experience. All blood donors in England who attend a blood donation session during the study period will anonymously participate, with the option to opt-out. The results from this study will help inform national policies that should optimise blood collection procedures, minimise donor reactions, improve donor return rates, and improve donor (and staff) well-being and satisfaction. In addition to the main study, up to 250,000 donors will be asked if they wish to join the STRIDES BioResource, part of the NIHR BioResource. The STRIDES BioResource aims to provide additional biological (blood samples) and questionnaire data to address the overall aims of the STRIDES study
Who can participate?
Adults who attend an NHS blood donation clinic in England during the study period
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future blood donors. The study’s results should yield evidence-based policies to reduce adverse events for NHSBT and other blood services; lead to improvements in donor health, experience, and service efficiency (e.g., better retention of donors, who may be more likely to give blood repeatedly). There are no additional risks to participating in the usual blood donation
Where is the study run from?
The STRIDES study is being run by the University of Cambridge and takes place in all NHSBT blood donation clinics across England
When is the study starting and how long is it expected to run for?
November 2019 until November 2029
Who is funding the study?
NHS Blood and Transplant team (NHSBT) (UK)
Who is the main contact?
1. Prof Emanuele Di Angelantonio
ed303@medschl.cam.ac.uk
2. Prof John Danesh
jd292@medschl.cam.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Emanuele Di Angelantonio
ORCID ID
Contact details
Strangeways Research Lab
Worts Causeway
Cambridge
CB1 8RN
United Kingdom
+44 (0)1223748659
ed303@medschl.cam.ac.uk
Type
Scientific
Additional contact
Dr Amy McMahon
ORCID ID
Contact details
Strangeways Research Lab
Worts Causeway
Cambridge
CB18RN
United Kingdom
+44 (0)1223747228
am2663@medschl.cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
v3.0
Study information
Scientific title
Strategies to Improve Donor Experiences
Acronym
STRIDES
Study hypothesis
A single intervention or combination of interventions will improve donor experiences by reducing adverse events in and out of the blood donation session
Ethics approval
Approved 21/11/2018, East of England - Cambridge South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8134; NRESCommittee.EastofEngland-CambridgeSouth@nhs.net), ref: 18/EE/0284
Study design
Cluster randomized crossover/stepped-wedge factorial trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Other
Patient information sheet
http://www.strides-study.org.uk/about/pis/
Condition
Blood donor health
Intervention
We will compare four different interventions with current NHSBT practice:
1. Isotonic hydration before donation: 500ml isotonic drink vs. current 500ml plain water
2. Time on donation chair after donation: 3-minutes before standing vs. current 2-minutes
3. Modified applied muscle tension (AMT) exercises: new AMT vs. current practice of AMT
4. Psychosocial intervention: preparatory materials vs. current practice of nothing
The study design is tailored to the specific needs of our study and NHSBT: a cluster-randomised cross-over/stepped-wedge factorial trial involving the whole of NHSBT for 36 months. A minimisation algorithm was used to ensure that, when clusters are randomised to each intervention, balance is maintained in important stratifying factors
Depending on the intervention assigned:
1. In addition to the NHSBT welcome leaflet donors will be given a copy of the 2-sided STRIDES psychosocial leaflet, which will provide guidance of what to expect during and after donation, what to do while donating blood and advice
2. Instead of a 500ml glass of water/squash, donors will be asked to drink a 500ml low-sugar isotonic drink. A poster will be provided about the drink and the contents of the drink will be displayed
3. If donors are eligible to give blood, they will receive modified instructions for Applied Muscle Tension by way of a 1-page study-specific leaflet
4. If a donor is eligible to give blood, a donor’s time in the donation chair following blood donation will be increased from 2 to 3 minutes.
In addition, on arrival of a donor at the donation session, a member of the donation team will ask donors whether they would wish to consider participation in the BioResource. If the donor agrees they will be consented and additional blood samples will be taken from the satellite pouch during the donation. Once home, the donor will receive an email like to complete a health and lifestyle questionnaire to help address the main aims of the study. Anonymous data will be provided to the University of Cambridge by NHSBT
Intervention type
Other
Phase
Drug names
Primary outcome measure
Number of in-session vasovagal reactions (VVRs) with loss of consciousness (i.e. episodes involving loss of consciousness of any duration, with or without additional complications) observed by NHSBT staff
Secondary outcome measures
1. All in-session VVRs (i.e. with and without loss of consciousness)
2. All delayed VVRs (i.e. VVRs with and without loss of consciousness after leaving the donation venue)
3. Delayed VVRs with loss of consciousness; and
4. Any in-session non-VVR adverse events or reactions
Overall trial start date
23/04/2018
Overall trial end date
11/03/2029
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All donors attending the donation sites involved in the study
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
1,300,000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
04/11/2019
Recruitment end date
04/11/2022
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NHS Blood and Transplant
NHS Blood and Transplant
Head Office
500 North Bristol Park
Filton
Bristol
BS34 7QH
United Kingdom
Sponsor information
Organisation
NHS Blood and Transplant
Sponsor details
NHS Blood and Transplant
c/o Research Office
500 North Bristol Park
Filton
Bristol
BS34 7QH
United Kingdom
+44 (0)117 921 7501
research.office@nhsbt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
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
Funder name
NIHR Blood and Transplant Research Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR BioResource
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Anonymous participant level data will be available upon request and approval by the Data Access Committee for the study. Applications can be requested by contacting donorhealth@medschl.cam.ac.uk, 01223 747226. Only relevant information/variables will be provided and the whole data set is unlikely to be released.
Intention to publish date
11/03/2030
Participant level data
Available on request
Basic results (scientific)
Publication list