STRIDES: Strategies to improve donor experiences
| ISRCTN | ISRCTN10412338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10412338 |
- Submission date
- 24/10/2019
- Registration date
- 24/10/2019
- Last edited
- 14/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
Strangeways Research Lab
Worts Causeway
Cambridge
CB1 8RN
United Kingdom
| Phone | +44 (0)1223748659 |
|---|---|
| ed303@medschl.cam.ac.uk |
Scientific
Strangeways Research Lab
Worts Causeway
Cambridge
CB18RN
United Kingdom
| Phone | +44 (0)1223747228 |
|---|---|
| am2663@medschl.cam.ac.uk |
Study information
| Study design | Cluster randomized crossover/stepped-wedge factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | http://www.strides-study.org.uk/about/pis/ |
| Scientific title | Strategies to Improve Donor Experiences |
| Study acronym | STRIDES |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 23/04/2018 |
| Completion date | 11/03/2029 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,300,000 |
| Total final enrolment | 1381520 |
| Key inclusion criteria | All donors attending the donation sites involved in the study |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 04/11/2019 |
| Date of final enrolment | 04/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Head Office
500 North Bristol Park
Filton
Bristol
BS34 7QH
United Kingdom
Sponsor information
Hospital/treatment centre
NHS Blood and Transplant
c/o Research Office
500 North Bristol Park
Filton
Bristol
BS34 7QH
England
United Kingdom
| Phone | +44 (0)117 921 7501 |
|---|---|
| research.office@nhsbt.nhs.uk | |
"ROR" |
https://ror.org/0227qpa16 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- National Health Service Blood and Transplant, UK National Health Service Blood and Transplant, NHSBT
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| 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 peer reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | version 3 | 01/11/2022 | 22/12/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 10/08/2023 | 14/08/2023 | Yes | No |
Additional files
Editorial Notes
14/05/2024: The intention to publish date was changed from 30/11/2023 to 30/11/2024.
14/08/2023: Publication reference added.
22/12/2022: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The total final enrolment was added.
3. The intention to publish date was changed from 11/03/2030 to 30/11/2023.
15/10/2020: The recruitment resumed.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
24/10/2019: Trial’s existence confirmed by East of England - Cambridge South Research Ethics Committee
