Remote STrOke Rehabilitation (ReSTORe): a UK-wide randomised controlled trial

This Data Sharing Agreement (DSA) concerns the necessary processing of personal data for NHS England’s provision of an NHS DigiTrials Recruitment Service on behalf of the University Hospitals Coventry and Warwickshire NHS Trust, and the University of Warwick for the purpose of ‘Remote STrOke Rehabilitation (ReSTORe): a UK-wide randomised controlled trial.’

The ReSTORe study aims to find out if a home-based, supervised online programme can help improve well-being after a stroke. The ReSTORe study will be looking at which of these two treatments will help people recover the most:

1. A single online session of advice and support with a trained professional.

OR

2. A 10-week supervised, online, home-based, group exercise and recovery support programme.

The ReSTORe study aims to recruit 600 participants overall and by the time use of the NHS DigiTrials recruitment service starts will likely have approximately 400 participants remaining to recruit, meeting the following inclusion criteria:

• UK resident (of which NHS DigiTrials will identify English residents only)

• Aged ≥18.

• 6 to 36 months post-hospital discharge after admission for stroke.

• Discharged to home address

NHS England will identify potential (English) participants meeting the eligibility criteria specified by University of Warwick and University Hospitals of Coventry and Warwickshire NHS Trust and facilitate contact via letter, to provide information about the ReSTORe study and provide details of how people can give consent to participate if they wish.

The number of individuals who will be sent communications will be proportionately limited based on the estimated response rate. If the target number of participants is not achieved, the number of individuals who are sent communications may be increased in increments. Based off current estimates, 30,000 invitations will be issued to achieve the target of 600 participants.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the Demographics dataset to the third party mailing provider via NHS Notify. The Data will contain directly identifying data items including Names, Address, Postcode which are required for the purpose of contacting potential participants.

The Data will not be transferred to any other location.

University of Warwick and UHCW will not be given access to any individual’s data unless they are contacted directly by the individual following the mailout.

The Data will be stored on servers at an approved third party provider.

The Data will be accessed onsite at the premises of the 3rd party mailing provider only.

The Data will not be linked with any other data.

The approved third party provider will destroy all data files received from NHS England 2 weeks post mail-out, as instructed by NHS England.

Each time NHS England create and disseminate an extract, the records will be added to a mailing list cohort dataset. Should a fresh extract be produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations. This mailing list dataset will be maintained for six months after the invitation process is complete in case this is required for analysis purposes by the data controller. Only aggregated data would be used for such analysis.

Individuals who wish to participate following receipt of the invitation letter will directly contact the trial team via an online portal to register their interest.

The aims of the Recruitment Service are to efficiently target large pools of potential participants for recruitment leading to higher conversation rates and faster trial enrolment.

Any benefits to health and/or social care would be achieved by the clinical trial which is enabled by the use of the NHS DigiTrials Recruitment Service.

The NHS DigiTrials Recruitment Service aims to optimise recruitment utilising large message quantities to recruit in a timely, effective and efficient manner.

Yielded Benefits is not a requirement for new applications.