A longer-term care strategy for stroke – a feasibility study
Research type
Research Study
Full title
A longer-term care strategy to support stroke survivors and their carers (LoTS2Care) – A feasibility study
IRAS ID
188147
Contact name
Jane Dennison
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN38920246
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
The LoTS2Care intervention ‘Moving Forward’ is designed to improve QoL by addressing unmet needs and enhancing participation in Stroke Survivors. We wish to undertake a feasibility cluster randomised controlled trial (cRCT) to inform the design and implementation of a large-scale, definitive cRCT of the Moving Forward intervention plus usual care (UC) vs. UC only. \n\nTen stroke services will be randomised on a 1:1 basis tol deliver the Moving Forward intervention plus UC, or UC only. It is anticipated that 200 Stroke Survivors will be recruited from these stroke services. We will also recruit their carers if available. Cluster randomisation has been chosen to reduce between-group contamination as the Moving Forward intervention aims to impact on staff skills, knowledge and practice. All Stroke Survivors within the stroke service will have the opportunity to receive the allocated intervention. \n\nStroke Survivors approximately six months post-stroke will be identified by colleagues in the stroke service and approached for consent and data collection. Consenting Stroke Survivors will be registered and outcome assessments undertaken at baseline and three, six and nine months post-registration. Data will be collected on training, implementation and delivery of the Moving Forward intervention in sites so randomised. Data on treatment received in both arms will also be collected to document UC. All outcome measures will be collected from both trial arms and we will explore the use of routine data sources to capture some outcome data as appropriate. \n\nAn embedded health economics study will develop an economic model. The aim of the model will be to assess the long term cost-effectiveness of the intervention, an integrated care strategy, compared to UC and to undertake a value of information analysis in order to inform the design of any subsequent cRCT. We will also incorporate a within-trial analysis of cost-effectiveness using the feasibility data.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0068
Date of REC Opinion
26 Apr 2016
REC opinion
Further Information Favourable Opinion