Summaries of the trial:

LoTS care Newsletters:


This trial has been approved by the Leeds (West) Research Ethics Committee.
Reference number: 08/H1307/43

International Standard Randomised Controlled Trial Number (ISRCTN): 67932305

This study has been adopted by the UK Stroke Research Network (UKSRN).

This trial is being sponsored by the Bradford Teaching Hospitals NHS Foundation Trust.

This trial is funded as part of a National Institute for Health Research (NIHR) Programme Grant for Applied Research and by The Stroke Association

This trial is being conducted in collaboration with the Clinical Trials Research Unit (CTRU).

the stroke association the stroke association

 

System of Care Trial

The LoTS care Stroke System of Care Trial is a cluster randomised controlled trial of a patient and carer-centred system of longer-term stroke care.

Aims

This study aims to evaluate the clinical and cost effectiveness of our new system for longer-term stroke care which has been developed by a comprehensive review of the evidence and forms a patient centred structured assessment.

Stroke care co-ordinators have been trained to deliver the system of care. The trial aims to recruit 800 patients (with and without carers) in 32 stroke care co-ordinator led services around the UK.

Objectives

The LoTS care trial aims to evaluate whether our new system of care improves psychological and functional outcomes of patients and carers living at home in the community when compared to usual practice.

Primary Objective: To determine whether the system of care improves psychological outcomes for patients requiring longer-term support at home

Secondary Objectives:

  1. To determine whether the provision of the system of care improves functional outcomes for patients requiring longer-term support at home
  2. To determine whether the provision of the system of care improves psychological and functional outcomes for carers of patients requiring longer-term support at home
  3. To assess whether the system of care is cost-effective based on patient outcomes from both health/social care and societal perspectives.

A concurrent realist evaluation on the trial is being led by Natasha Alvarado as part of a fellowship award from the Stroke Association.

Recent Status

Phase 1 of patient recruitment started in July 2009 and phase 2 of patient recruitment started in February 2010. Intervention services have received two training days and are implementing the system of care into their practice. Control services are carrying on as normal.

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Recruitment of the target 800 patients
was achieved on 31st March 2011

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recruitment graph

401 patients were recruited to the intervention arm and 399 to the control arm. 26% of patients also have carers who have been recruited to the trial.

6 month and 12 month follow up of participants is complete and analysis is ongoing.

 

trial timeline

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