An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Abstract

Background: Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation.

Methods/design: A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation.

Discussion: This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention.

Trial registration: ISRCTN38920246 . Registered 22 June 2016.

Keywords: Cluster trial; Community; Complex intervention; Facilitated self-management; Feasibility trial; Longer term; Stroke; Study within a trial (SWAT).

Fig. 1

SPIRIT figure. *Interventions delivered at site level for duration of trial until at least 2 months after participant recruitment approach has ended. ^$Further detail is provided in Table 1. ^% Timepoints are post-randomisation

Fig. 2

a Participant identification flow diagram. b Baseline consent and questionnaire completion flow diagram

Fig. 3

Follow-up flow diagram. *Prior to posting the follow-up pack the CTRU will confirm the stroke survivors’ and carers’ survival status and current address. Subject to consent and collection of phone number from the stroke survivor/consultee/carer; CTRU will send reminders to the stroke survivor/consultee/carer via Short Message Service (SMS) text message as a prompt to complete the questionnaires