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 in...
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2018-06-01
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Series: | Trials |
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Online Access: | http://link.springer.com/article/10.1186/s13063-018-2669-5 |
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Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anne Forster Suzanne Hartley Lorna Barnard Seline Ozer Natasha Hardicre Tom Crocker Marie Fletcher Lauren Moreau Ross Atkinson Claire Hulme Ivana Holloway Laetitia Schmitt Allan House Jenny Hewison Gillian Richardson Amanda Farrin on behalf of the LoTS2Care Programme Management Group |
spellingShingle |
Anne Forster Suzanne Hartley Lorna Barnard Seline Ozer Natasha Hardicre Tom Crocker Marie Fletcher Lauren Moreau Ross Atkinson Claire Hulme Ivana Holloway Laetitia Schmitt Allan House Jenny Hewison Gillian Richardson Amanda Farrin on behalf of the LoTS2Care Programme Management Group An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial Trials Stroke Longer term Feasibility trial Community Study within a trial (SWAT) Facilitated self-management |
author_facet |
Anne Forster Suzanne Hartley Lorna Barnard Seline Ozer Natasha Hardicre Tom Crocker Marie Fletcher Lauren Moreau Ross Atkinson Claire Hulme Ivana Holloway Laetitia Schmitt Allan House Jenny Hewison Gillian Richardson Amanda Farrin on behalf of the LoTS2Care Programme Management Group |
author_sort |
Anne Forster |
title |
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial |
title_short |
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial |
title_full |
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial |
title_fullStr |
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial |
title_full_unstemmed |
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial |
title_sort |
intervention to support stroke survivors and their carers in the longer term (lots2care): study protocol for a cluster randomised controlled feasibility trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-06-01 |
description |
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. |
topic |
Stroke Longer term Feasibility trial Community Study within a trial (SWAT) Facilitated self-management |
url |
http://link.springer.com/article/10.1186/s13063-018-2669-5 |
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doaj-9b8e90befbe44ee28de7aa312294fba52020-11-25T01:11:58ZengBMCTrials1745-62152018-06-0119111410.1186/s13063-018-2669-5An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trialAnne Forster0Suzanne Hartley1Lorna Barnard2Seline Ozer3Natasha Hardicre4Tom Crocker5Marie Fletcher6Lauren Moreau7Ross Atkinson8Claire Hulme9Ivana Holloway10Laetitia Schmitt11Allan House12Jenny Hewison13Gillian Richardson14Amanda Farrin15on behalf of the LoTS2Care Programme Management GroupAcademic Unit of Elderly Care and Rehabilitation, Leeds Institute of Health Sciences, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsAcademic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation TrustAcademic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation TrustAcademic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation TrustClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsAcademic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation TrustAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of LeedsLeeds Institute of Health Sciences, University of LeedsCentre for Health Services Research, Leeds Institute of Health Sciences, University of LeedsLeeds Institute of Cardiovascular and Metabolic Medicine, University of LeedsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of LeedsAbstract 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.http://link.springer.com/article/10.1186/s13063-018-2669-5StrokeLonger termFeasibility trialCommunityStudy within a trial (SWAT)Facilitated self-management |