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

Forster, Anne; Hartley, Suzanne; Barnard, Lorna; Ozer, Seline; Hardicre, Natasha; Crocker, Thomas F; Fletcher, Marie; Moreau, Lauren; Atkinson, Ross; Hulme, Claire; Holloway, Ivana; Schmitt, Laëtitia; House, Allan; Hewison, Jenny; Richardson, Gillian; Farrin, Amanda

doi:10.1186/s13063-018-2669-5

Cited by 12 publications

(13 citation statements)

References 31 publications

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“…The worksheet provided a framework of responses informed by the socio-ecological model [32]. Other evidence included: Behavioural and environmental factors included in the logic model of the prioritised problemFacilitators that were identified in components two and three and previous similar work focused on developing longer-term support stroke survivors and their carers (LoTS2Care) [35]Theories of information seeking [36, 37] identified through rapid scoping of the literature.…”

Section: Methodsmentioning

confidence: 99%

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Supporting carers of stroke survivors to reduce carer burden: development of the Preparing is Caring intervention using Intervention Mapping

et al. 2019

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BackgroundBurden is well documented among carers of stroke survivors, yet current evidence is insufficient to determine if any strategies reduce this negative outcome. Existing interventions for carers of stroke survivors typically involve supporting carers according to their individual needs through face-to-face interactions and provision of information including workbooks or educational guides. To date, no interventions have been developed using a method which systematically incorporates evidence, behaviour change theories, and stakeholder involvement to change the behaviours of carers and relevant individuals who support carers. This study aimed to develop a programme plan for a theory and evidence-based intervention to reduce burden in carers of stroke survivors.MethodsInformed by evidence from two systematic reviews and 33 qualitative interviews, the first four stages of Intervention Mapping were used to guide the intervention development process: 1) needs assessment; 2) identifying outcomes and objectives; 3) selecting theoretical methods and practical applications; and 4) creating a programme plan. Structured and facilitated involvement from stakeholders, including carers, researchers, and professionals from health and community services was integral to the intervention development process. Stakeholders helped to prioritise the focus of the intervention, develop the goals, outcomes and objectives for the programme, and generate and refine intervention ideas.ResultsStakeholders prioritised the need for carers to feel prepared before and during the transition from hospital to home as key to reducing burden. The proposed intervention ‘Preparing is Caring’ targets this need and involves providing and signposting carers to relevant information and support for practical and emotional needs. This is to be delivered before, during, and immediately after the stroke survivor’s transition from hospital to home by a person taking on a single point of contact role. It is comprised of multiple theory-based components including: training packages for information and support providers working with carers and wider staff teams, plus elements to support carers to feel prepared.ConclusionsWe have developed a comprehensive programme plan for a multiple-component, theory and evidence informed behaviour change intervention aimed at preparing carers before and during the transition from hospital to home. Future work is required to refine, implement and evaluate the Preparing is Caring intervention.

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Section: Methodsmentioning

confidence: 99%

“…Facilitators that were identified in components two and three and previous similar work focused on developing longer-term support stroke survivors and their carers (LoTS2Care) [35]…”

Section: Methodsmentioning

confidence: 99%

Supporting carers of stroke survivors to reduce carer burden: development of the Preparing is Caring intervention using Intervention Mapping

et al. 2019

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“…5,7 The LoTS2Care feasibility trial protocol was previously published and includes a brief description of the SWAT design. 3…”

Section: Study Within a Trial Designmentioning

confidence: 99%

“…2 LoTS2Care, a feasibility cluster Randomised Controlled Trial (cRCT), part of an National Institute for Health Research programme grant for applied research, recruited 269 stroke survivors across 10 stroke services, along with 85 carers, at approximately 6 months post-stroke. 3,4 Participants were followed-up at 3 months, 6 months and 9 months post-registration date using postal questionnaires to collect self-reported outcomes.…”

Section: Introductionmentioning

confidence: 99%

Is two better than one? Maximising follow-up of self-reported outcome measures for a stroke survivor population: Results from a study within a trial in the LoTS2Care feasibility study

Moreau

Holloway

Ozer

et al. 2022

Research Methods in Medicine & Health Sciences

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Background: Improving outcome data collection rates is an essential part of managing clinical trials and ensures statistical power and generalisability of results are maintained. Studies within a trial (SWATs) provide a robust methodology to investigate the most efficient methods to maximise outcome follow-up. Methods: LoTS2Care, a feasibility cluster Randomised Controlled Trial, recruited 269 stroke survivors across 10 services, and incorporated a SWAT to evaluate the effect of questionnaire booklet format (one booklet or two) on follow-up rates for self-reported postal outcomes at 6 and 9 months post-recruitment. Available participants were individually randomised (1 : 1) by the Clinical Trials Research Unit and follow-up rates in the two groups were compared. Results: At 6 months post-recruitment, 254 participants were randomised: 126 to receive (125 posted) the single booklet; 128 to receive two booklets. By 9 months post-recruitment, 116 and 123 participants were still available in each group, respectively. For participants randomised to two booklets, return of at least one of the booklets was considered as ‘followed-up’. At 6 months, 114/125 (91.2%) participants sent the single booklet returned it, compared to 108/128 (84.4%) sent two (odds ratio (OR) 1.92, 95% confidence interval (CI) 0.88 to 4.19). By 9 months, 108/116 (93.1%) participants returned the single booklet, compared to 105/123 (85.4%) sent two (OR 2.31, 95% CI 0.97 to 5.55). Conclusions: The SWAT was an inexpensive, straightforward way to test how booklet format affected follow-up rates. Larger participant numbers would be required for conclusive results. These initial findings, however, suggest that including all outcome measures in a single booklet may maximise return rates, especially in trials with similar populations, such as those living with brain injury, cognitive or speech impairment or older people.

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“…Efforts to develop an evidence-based pathway for longer-term care in stroke have increased in recent years [7][8][9][10]. One promising approach to improve longer-term outcomes is 'selfmanagement'.…”

Section: Introductionmentioning

confidence: 99%

Development of a self-management intervention for stroke survivors with aphasia using co-production and behaviour change theory: An outline of methods and processes

et al. 2021

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Background Self-management is a promising approach to improve quality of life after stroke. However, evidence for the appropriateness and effectiveness of self-management for stroke survivors with aphasia is limited. This article reports on the process used to develop a supported self-management intervention for stroke survivors with aphasia (SSWA) using co-production and behaviour change theory. Preparatory research included systematic reviews, and qualitative interviews and focus groups with SSWA, family members and speech and language therapists (SLTs). Materials and methods We conducted six, 2 hour long intervention development workshops with key stakeholders. The workshops were informed by principles of co-production and the intervention development process outlined by the Behaviour Change Wheel (BCW). We also incorporated the findings of our preparatory research within workshops. Each workshop included an introduction, 1–2 co-production tasks and time for feedback at the end of the session. Data were analysed on an ongoing basis so that findings could be used to feed in to subsequent workshops and intervention development. Results Workshop participants (n = 12) included; SSWA (n = 5), family members (n = 3) and SLTs (n = 4). Together, participants engaged with accessible and participatory co-production tasks which aligned with the BCW framework. Participants engaged in discussion to define self-management in behavioural terms (behavioural diagnosis) and to identify what needed to change to support self-management. Participant’s co-produced solutions for supporting self-management and discussed options to implement these in practice. Prototype materials were generated by the research team and evaluated by participants. Intervention functions and behaviour change techniques (BCTs) were mapped to the solutions generated by participants by the research team, after the final workshop. A supported self-management intervention for SSWA was developed which will be delivered by SLTs through community stroke services. Conclusions This paper reports the process we used to integrate co-production work with behaviour change theory to develop a complex self-management intervention. This is of relevance for researchers looking to harness the strengths of co-production methods and theory in intervention design. Future research will feasibility test the supported self-management intervention developed. This paper provides transparency to our intervention development process which will help others to better interpret the findings of our feasibility work.

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

Cited by 12 publications

References 31 publications

Supporting carers of stroke survivors to reduce carer burden: development of the Preparing is Caring intervention using Intervention Mapping

Supporting carers of stroke survivors to reduce carer burden: development of the Preparing is Caring intervention using Intervention Mapping

Is two better than one? Maximising follow-up of self-reported outcome measures for a stroke survivor population: Results from a study within a trial in the LoTS2Care feasibility study

Development of a self-management intervention for stroke survivors with aphasia using co-production and behaviour change theory: An outline of methods and processes

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