Dataset Information

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

ABSTRACT:

Background

To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementing a future definitive cluster randomised controlled trial of the developed intervention (New Start) to support stroke survivors and their carers in the longer term.

Methods

A feasibility cluster randomised controlled trial was conducted in English and Welsh NHS stroke services. Stroke services (clusters) were randomised on a 1:1 basis to implement New Start or continue with usual care only. Community-dwelling stroke survivors between 4 and 6 months post-stroke were invited to participate in the trial by post. Outcome measures were collected via post at 3, 6 and 9 months after recruitment. Recruitment and follow-up rates, delivery and uptake of the intervention, data collection feasibility (including postal outcome measures of health and disability, mental well-being at 3, 6, and 9 months post-recruitment) and safety were assessed.

Results

Ten stroke services were recruited. A total of 1127 stroke survivors were screened for participation, and 269 were registered (New Start, n = 145; usual care, n = 124). Retention was high with 239 (89%) stroke survivors being available for follow-up at 9 months, and high return rates of postal questionnaires were achieved (80.3% at 9 months). Intervention training was successfully delivered, and New Start was offered to 95.2% of trial participants in the intervention arm. Uptake was variable, however, ranging from 11.8 to 75.0%. There were no safety concerns.

Conclusions

Stroke service recruitment and longer-term stroke survivor postal recruitment and outcome data collection are feasible; however, refinement of intervention targeting and delivery is required prior to undertaking a definitive trial.

Trial registration

ISRCTN38920246. Registered 22 June 2016 ( http://www.isrctn.com/ISRCTN38920246 ).

SUBMITTER: Forster A

PROVIDER: S-EPMC10015731 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

Forster Anne A Ozer Seline S Brindle Richard R Barnard Lorna L Hardicre Natasha N Crocker Thomas F TF Chenery Marie M Moreau Lauren L Wright Alan A Burton Louisa-Jane LJ Hartley Suzanne S Hulme Claire C Dawkins Bryony B Holloway Ivana I House Allan A Hewison Jenny J Farrin Amanda A

Pilot and feasibility studies 20230315 1

<h4>Background</h4>To address the limited provision of longer-term stroke care, we conducted a programme of research (LoTS2Care) to develop and test an intervention to form part of a replicable longer-term care strategy. New Start, a programme of facilitated self-management, was developed to be delivered at 6 months post-stroke by trained facilitators. Here, we report the findings from the final workstream of this programme, which aimed to evaluate the feasibility and acceptability of implementi ...[more]

PMID: 36922866

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Project description:BackgroundDespite 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/designA 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.DiscussionThis 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 registrationISRCTN38920246 . Registered 22 June 2016.

Project description:ObjectiveInvestigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.DesignPragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.SettingClusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.ParticipantsAdult carers in participating clusters were referred to the study by cluster staff following initial support contact.InterventionsIntervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable).Outcome measuresParticipants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff.Primary outcome3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ).Secondary outcomesFACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L.Randomisation and maskingClusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only.ResultsBetween 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced.Primary outcome measureintention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of -0.04 (95% CI -0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention.ConclusionsThe intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers' research and service development, staff training and organisational support would need to be enhanced.Trial registration numberISRCTN58414120.

Project description:BackgroundStroke often results in chronic disability, with partners and family members taking on the role of informal caregiver. There is considerable uncertainty regarding how best to identify and address carers' needs. The Carer Support Needs Assessment Tool (CSNAT) is a carer-led approach to individualised assessment and support for caregiving that may be beneficial in palliative care contexts. CSNAT includes an implementation toolkit. Through collaboration, including with service users, we adapted CSNAT for stroke and for use in a UK stroke specialist organisation providing long-term support. The main aims of OSCARSS are to investigate the clinical and cost-effectiveness of CSNAT-Stroke relative to current practice. This paper focuses on the trial protocol, with the embedded process evaluation reported separately.MethodsLongitudinal, multi-site, pragmatic, cluster randomised controlled trial with a health economic analysis. Clusters are UK services randomised to CSNAT-Stroke intervention or usual care, stratified by size of service. Eligible carer participants are: adults aged > 18 years; able to communicate in English; referred to participating clusters; and seen face-to-face at least once by the provider, for support. The 'date seen' for initial support denotes the start of intervention (or control) and carers are referred to the research team after this for study recruitment. Primary outcome is caregiver strain (FACQ - Strain) at three months after 'date seen'. Secondary outcomes include: caregiver distress; positive caregiving appraisals (both FACQ subscales); Pound Carer Satisfaction with Services; mood (HADs); and health (EQ-5D5L) at three months. All outcomes are followed up at six months. Health economic analyses will use additional data on caregiver health service utilisation and informal care provision.DiscussionOSCARSS is open to recruitment at the time of article submission. Study findings will allow us to evaluate the clinical and cost-effectiveness of the CSNAT-Stroke intervention, directed at improving outcomes for informal carers of stroke survivors. Trial findings will be interpreted in the context of our embedded process evaluation including qualitative interviews with those who received and provided services as well as data on treatment fidelity. OSCARSS will contribute to knowledge of the unmet needs of informal stroke caregivers and inform future stroke service development.Trial registrationISRCTN Registry, ISRCTN58414120 . Registered on 26 July 2016.

Project description:IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.

Project description:BackgroundCare transitions from hospital to home are a critical period for patients and their families, especially after a stroke. The aim of this study was to assess the feasibility, fidelity and acceptability of a co-designed care transition support for stroke survivors.MethodsA non-randomised controlled feasibility study recruiting patients who had had stroke and who were to be discharged home and referred to a neurorehabilitation team in primary healthcare was conducted. Data on the feasibility of recruitment and fidelity of the intervention were collected continuously during the study with screening lists and checklists. Data on the perceived quality of care transition were collected at 1-week post-discharge with the Care Transition Measure. Data on participant characteristics, disease-related data and outcomes were collected at baseline (hospitalisation), 1 week and 3 months post-discharge. Data on the acceptability of the intervention from the perspective of healthcare professionals were collected at 3 months using the Normalisation Measure Development Questionnaire.ResultsAltogether, 49 stroke survivors were included in the study: 28 in the intervention group and 21 in the control group. The recruitment and data collection of patient characteristics, disease-related data, functioning and outcomes were feasible. The fidelity of the intervention differed in relation to the different components of the co-designed care transition support. The intervention was acceptable from the perspective of healthcare professionals. Concerns were raised about the fidelity of the intervention. A positive direction of effects of the intervention on the perceived quality of the care transition was found.ConclusionThe study design, data collection, procedures and intervention were deemed feasible and acceptable. Modifications are needed to improve intervention fidelity by supporting healthcare professionals to apply the intervention. The feasibility study showed a positive direction of effect on perceived quality with the care transition, but a large-scale trial is needed to determine its effectiveness.Patient or public contributionStroke survivors, significant others and healthcare professionals were involved in a co-design process, including the joint development of the intervention's components, contextual factors to consider, participant needs and important outcomes to target.Trial registrationClinicalTrials.gov ID: NCT0292587.

Project description:BackgroundFamily carers play a crucial role in supporting the health and well-being of people with intellectual disabilities. Given their role and responsibilities, many family carers experience significant and ongoing stress and mental health difficulties. Programmes and interventions which provide training and support to family carers have been shown to have a positive impact on levels of stress and quality of life. However, these are often face to face which can create barriers to full participation. Online interventions have been shown to offer flexibility in delivery compared with traditional face-to-face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is improved mental health in family carers of people with intellectual disabilities.MethodsFamily carers (n = 120) will be randomised to receive the intervention (n = 60) or assigned to a wait-list control (n = 60) group. The intervention ( www.Carers-ID.com ) consists of 14 modules which cover topics including the following: promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports and managing family conflict and information for siblings who are carers. The intervention has been co-produced with voluntary sector organisations and family carers and tested for acceptability. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and 3 months after completion). These include the following: the Depression, Anxiety and Stress Scale, the Warwick-Edinburgh Mental Well-being Scale, the Resilience Scale and the Social Connectedness Scale Revised. Participants (n = 12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation.DiscussionThe Carers-ID intervention provides an online resource for family carers to support their mental health and well-being and promote their resilience. It represents an affordable and accessible means of delivering such support. Testing the feasibility of the intervention and related trial procedures is required to determine whether a full-scale randomised controlled trial to evaluate the intervention's effectiveness is warranted.Trial registrationClinicalTrials.gov : NCT05737823.

Project description:BackgroundElectronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke.MethodsA phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1-2 years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2-3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability.ResultsOf 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16 months after stroke): 25 to intervention (median age 69 years; 40% female) and 29 to control (median age 68 years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ≥ 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: β coefficient 0.34; 95% CI - 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group.ConclusionThese findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke.Trial registrationANZCTR, ACTRN12618001519246 . Registered on 11 September 2018-retrospectively registered.

Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.

Project description:BackgroundLess than 50% of stroke survivors regain their pre-stroke level of upper limb function, compounded with a lack of long-term rehabilitation options available. The Graded Repetitive Arm Supplementary Programme (GRASP) is an evidence-based upper limb programme delivered as a standalone programme to stroke survivors. To improve access to such a programme, there is the potential to combine it with a high-utility community-based exercise programme, such as the post-rehabilitation enablement programme (PREP). We aimed to establish if this was feasible to deliver alongside the experience of stroke survivors and therapists, identify any refinements the intervention and the acceptability of the intervention and trial procedures.MethodsA cluster feasibility-controlled trial was conducted using both quantitative and qualitative outcome measures with stroke survivors who were discharged from NHS care. Participants completed PREP for 6 weeks (control), with the intervention group also completing GRASP. The GRASP intervention was refined in between five iterative testing cycles. Focus groups with participants explored the acceptability and feasibility. Individual interviews with intervention therapists explored how feasible it was to embed the intervention into practice, and determine the feasibility of a future larger, mixed methods, randomised controlled trial. Clinical endpoints for upper limb and overall function were explored through the Rating of Everyday Arm use in the Community and Home, 10-metre walk test (10MWT) and quality of life via the Shortened Edinburgh Warwick questionnaire. No further suggestions for intervention design were noted after cycle 4.ResultsRecruitment (n=72) and retention levels (84.7%) were high with 61 participants (mean age of 66 years and 49 weeks post-stroke) completing the study. Participants and therapists reported positive acceptability of the intervention with goal setting and family support noted as beneficial. The home exercise programme was noted as challenging. Participants within both groups demonstrated improvements in clinical measures, with the intervention group demonstrating a greater improvement within the Rating of Everyday Arm-use in the Community and Home and the 10MWT.ConclusionThis study successfully recruited and retained stroke survivors into an upper limb community-based programme. It poses a feasible delivery mechanism to combine evidence-based upper limb approaches with established physical activity programmes in a future large scale and fully powered study.Trial registration numberNCT05090163.

Dataset Information

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

Background

Methods

Results

Conclusions

Trial registration

Publications

An intervention to support stroke survivors and their carers in the longer term: results of a cluster randomised controlled feasibility trial (LoTS2Care).

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