Analysis 1.30. Comparison 1 Rehabilitation versus control, Outcome 30 TUG Test (by gender).. .. .. .. Analysis 1.31. Comparison 1 Rehabilitation versus control, Outcome 31 Walking speed (by risk of bias).. .. . Analysis 1.32. Comparison 1 Rehabilitation versus control, Outcome 32 Walking speed (by duration of intervention). Analysis 1.33. Comparison 1 Rehabilitation versus control, Outcome 33 Walking speed (by mode of delivery).. . Analysis 1.34. Comparison 1 Rehabilitation versus control, Outcome 34 Walking speed (by baseline walking speed). Analysis 1.35. Comparison 1 Rehabilitation versus control, Outcome 35 Walking speed (by age).. .. .. .. Analysis 1.36. Comparison 1 Rehabilitation versus control, Outcome 36 Walking speed (by gender).. .. .. . Analysis 1.37. Comparison 1 Rehabilitation versus control, Outcome 37 Walking speed (by distance walked).. .. Analysis 1.38. Comparison 1 Rehabilitation versus control, Outcome 38 Death (by risk of bias).. .. .. .. Analysis 1.39. Comparison 1 Rehabilitation versus control, Outcome 39 Death (by duration of intervention).. .. Analysis 1.40. Comparison 1 Rehabilitation versus control, Outcome 40 Death (by mode of delivery).. .. .. Analysis 1.41. Comparison 1 Rehabilitation versus control, Outcome 41 Death (by age
physical rehabilitation may improve independence for elderly long-term care facility residents, but mean effects are small. It is unclear which interventions are most appropriate.
Several brief cognitive tests have shown promising diagnostic test accuracy results for identifying aMCI. However, concerns over the quality of the constituent studies and lack of evidence on the predictive validity of these tests mean that new validation studies are warranted. Copyright © 2016 John Wiley & Sons, Ltd.
IntroductionThis study investigated the validity of two brief cognitive tests (Memory Alteration Test [M@T] and Test Your Memory [TYM] test) for identifying people with aMCI in the community.MethodsOlder people were invited to participate by their general practitioner practice. Eligible participants were assessed for aMCI using an operationalized approach to the Petersen criteria and the M@T and TYM.ResultsBoth tests demonstrated significant ability in discriminating between people with aMCI and controls (AUC = 0.91 for M@T and 0.80 for TYM [P < .001 for both]). M@T performed with higher sensitivity than TYM (85% vs. 63%) and similar specificity (84% vs. 87%). Both tests demonstrated moderate test-retest reliability (κ = ∼0.5) and took <10 minutes to administer.DiscussionM@T and TYM are quick to administer. M@T demonstrated higher diagnostic test accuracy than TYM and could provide an efficient method for identifying aMCI in clinical and research settings.
BackgroundWhilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors’ quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings.Methods/designThis mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial.DiscussionThis process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care.Trial registrationISRCTN Registry, ISRCTN38920246. Registered on 22 June 2016.
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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2669-5) contains supplementary material, which is available to authorized users.
Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.
Background: Sedentary behaviour has been the focus of considerable clinical, policy and research interest due to its detrimental effects on health and wellbeing. This systematic review aims to (1) develop a more precise description of different categories of interventions that aim to reduce sedentary time in adults by identifying specific components that form an intervention; (2) explore the effect of different categories of interventions in reducing time spent sedentary in adults. Methods: Ten electronic databases, websites of relevant organisations (e.g. the Sedentary Behaviour Research Network), and relevant reviews were searched. Inclusion criteria: Randomised controlled trials (RCTs), including cluster and randomised cross-over trials, in the adult population (clinical and non-clinical). Any study including a measure of sedentary behaviour was included even if reducing sedentary behaviour was not the primary aim. Exclusion criteria: Interventions delivered in schools, colleges, or workplaces; studies investigating the immediate effects of breaking up sitting time as part of a supervised (usually laboratory-based) intervention. Two review authors conducted data extraction and quality assessment (GRADE approach). Results: Searches identified 39,223 records, of which 85 studies met the inclusion criteria and were included in the review. Interventions shown to significantly reduce time spent sedentary were those which incorporated the provision of information, education, or support (advice/recommendations), in conjunction with either counselling (mean difference: -52.24 minutes/day; 95% CI: -85.37 to -19.10) or a form of structured/prescribed physical activity (standardised mean difference: -0.15; 95% CI: -0.23 to -0.07). However, this positive effect was not maintained at follow-up. No interventions were shown to break up prolonged sitting. Conclusions: This review presents a novel way of categorising interventions according to the types of components they comprised. There is evidence that interventions might be effective in reducing time spent sedentary immediately post-intervention. There were limited studies measuring sustained behaviour change.
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