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Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.

ABSTRACT: INTRODUCTION:Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke. METHODS AND ANALYSIS:The proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods. ETHICS AND DISSEMINATION:The study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences. TRIAL REGISTRATION NUMBER:NCT03730701.

SUBMITTER: Patomella AH

PROVIDER: S-EPMC6830652 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.

Patomella Ann-Helen AH Guidetti Susanne S Mälstam Emelie E Eriksson Christina C Bergström Aileen A Åkesson Elisabet E Kottorp Anders A Asaba Eric E

BMJ open 20191102 11

<h4>Introduction</h4>Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce m ...[more]

PMID: 31678952

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Project description:BackgroundThe consequences of lifestyle-related disease represent a major burden for the individual as well as for society at large. Individual preventive health checks to the general population have been suggested as a mean to reduce the burden of lifestyle-related diseases, though with mixed evidence on effectiveness. Several systematic reviews, on the other hand, suggest that health checks targeting people at high risk of chronic lifestyle-related diseases may be more effective. The evidence is however very limited. To effectively target people at high risk of lifestyle-related disease, there is a substantial need to advance and implement evidence-based health strategies and interventions that facilitate the identification and management of people at high risk. This paper reports on a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care designed to systematically identify persons at risk of developing lifestyle-related disease or who engage in health-risk behavior, and provide targeted and coherent preventive services to these individuals.MethodsThe intervention took place over a three-month period from September 2016 to December 2016. Taking a two-pronged approach, the design included both a joint and a targeted intervention. The former was directed at the entire population, while the latter specifically focused on patients at high risk of a lifestyle-related disease and/or who engage in health-risk behavior. The intervention was facilitated by a digital support system. The evaluation of the pilot will comprise both quantitative and qualitative research methods. All outcome measures are based on validated instruments and aim to provide results pertaining to intervention acceptability, feasibility, and short-term effects.DiscussionThis pilot study will provide a solid empirical base from which to plan and implement a full-scale randomized study with the central aim of determining the efficacy of a preventive health intervention.Trial registrationRegistered at Clinical Trial Gov (Unique Protocol ID: TOFpilot2016 ). Registered 29 April 2016. The study adheres to the SPIRIT guidelines.

Project description:BACKGROUND:Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies on the prevention of striae gravidarum and large, robust trials are lacking. Until such time as more products are investigated, much of the knowledge remains anecdotal. This pilot study will evaluate the feasibility of conducting a study to evaluate the effectiveness of a commercially available moisturising oil compared to no treatment for the prevention and reduction in severity of striae gravidarum. METHODS:The definitive study will be a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. This protocol is for a pilot randomised trial to evaluate the feasibility of conducting such a study. The pilot study will be a two-arm, unblinded, pragmatic parallel randomised trial with a 1:1 randomisation ratio between control and intervention groups. Women in the intervention group will be asked to apply a moisturising oil to their abdomen during pregnancy, while women in the control group will not use any treatment. It is proposed to recruit 20 primigravida, who are 12-16 weeks pregnant from an Irish Maternity Hospital, in each arm to assess the feasibility of running such a trial. DISCUSSION:This pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN76992326 . Registered on 14 July 2017.

Project description:BackgroundCardiovascular disease (CVD) is the leading cause of death globally. Community pharmacist intervention studies have demonstrated clinical effectiveness for improving several leading individual CVD risk factors. Primary prevention strategies increasingly emphasise the need for consideration of overall cardiovascular risk and concurrent management of multiple risk factors. It is therefore important to demonstrate the feasibility of multiple risk factor management by community pharmacists to ensure continued currency of their role.Methods/designThis study will be a longitudinal pre- and post-test pilot study with a single cohort of up to 100 patients in ten pharmacies. Patients aged 50-74 years with no history of heart disease or diabetes, and taking antihypertensive or lipid-lowering medicines, will be approached for participation. Assessment of cardiovascular risk, medicines use and health behaviours will be undertaken by a research assistant at baseline and following the intervention (6 months). Validated interview scales will be used where available. Baseline data will be used by accredited medicines management pharmacists to generate a report for the treating community pharmacist. This report will highlight individual patients' overall CVD risk and individual risk factors, as well as identifying modifiable health behaviours for risk improvement and suggesting treatment and behavioural goals. The treating community pharmacist will use this information to finalise and implement a treatment plan in conjunction with the patient and their doctor. Community pharmacists will facilitate patient improvements in lifestyle, medicines adherence, and medicines management over the course of five counselling sessions with monthly intervals. The primary outcome will be the change to average overall cardiovascular risk, assessed using the Framingham risk equation.DiscussionThis study will assess the feasibility of implementing holistic primary CVD prevention programs into community pharmacy, one of the most accessible health services in most developed countries.Trial registrationAustralia and New Zealand Clinical Trial Registry Number: ACTRN12609000677202.

Project description:INTRODUCTION:The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS:A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9?months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION:National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER:NCT02429180; Pre-results.

Project description:IntroductionStroke is a major health problem and transient ischaemic attack (TIA) is an important risk factor for stroke. Primary prevention of stroke and TIA will have the greatest impact on reducing the burden of these conditions. Evidence-based guidelines for stroke/TIA prevention identify individuals eligible for preventative interventions in primary care. This study will investigate: (1) the proportion of strokes/TIAs with prior missed opportunities for prevention in primary care; (2) the influence of patient characteristics on missed prevention opportunities and (3) how the proportion of missed prevention opportunities has changed over time.Methods and analysisA retrospective case review will identify first-ever stroke and patients with TIA between 2000 and 2013 using anonymised electronic medical records extracted from the health improvement network (THIN) database. Four categories of missed opportunities for stroke/TIA prevention will be sought: untreated high blood pressure in patients eligible for treatment (either blood pressure ?160/100 or ?140/90 mm Hg in patients at high cardiovascular disease (CVD) risk); patients with atrial fibrillation with high stroke risk and no anticoagulant therapy; no lipid modifying drug therapy prescribed in patients at high CVD risk or with familial hypercholesterolaemia. The proportion of patients with each missed opportunity and multiple missed opportunities will be calculated. Mixed effect logistic regression will model the relationship between demographic and patient characteristics and missed opportunities for care; practice will be included as a random effect.Ethics and disseminationTHIN data collection was approved by the NHS South East Multi-centre Research Ethics Committee (MREC) in 2003. This study was approved by the independent scientific review committee in May 2013. Dissemination of findings has the potential to change practice, improve the quality of care provided to patients and ultimately reduce the incidence of strokes and TIAs. Findings will be published in a peer-reviewed journal and disseminated at national and international conferences.

Project description:IntroductionPrimary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.Methods and analysisMixed methods will be used: (1) design: intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.Trial registration numberNCT03353519; Pre-results.

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Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.

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Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.

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