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Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors.

ABSTRACT: Recovery after stroke is long-term and demanding. Optimising community-residing stroke survivors' capability to self-manage their health is integral. Recent systematic reviews have shown that stroke self-management programmes were associated with significant improvement in stroke survivors' health-related quality of life and self-efficacy. However some programmes were not designed with an underpinning theoretical framework. The aim of this study is to compare the effectiveness of a nurse-led stroke self-management programme with usual care on recovery of community-residing stroke survivors.A single-blinded, two-arm, randomised controlled trial will be conducted. Patients with a history of first or recurrent ischaemic or haemorrhagic stroke who will be discharged to home settings will be recruited from acute stroke units of three acute public hospitals in Hong Kong. The estimated sample size is 160 (80 participants per group). Eligible participants will be randomised to receive either usual care or a 4-week nurse-led community-based self-management programme plus usual care after discharge. The programme, underpinned by Bandura's constructs of self-efficacy and outcome expectation, includes one individual home visit, two community-based group sessions, and three follow-up phone calls. Primary outcomes include stroke survivors' self-efficacy and outcome expectation of performing self-management behaviours. Secondary outcomes include health-related quality of life, satisfaction with performance of self-management behaviours, depressive symptoms, and community reintegration. Participants will be assessed at baseline and at 8 weeks after randomisation. Generalised estimating equations will be performed to evaluate the significance of changes in outcomes over time by treatment condition. Research ethics approvals were obtained.It is expected that stroke survivors receiving the stroke self-management programme will have improved self-efficacy, outcome expectation, and performance of stroke self-management behaviours. Enhanced quality of life and level of community reintegration, and decreased depressive symptoms are also expected. The study results will provide valuable evidence to inform future identification and evaluation of best approach to deliver stroke self-management programmes to enhance community-residing stroke survivors' recovery.ClinicalTrials.gov identifier: NCT02112955 ; date of registration: 09/04/2014.

SUBMITTER: Lo SH

PROVIDER: S-EPMC4986193 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors.

Lo Suzanne Hoi Shan SH Chang Anne Marie AM Chau Janita Pak Chun JP

BMC health services research 20160815 a

<h4>Background</h4>Recovery after stroke is long-term and demanding. Optimising community-residing stroke survivors' capability to self-manage their health is integral. Recent systematic reviews have shown that stroke self-management programmes were associated with significant improvement in stroke survivors' health-related quality of life and self-efficacy. However some programmes were not designed with an underpinning theoretical framework. The aim of this study is to compare the effectiveness ...[more]

PMID: 27528049

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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:IntroductionPoor recovery of the upper limb following a stroke has been recognised as a significant problem in the UK. Although there is good evidence that early, intense rehabilitation can lead to upper limb recovery, often this is not maintained, with less than 50% of people regaining the ability to use their upper limb for independent function at 6 months. Upper limb recovery potential is reported for many years poststroke, yet current long-term provision is insufficient.Methods and analysis60 participants will be recruited into this feasibility study, with 30 allocated to a Post Rehabilitation Enablement Programme (PREP) alone and 30 allocated to a combined programme, PREP Plus, consisting of PREP and the Graded Repetitive Arm Supplementary Programme (GRASP). We will aim to complete four iterative waves. Within each wave, the intervention design will be refined, based on participant feedback. Within each wave, there will be one cluster unit (one intervention group ;PREP Plus) and one control group ;PREP alone)). A total of five PREP sites within Northern Ireland Health and Social Care Trusts will be used for this study. PREP Plus will have a home exercise component along with exercises logs and a behaviour contract. Qualitative and quantitative measures will evaluate the acceptability and feasibility to determine how feasible it is to embed the intervention into practice, as well as to determine the feasibility of a larger, mixed-methods, randomised controlled trial to assess intervention efficacy. Clinical endpoints will also be explored.Ethics and disseminationThis study has been approved by the Health and Social Care Research Ethics Committee A, IRAS project ID (278620). Participants will provide informed consent prior to participating in the study. Information outlining the purpose of the study, what data will be collected and how the data will be managed will be provided. Results will be published in peer-reviewed journals and any published data will be available on the university data repository. The project management group will advise on different avenues for dissemination to ensure it reaches appropriate audiences.Trial registration numberNCT05090163.

Project description:BackgroundMany countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.MethodsWe did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866.FindingsBetween June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention.InterpretationAdding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.FundingDepartment of Health Policy Research Programme.

Project description:IntroductionLimited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA).MethodsProspective sub-study of the Shared Team Approach between Nurses and Doctors for Improved Risk Factor Management, a randomized controlled trial of risk factor management. We recruited patients aged ≥18 years and hospitalized for stroke/TIA. The intervention comprised an individualized management program, involving nurse-led education, and management plan with medical specialist oversight. The outcome, participants' knowledge of secondary prevention medications at 12 months, was assessed using questionnaires. A score of ≥5 was considered as good knowledge. Effectiveness of the intervention on knowledge of medications was determined using logistic regression.ResultsBetween May 2014 and January 2015, 142 consecutive participants from the main trial were included in this sub-study, 64 to usual care and 78 to the intervention (median age 68.9 years, 68% males, and 79% ischemic stroke). In multivariable analyses, we found no significant difference between intervention groups in knowledge of medications. Factors independently associated with good knowledge (score ≥5) at 12 months included higher socioeconomic position (OR 4.79, 95% CI 1.76, 13.07), greater functional ability (OR 1.69, 95% CI 1.17, 2.45), being married/living with a partner (OR 3.12, 95% CI 1.10, 8.87), and using instructions on pill bottle/package as an administration aid (OR 4.82, 95% CI 1.76, 13.22). Being aged ≥65 years was associated with poorer knowledge of medications (OR 0.24, 95% CI 0.08, 0.71), while knowledge was worse among those taking three medications (OR 0.15, 95% CI 0.03, 0.66) or ≥4 medications (OR 0.09, 95% CI 0.02, 0.44), when compared to participants taking fewer (≤2) prevention medications.ConclusionThere was no evidence that the nurse-led intervention was effective for improving knowledge of secondary prevention medications in patients with stroke/TIA at 12 months. However, older patients and those taking more medications should be particularly targeted for more intensive education.Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12688000166370).

Project description:INTRODUCTION:Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care. METHODS AND ANALYSIS:Improving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation. ETHICS AND DISSEMINATION:Favourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan. TRIAL REGISTRATION NUMBER:NCT03353519.

Project description:BackgroundThe Nurses in the Lead (NitL) programme consists of a systematic approach and training to 1) empower community nurses in implementing evidence, targeted at encouraging functional activities of older adults, and 2) train community nurses in enabling team members to change their practice. This article aims to describe the process evaluation of NitL.MethodsA mixed-methods formative process evaluation with a predominantly qualitative approach was conducted. Qualitative data were collected by interviews with community nurses (n = 7), focus groups with team members (n = 31), and reviewing seven implementation plans and 28 patient records. Quantitative data were collected among community nurses and team members (N = 90) using a questionnaire to assess barriers in encouraging functional activities and attendance lists. Data analysis was carried out through descriptive statistics and content analysis.ResultsNitL was largely executed according to plan. Points of attention were the use and value of the background theory within the training, completion of implementation plans, and reporting in patient records by community nurses. Inhibiting factors for showing leadership and encouraging functional activities were a lack of time and a high complexity of care; facilitating factors were structure and clear communication within teams. Nurses considered the systematic approach useful and the training educational for their role. Most team members considered NitL practical and were satisfied with the coaching provided by community nurses. To optimise NitL, community nurses recommended providing the training first and extending the training. The team members recommended continuing clinical lessons, which were an implementation strategy from the community nurses.ConclusionsNitL was largely executed as planned, and appears worthy of further application in community care practice. However, adaptations are recommended to make NitL more promising in practice in empowering community nurse leadership in implementing evidence.

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Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors.

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Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors.

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