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Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan.

ABSTRACT: Introduction: Stroke can lead to life-long disability and constitutes a huge financial burden on the family and society. Stroke survivors with cognitive impairment often experience considerable challenges in the process of recovery and returning to society. Interventions that effectively help individuals resume essential daily activities and return to active participation in their communities are lacking. This study examines the efficacy of a newly-developed intervention programme, the Optimising Participation after Stroke through Strategy-training (OPASS) programme, for improving community participation among stroke survivors with cognitive impairment.

Methods and analysis: A single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding will be implemented to assess the efficacy of the OPASS programme. An expected 210 adults with cognitive impairment following stroke will be randomly assigned to either the experimental intervention (OPASS) group or the attention control group. In addition to their usual rehabilitation, both groups will receive 45?min sessions, twice weekly for a total of 12-15 sessions. The primary outcome is change in participation performance, which will be measured using the participation measure-three domains, four dimensions scale. Additional measures include the Activity Measure for Post-Acute Care generic outpatient short forms, Montreal Cognitive Assessment, Stroop Test, Trail Making Test and General Self-Efficacy Scale. These scales will be administered at baseline, post-intervention, 3-month follow-up, 6-month follow-up and 12-month follow-up. Their results will be analysed using multiple linear regression models and mixed-effects regression models. Further assessment of feasibility and acceptability of the intervention will be conducted through structured interviews with participants, caregivers and therapists. These interviews will be transcribed and thematically analysed.

Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N201804055). The findings will be disseminated through presentations at scientific conferences and through publication in peer-reviewed journals.

Trial registration number: NCT03792061; pre-results.

SUBMITTER: Chang FH

PROVIDER: S-EPMC7722819 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan.

Chang Feng-Hang FH Chiu Valeria V Ni Pengsheng P Lin Yen-Nung YN Kang Jiunn-Horng JH Liou Tsan-Hon TH Lu Lu L Han Der-Sheng DS Skidmore Elizabeth R ER

BMJ open 20201207 12

<h4>Introduction</h4>Stroke can lead to life-long disability and constitutes a huge financial burden on the family and society. Stroke survivors with cognitive impairment often experience considerable challenges in the process of recovery and returning to society. Interventions that effectively help individuals resume essential daily activities and return to active participation in their communities are lacking. This study examines the efficacy of a newly-developed intervention programme, the Op ...[more]

PMID: 33293312

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Project description:IntroductionStudies show that stroke survivors encounter physical and psychological limitations that restrict their participation in social and community activities. Systematic reviews have yielded inconclusive evidence regarding the effectiveness of different interventions intended to support stroke survivors' social participation. Recent advances in virtual reality technology may offer promising solutions, although the optimal approach to enhance social participation among stroke survivors is yet to be determined. This trial aims to develop and evaluate the effectiveness of a social participation-focused virtual reality (SP-VR) intervention on the physical, psychological and social outcomes of community-dwelling stroke survivors with physical disabilities.Methods and analysisA two-arm randomised, controlled, assessor-blind clinical trial will be conducted with 250 stroke survivor-caregiver dyads recruited from three acute and one rehabilitation hospitals, and three stroke nurse-led clinics. Participants will be survivors of a first or recurrent stroke within 6 months of stroke onset and able to remain in a sitting position without support, and their primary caregivers. Eligible participants will be randomly allocated to receive the SP-VR intervention or usual care which includes conventional physical therapy services. The intervention group will receive a newly developed 6-week novel custom-made SP-VR application comprising two sessions weekly. Three SP-VR modules will cover key aspects of survivors' social health needs, namely functional rehabilitation, social participation, and social interaction and recreation. The primary outcome for stroke survivors is social participation, and secondary outcomes include depressive symptoms, participation self-efficacy, physical function, functional mobility and social support. User satisfaction will be evaluated among both survivors and caregivers. Data will be collected in person at baseline, immediately after, and 3 months postintervention.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Research Ethics Committee (Ref. No.: 2019.676). Study results will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberChiCTR2100050850.

Project description:IntroductionThe STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.Methods and analysisIn a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.Ethics and disseminationThe study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.Trial registration numberACTRN12617000745347; Pre-results.

Project description:INTRODUCTION:Stroke is one of the primary causes of death and disability worldwide, leaving a considerable proportion of survivors with persistent cognitive and functional deficits. Despite the prevalence of poststroke cognitive impairment, there is no established treatment aimed at improving cognitive function following a stroke. Therefore, the aims of this systematic review are to identify psychological interventions intended to improve poststroke cognitive function and establish their efficacy. METHODS AND ANALYSIS:A systematic review of non-randomised controlled studies that investigated the efficacy of psychological interventions aimed at improving cognitive function in stroke survivors will be conducted. Electronic searches will be performed in the PubMed, Embase and PsycINFO databases, the search dating from the beginning of the index to February 2017. Reference lists of all identified relevant articles will be reviewed to identify additional studies not previously identified by the electronic search. Potential grey literature will be reviewed using Google Scholar. Titles and abstracts will be assessed for eligibility by one reviewer, with a random sample of 50% independently double-screened by second reviewers. Any discrepancies will be resolved through discussion, with referral to a third reviewer where necessary. Risk of bias will be assessed with the Risk of Bias in Non-randomized Studies of Interventions tool. Meta-analyses will be performed if studies are sufficiently homogeneous. This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of the evidence regarding cognitive function will be assessed according to the Grading of Recommendations Assessment, Development and Evaluation. ETHICS AND DISSEMINATION:This systematic review will collect secondary data only and as such ethical approval is not required. Findings will be disseminated through presentations and peer-reviewed publication. This review will provide information on the effectiveness of psychological interventions for poststroke cognitive impairment, identifying which psychological interventions are effective for improving poststroke cognitive function. PROSPERO REGISTRATION NUMBER:CRD42017069714.

Project description:PurposeUp to 70% of survivors report cognitive symptoms after chemotherapy. We compared two cognitive rehabilitation programs to a control group in cancer survivors.MethodsStudy population were adult cancer survivors with cognitive symptoms 6-60 months after adjuvant chemotherapy. Participants randomised to: Attention Process Training (APT), Compensatory Strategy Training (CST), or control group. Active interventions comprised 6-week, 2-h/week small group sessions.Assessmentspre- and post-intervention, 6- and 12-months later. Primary outcome was change in cognitive symptoms (FACT-COG-PCI subscale) between baseline and post-intervention. Secondary endpoints included objective neuropsychological performance, Functional Impact Assessment (FIA), patient-reported outcome measures, and associations. Analyses were on an intention-to-treat basis. Analysis of covariance mixed models were used for continuous outcomes.ResultsSixty-five participants were randomised (APT n = 21; CST n = 24; controls n = 20): 94% breast cancer, median age 54. Median time since chemotherapy 20.7 months. FACT-COG-PCI, clinical neuropsychological T-scores, and FIA improved in all groups over time, but no significant differences between arms. On mean neuropsychological T-scores 19/65 (29%) were impaired at baseline; post-intervention impairment controls 31.3%, CST 16.7%, APT 20.0%. On FIA at baseline, nine were impaired; this decreased to three post-intervention (one/group). FACT-COG-PCI was weakly associated with neuropsychological tests (rho = 0.24, p = 0.051) at baseline, and had no association with FIA. Neuropsychological total mean T-score was moderately positively associated with FIA (rho = 0.37, p = 0.003).ConclusionThere were no significant differences between intervention groups and controls using linear mixed models adjusted for baseline scores.Implications for cancer survivorsCognitive symptoms and neuropsychological test scores improve over time.

Project description:IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.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.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

Project description:BackgroundRecovery 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.Methods/designA 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.DiscussionIt 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.Trial registrationClinicalTrials.gov identifier: NCT02112955 ; date of registration: 09/04/2014.

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.

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Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan.

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Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan.

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