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Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial
DiscussionThis is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one church in almost every neighborhood in the USA, churches have the ability and reach to play an important role in the dissemination and translation of stroke prevention programs in minority communities.Trial registrationNCT01909271; July 22, 2013
Source: Trials - April 19, 2015 Category: Journals (General) Authors: Joseph RavenellEllyn Leighton-HerrmannAmparo Abel-BeyAlexandra DeSorboJeanne TeresiLenfis ValdezMadeleine GordilloWilliam GerinMichael HechtMildred RamirezJames NobleElizabeth CohnGiardin Jean-LouisTanya SpruillSalina WaddyGbenga OgedegbeOlajide Williams Source Type: research

Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial
This study is designed to evaluate the comparative effectiveness, cost-effectiveness and sustainability of these two telehealth interventions in reducing BP and recurrent stroke among high-risk Black and Hispanic stroke survivors with uncontrolled hypertension.Methods/DesignA total of 450 Black and Hispanic patients with recent nondisabling stroke and uncontrolled hypertension are randomly assigned to one of two 12-month interventions: 1) HBPTM with wireless feedback to primary care providers or 2) HBPTM plus individualized, culturally-tailored, telephone-based NCM. Patients are recruited from stroke centers and primary ca...
Source: Trials - March 15, 2015 Category: Journals (General) Authors: Tanya SpruillOlajide WilliamsJeanne TeresiSusan LehrerLiliana PezzinSalina WaddyRonald LazarStephen WilliamsGirardin Jean-LouisJoseph RavenellSunil PenesettiAlbert FavateJudith FloresKatherine HenryAnne KleimanSteven LevineRichard SinertTeresa SmithMichel Source Type: research

Translating knowledge for action against stroke – using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke)
DiscussionMovies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems.Trial registrationNCT02202330 (28 January 2015)
Source: Trials - January 27, 2016 Category: Journals (General) Authors: Ayeesha KamalAdeel KhojaBushra UsmaniAbdul MuqeetFabiha ZaidiMasood AhmedSaadia ShakeelNabila SoomroAmbreen GowaniNargis AsadAsma AhmedSaleem SayaniIqbal AzamSarah Saleem Source Type: research

Randomized controlled pilot study of a SystemCHANGETM weight management intervention in stroke survivors: rationale and protocol
This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGETM approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors.Trial registration: ClinicalTrials.gov Identifier: NCT01776034
Source: Trials - May 7, 2013 Category: Journals (General) Authors: Matthew PlowShirley MooreJohn KirwanFredrick FrostIrene KatzanSue JaegerJay Alberts Source Type: research

Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan
Conclusions: The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP.Trial registration: Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.
Source: Trials - October 1, 2014 Category: Journals (General) Authors: Willeke WestendorpJan-Dirk VermeijDiederik DippelMarcel DijkgraafTom van der PollJan PrinsFrederique VermeijYvo RoosMatthijs BrouwerAeilko ZwindermanDiederik van de BeekPaul Nederkoorn Source Type: research

Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial
This study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes.Trial registrationCl...
Source: Trials - January 27, 2015 Category: Journals (General) Authors: Penny FeldmanMargaret McDonaldMelissa TrachtenbergAntoinette SchoenthalerNoreen CoyneJeanne Teresi Source Type: research

Primary prevention for risk factors of ischemic stroke with Baduanjin exercise intervention in the community elder population: study protocol for a randomized controlled trial
This study will be the randomized trial to evaluate the effectiveness of Baduanjin exercise for primary prevention of stroke in community elder population with high risk factors of stroke. The results of this trial will help to establish the optimal approach for primary prevention of stroke.Trial registration: Chinese Clinical Trial Registry: ChiCTR-TRC-13003588.Registration date: 24 July, 2013.
Source: Trials - April 9, 2014 Category: Journals (General) Authors: Guohua ZhengBai ChenQianying FangHongmei YiQiu LinLidian ChenJing TaoJunzhe LiXin ZhengMoyi LiXiulu Lan Source Type: research

Automated real-time text messaging as a means for rapidly identifying acute stroke patients for clinical trials
Conclusions: The system proved to be stable in generating text messages using IT-based CIS to identify acute stroke trial patients. The system operated on information which is documented routinely and did not result in a higher workload. Delays between patient admission and the text message were caused by delayed completion of basic documentation. To use the automated real-time text messaging system to immediately identify emergency patients suitable for acute stroke trials, further development needs to focus on eliminating delays in documentation for the SSA in the emergency department.
Source: Trials - July 29, 2014 Category: Journals (General) Authors: Kati JegzentisTim NowePeter BruneckerMatthias EndresBernd HaferkornChristoph PlonerJens SteinbrinkGerhard Jungehulsing Source Type: research

Head Position in Stroke Trial (HeadPoST) – sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial
DiscussionHeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.Trial registrationClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.
Source: Trials - June 5, 2015 Category: Journals (General) Authors: Paula Muñoz-VenturelliHisatomi ArimaPablo LavadosAlejandro BrunserBin PengLiying CuiLily SongLaurent BillotElizabeth BoadenMaree HackettStephane HeritierStephen JanSandy MiddletonVerónica OlavarríaJoyce LimRichard LindleyEmma HeeleyThompson RobinsonOct Source Type: research

The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes
Conclusions: Our results suggest that, under the given treatment effect scenarios, the decision whether or not to adjust for baseline severity when using a responder analysis outcome should be guided by the needs of the study, as type I error rates and power do not appear to vary largely between the methods. These findings are applicable to stroke trials which use the mRS for the primary outcome, but also provide a broader insight into the analysis of binary outcomes that are defined based on baseline prognostic variables.Trial registration: This research is part of the Stroke Hyperglycemia Insulin Network Effort (SHINE) t...
Source: Trials - April 11, 2013 Category: Journals (General) Authors: Kyra GarofoloSharon YeattsViswanathan RamakrishnanEdward JauchKaren JohnstonValerie Durkalski Source Type: research

Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial
DiscussionThis trial is the first to evaluate the efficacy of MSCs in patients with ischemic stroke. The results may provide better evidence for the effectiveness of MSC therapy in patients with ischemic stroke.Trial registrationThis trial was registered with ClinicalTrials.gov, number NCT01716481.
Source: Trials - October 1, 2013 Category: Journals (General) Authors: Suk Jae KimGyeong Joon MoonWon Hyuk ChangYun-Hee KimOh Young Bang Source Type: research

Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids
Background: Stroke is a common cause of cognitive impairment and dementia. However, effective strategies for reducing the risk of post-stroke dementia remain undefined. Potential strategies include intensive lowering of blood pressure and/or lipids. Methods: Design: multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial phase IV trial in secondary and primary care.Participants: 100 participants from 30 UK Stroke Research Network sites who are post- ischemic stroke or intracerebral haemorrhage by three to seven months.Interventions - all patients (1:1): intensive versus guideline blood ...
Source: Trials - November 22, 2013 Category: Journals (General) Authors: Daniel BlackburnKailash KrishnanLydia FoxClive BallardAlistair BurnsGary FordJonathan MantPeter PassmoreStuart PocockJohn RecklessNikola SpriggRob StewartJoanna WardlawPhilip Bath Source Type: research

Physical fitness training in Subacute Stroke (PHYS-STROKE) - study protocol for a randomised controlled trial
DiscussionThe goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention.Trial registration: Registered in ClinicalTrials.gov with the Identifier NCT01953549.
Source: Trials - February 3, 2014 Category: Journals (General) Authors: Agnes FlöelCordula WernerUlrike GrittnerStefan HesseMichael JöbgesJanet KnaussMichael SeifertElisabeth Steinhagen-ThiessenMehmet GövercinChristian DohleWolfgang FischerRegina SchliederAlexander NaveAndreas MeiselMartin EbingerIan Wellwood Source Type: research

The Stroke Oxygen Study (SO2S) - a multi-center, study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trial
This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen.Trial registration: This trial is registered with the ISRCTN register ID number ISRCTN52416964
Source: Trials - March 31, 2014 Category: Journals (General) Authors: Christine RoffeTracy NevattePeter CromeRichard GrayJulius SimSarah PountainLinda HandyPeter Handy Source Type: research

Supported cognitive-behavioural self-help versus treatment-as-usual for depressed informal carers of stroke survivors (CEDArS): study protocol for a feasibility randomized controlled trial
This study is a Phase II (feasibility) randomized controlled trial (RCT) following guidance in the MRC Complex Interventions Research Methods Framework. We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals, or treatment-as-usual. Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes: a) feasibility of patient recruitment (recruitment and refusal rates); (b) feasibility and acceptability of data collection procedures; (c) l...
Source: Trials - May 6, 2014 Category: Journals (General) Authors: Joanne WoodfordPaul FarrandEdward WatkinsDavid RichardsDavid Llewellyn Source Type: research

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