BioMed CentralBMC Cardiovascular Disorders ssOpen AcceStudy protocolHome-based exercise rehabilitation in addition to specialist heart failure nurse care: design, rationale and recruitment to the Birmingham Rehabilitation Uptake Maximisation study for patients with congestive heart failure (BRUM-CHF): a randomised controlled trialKate Jolly*1, Rod S Tayor2, Gregory YH Lip3, Sheila M Greenfield4, Michael K Davies5, Russell C Davis6, Jonathan W Mant4, Sally J Singh7, Jackie T Ingram4, Jane Stubley6 and Andrew J Stevens1Address: 1Department of Public Health & Epidemiology, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK, 2Peninsula Medical School, University of Exeter, EX2 5DW, UK, 3University Department of Medicine, City Hospital, Dudley Road, Birmingham, B18 7QH, UK, 4Department of Primary Care & General Practice, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK, 5Department of Cardiology, University Hospital Birminghan NHS Trust, Birmingham, B15 2TH, UK, 6Sandwell and West Birmingham NHS Trust, Lyndon, West Bromwich, West Midlands, B71 4HJ, UK and 7Dept Cardiac and Pulmonary Rehabilitation, University Hospitals of Leicester, UKEmail: Kate Jolly* - c.b.jolly@bham.ac.uk; Rod S Tayor - rod.taylor@pms.ac.uk; Gregory YH Lip - G.Y.H.Lip@bham.ac.uk; Sheila M Greenfield - S.M.Greenfield@bham.ac.uk; Michael K Davies - michael.davies@uhb.nhs.uk; Russell C Davis - Russell.davis@swbh.nhs.uk; Jonathan W Mant - J.W.mant@bham.ac.uk; Sally J Singh - S.Singh@uhl-tr.nhs.uk; Jackie T Ingram - J.T.Ingram@bham.ac.uk; Jane Stubley - jane.stubley@swbh.nhs.uk; Andrew J Stevens - A.J.Stevens@bham.ac.uk* Corresponding author AbstractBackground: Exercise has been shown to be beneficial for selected patients with heart failure, butquestions remain over its effectiveness, cost-effectiveness and uptake in a real world setting. Thispaper describes the design, rationale and recruitment for a randomised controlled trial that willexplore the effectiveness and uptake of a predominantly home-based exercise rehabilitationprogramme, as well as its cost-effectiveness and patient acceptability.Methods/design: Randomised controlled trial comparing specialist heart failure nurse care plus anurse-led predominantly home-based exercise intervention against specialist heart failure nursecare alone in a multiethnic city population, served by two NHS Trusts and one primary care setting,in the United Kingdom.169 English speaking patients with stable heart failure, defined as systolic impairment (ejectionfraction ≤ 40%). with one or more hospital admissions with clinical heart failure or New York HeartAssociation (NYHA) II/III within previous 24-months were recruited.Main outcome measures at 1 year: Minnesota Living with Heart Failure Questionnaire, incrementalshuttle walk test, death or admission with heart failure or myocardial infarction, health careutilisation and costs. Interviews with purposive samples of patients to gain qualitative informationabout acceptability and adherence to exercise, views about their treatment, self-management oftheir heart failure and reasons why some patients declined to participate.Published: 7 March 2007BMC Cardiovascular Disorders 2007, 7:9 doi:10.1186/1471-2261-7-9 Received: 29 November 2006Accepted: 7 March 2007This article is available from: http://www.biomedcentral.com/1471-2261/7/9© 2007 Jolly et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Page 1 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9The records of 1639 patients managed by specialist heart failure services were screened, of which997 (61%) were ineligible, due to ejection fraction>40%, current NYHA IV, no admission or NYHAII or more within the previous 2 years, or serious co-morbidities preventing physical activity. 642patients were contacted: 289 (45%) declined to participate, 183 (39%) had an exclusion criterionand 169 (26%) agreed to randomisation.Discussion: Due to safety considerations for home-exercise less than half of patients treated byspecialist heart failure services were eligible for the study. Many patients had co-morbiditiespreventing exercise and others had concerns about undertaking an exercise programme.BackgroundHeart failure is a major cause of morbidity and mortalityin westernised societies and has a poor prognosis [1-3]Patients with heart failure (HF) suffer from a variety ofsymptoms, many of which are non-specific and oftenresult in a poor quality of life[4], with decreased exercisecapacity being the main factor restricting daily activity.Heart failure management in the UK is currently undergo-ing major changes as a result of evidence showing the ben-efits of specialist nurses in reducing hospitalreadmissions[5,6] Specialist heart failure nurses fundedboth by the British Heart Foundation and by local primarycare trusts are becoming part of the accepted standard ofcare for patients with heart failure. Specialist heart failurenurses do not currently provide structured exercise train-ing[6,7].Effectiveness of exercise rehabilitationFour systematic reviews have addressed the effectivenessof exercise training for patients with heart failure [8-11]. Aqualitative review in 2002 concluded that short-term exer-cise training in selected sub-groups of patients led toshort-term improvements on quality of life and had somephysiological benefits[8]. However, it was noted thatmost trials were of short duration, small scale andfocussed on physiological changes rather than morbidityand mortality. They also had included a patient profilethat is not representative of typical heart failure patients,being younger, predominantly male and without co-mor-bidities[8].A Cochrane review which included 1126 patients in 29randomised controlled trials (RCT) concluded that forpatients with New York Heart Association (NYHA) class IIor III heart failure, exercise training improved exercisecapacity and quality of life in the short-term. Improve-ments in exercise capacity were greater in programmes ofgreater intensity and longer duration[10]. One study[11]using an end point of combined events and mortalityfound no difference in combined events (death or adverseevents) in the exercise group (OR 0.98; 95% CI 0.61 to1.32) compared to the control group. There was a non-sig-nificant trend towards a reduction in mortality (OR 0.71; 95% CI 0.37 to 1.02, p = 0.06)[11]. The ExTraMATCH col-laboration undertook an individual patient data meta-analysis by combining the datasets from eight RCTs witha total of 801 patients[9]. This had access to longer-termfollow-up data than was available to the previous meta-analyses and showed an overall reduction in mortality inthe patients who received the exercise intervention (haz-ard ratio 0.65; 95% CI 0.42 to 0.92)[9].Only one trial has compared exercise training in patientswith a control group receiving a specialist heart failurenurse intervention[12]. This evaluated an eight-week hos-pital rehabilitation programme including exercise andeducation followed by a 16 week community supervisedexercise programme in patients referred to a specialistheart failure nurse and reported significant improvementsat 24 week follow-up in the Minnesota Living with HeartFailure Questionnaire (MLwHF) and EuroQol scores, theNew York Heart Association (NYHA) class and distancewalked on the 6-minute walk between the rehabilitationand specialist heart failure nurse care only[12]. The exer-cise intervention occurred at the same time as medicationwas optimised and there was a higher proportion ofpatients in the intervention arm on beta-blockade, whichmay have accounted for some of the difference. In addi-tion the rehabilitation programme included an educa-tional component and was not solely exercise-based.Mechanism of action of exerciseThe majority of trials of exercise in patients with heart fail-ure have reported physiological improvements, which aremainly due to peripheral adaptations [13-18] There issome evidence that exercise increases cardiac stroke vol-ume[16,19-21] and reduces cardiomegaly[16]. Exercisetraining has been shown to lower resting heart rate andimprove myocardial perfusion[22]. The mechanisms ofthese actions include an improvement in the neurohor-monal abnormalities seen in heart failure, enhanced vagaltone, and changes in skeletal muscle type and function[13]. Favourable changes in the indices of heart rate vari-ability have been reported, which indicates improvedautonomic control of heart rate and has been associatedwith improved survival[23]. However, trials of exerciseinterventions rarely report data on the extent to whichPage 2 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9medication use changed, which would have affected theoutcomes.Type of exercise and settingsCurrent recommendations for exercise training are basedon experiences from a limited number of randomisedcontrolled trials that have enrolled highly selectedpatients. Questions remain about the optimal trainingmodality and intensity[24] but current evidence suggeststhat training should include aerobic and resistance com-ponents. Peripheral muscles should be trained without asignificant increase in cardiovascular stress[25], usingintermittent exercise and/or sequential training.Whilst the National Service Framework for coronary heartdisease suggests that cardiac rehabilitation should be con-sidered for patients with heart failure[26], it is rarely pro-vided in the UK. Indeed, there are no published data onthe uptake and acceptability of exercise-based rehabilita-tion for heart failure, but poor uptake post myocardial inf-arction (MI) occurs particularly in women, the elderly andpatients from minority ethnic groups [27-31]. and theprofile of patients with heart failure is older and includesmore women than is the case for MI. Only one entirelyhome-based exercise intervention trial (20 patients inhome arm) has been reported, with significant improve-ments in quality of life compared to patients receivingusual care[32].Rationale for Birmingham Rehabilitation Uptake Maximisation study for patients with congestive heart failure (BRUM-CHF) studyWhilst there are a number of very small trials of exerciseinterventions for patients with heart failure, questionsremain about the effectiveness of exercise interventionsoutside specialist research units and in a representativepatient population[24]. The follow-up period needed tobe of sufficient duration to measure hospital admissionsand mortality. In addition, apart from one trial[12], thereported trials of exercise rehabilitation were all comparedto 'usual care'. The latter provided in these control arms isinferior to the specialist heart failure nurse interventionnow offered as part of modern heart failure managementprogrammes. There is also no evidence as to whether theimprovements in quality of life and mortality in the exer-cise intervention groups in the published trials, are a resultof physiological improvements or from the close clinicalmonitoring received alongside the exercise. It may also bethat lifestyle and drug management advice was impartedwith the exercise intervention and these improvementswould now result from the specialist nurse intervention.The cost-effectiveness of exercise interventions has beenaddressed by only one study[33], which had usual care asthe control group. This concluded that a long-term hospi- tal-based exercise programme for people with stable heartfailure was a cost-effective intervention[33].The BRUM-CHF study proposes to establish the addi-tional benefits of exercise rehabilitation compared to cur-rent care that includes specialist heart failure nurses.Given the potential problems with the capacity of the hos-pital service and uptake in a more elderly and debilitatedpopulation than other patients receiving cardiac rehabili-tation for MI or revascularisation, it will be important tohave information about effectiveness, uptake and compli-ance in a predominantly home-based setting.Study aimThe primary research question seeks to evaluate whetherthere are additional benefits from exercise rehabilitationover specialist heart failure nurse management and toestablish the cost-effectiveness and patient acceptability ofa predominantly home-based programme of exerciserehabilitation. In addition, the study will investigate thepatient experience of heart failure and rehabilitationwhilst attaining information about effectiveness, uptakeand compliance of patients in a predominantly home-based setting.Methods/DesignBRUM-CHF is a randomised controlled trial of exerciserehabilitation in heart failure comparing specialist heartfailure nurse care alone with specialist heart failure nursecare plus a structured exercise intervention.Prior to commencement of the study, ethical approval wasobtained from Sandwell and West Birmingham LocalResearch Ethics Committee (Reference number: 03/10/708).Randomisation was performed centrally by computer atthe Birmingham Cancer Clinical Trials Unit, University ofBirmingham. When a patient was identified as eligible forthe study, and had given written, informed consent to takepart, the research nurse telephoned the trials unit. The Tri-als Unit randomly allocated patients, using the method ofminimisation, stratified by (i) NYHA group, (ii) presenceor absence of atrial fibrillation and (iii) hospital site.In one arm patients continued with "usual" specialistheart failure nurse care. In the other arm patients contin-ued with "usual" specialist heart failure nurse care com-bined with the exercise programme. The trial design issummarised in Figure 1. Patients who refused randomisa-tion continued with their normal specialist nurse care.PopulationThe two NHS hospital Trusts and one Primary Care Trustfrom which patients were recruited are in the West Mid-Page 3 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9Page 4 of 9(page number not for citation purposes)Identification and recruitment of participants to the BRUM-CHF studyFigure 1Identification and recruitment of participants to the BRUM-CHF study.Reviewed for suitability(n=1639) Excluded (997)Not inclusive (468)Co-morbidities (193)Cardiac related (153)Miscellaneous (102)No English (77)Unable to recruit before study end (n = 4)Invitation to participate(n=642) Refusals (284)Exclusion (172):Ineligible (18)Co-morbidity (56)Cardiac related (22)Miscellaneous (45)No English (21)Unable to recruit before study end (10)Agreed to assessment(n=185) Declined to participate (n=5)Informed consent obtainedCollection of baseline data(n=181) Contraindicated at ISWT(n=12)Randomisation stratified by NYHA, AF and centre(n=169)Normal Heart Failure Nurse input only(n=85) Normal Heart Failure Nurse input and individualised exercise programme (n=84)6-month follow-upISWT and questionnaire12-month follow-upquestionnaire
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9lands, UK, covering a combined multiethnic populationof approximately one million with a high incidence ofheart disease. Recruited patients had left ventricular systo-lic dysfunction with an ejection fraction of 40% or lessmeasured quantitatively, or classed qualitatively as 'mod-erate to severe impairment' on an echocardiogram, andwere identified from three specialist heart failure nurseservices. Recruitment took place over 19 months. Inclu-sion and exclusion criteria are summarised in Table 1.Details of all patients referred to the specialist heart failureservices were collected and suitability for study participa-tion identified. Potentially eligible patients were con-tacted, invited to participate and assessed prior torandomisation by an incremental shuttle walk test (ISWT)to determine their suitability for exercise and to excludepatients with symptomatic ischaemia, cardiac arrhyth-mias or marked hypotension on exercise[34,35].Baseline data collected prior to randomisation includedthe NYHA class, left ventricular systolic ejection fraction,demographic details (age, sex, ethnicity), disease history(admissions for heart failure) and past medical history,current medication, and outcomes (see below).InterventionsSpecialist heart failure nurse care"Usual care" is that provided by primary and secondarycare with specialist heart failure nurse input. To ensurehomogeneity of the intervention received, especially inrelation to heart failure nurse input and receipt of optimalmedical treatment, patients were recruited from thosereferred to the specialist heart failure clinic. The heart fail-ure nurses had all undergone training from the BritishHeart Foundation. Exercise interventionThe exercise group received "usual care" as describedabove, plus an exercise programme which commencedwith three supervised exercise sessions to provide thepatient with confidence and to plan an individualisedexercise programme. This was followed by a home-basedprogramme with home visits at 4, 10 and 20 weeks, tele-phone support at 6, 15 and 24 weeks and a manual.The home programme was predominantly aerobic train-ing based largely on progressive walking with self-comple-tion activity logs. Exercise prescription was based uponthe participant's baseline exercise tolerance as measuredby the incremental shuttle walking test. Performance onthis test correlates well with peak VO2 [34,36] An individ-ually prescribed walking programme was identified fromthis test at a speed that corresponded to 70% of peak per-formance. During the first two weeks of rehabilitation thespeed of walking was secured by the patient with the helpof the rehabilitation team. Targets were set weekly for theduration and frequency of walks, which largely dependedon an individual's baseline exercise capacity. The pro-gramme aimed for the patients to achieve 20 to 30 min-utes of walking 5 times a week after 10 weeks ofrehabilitation. This was monitored with home trainingdiaries.Strength training was low intensity, using the patient'sown body weight for resistance. The focus of the strengthtraining was both upper and lower limb. The "milk bottleregime" currently used in the rehabilitation programme inLeicester are used. Patients complete sets of up to 10 rep-etitions of 8 key exercise using milk bottles filled withgradually increasing volumes (thus weights) of water. Tar-gets are set and level of difficulty assessed. Individual exer-Table 1: Inclusion and exclusion criteriaInclusion CriteriaAdmitted with decompensated heart failure or had heart failure of severity NYHA II or III within the past 24 monthsLVSF (left ventricular systolic function) with ejection fraction of <40% or moderate to severe impairment on 2D ECHOStable and compensated heart failure for at least 4 weeksExclusion CriteriaNYHA IVUnable to speak EnglishMI or revascularisation within the past 4 monthsCardiac rehabilitation within the past 6 monthsBP < 100 mmHg systolic, demonstrated postural hypotension, or fall in BP on exerciseDisabling CVA (stroke) within the past 6 monthsSevere musculoskeletal problems preventing exerciseUnstable anginaVentricular or symptomatic arrhythmiasObstructive aortic valvular disease with a gradient of > 35 mmHgHypertrophic obstructive cardiomyopathyDocumented severe chronic obstructive pulmonary disease requiring medicationCase-note reported dementia or current severe psychiatric disorder Page 5 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9cises are omitted in patients with particular needs ordifficulties.Specific support for the exercise intervention ceases aftersix months but patients are encouraged to continue tomaintain their activity levels.Outcome measuresFollow-up by postal questionnaire and clinical assess-ment occurs at 6 months and by postal questionnaire at 1year.The primary outcome measure is the Minnesota Livingwith Heart Failure Questionnaire (MLwHF) Question-naire[37]. Secondary outcome measures at 6 months are(i) composite of death or admission with heart failure ormyocardial infarction, (ii) admission with heart failure,(iii) mortality (all-cause and vascular), (iv) EuroQol[38],(v) HADS[39], (vi) blood pressure, (vii) self-reportedphysical activity, and (viii) distance walked on theISWT[36]. At 12 months the ISWT and blood pressuremeasurements are omitted.Process measures to determine the comparability of inter-vention received from the specialist heart failure serviceincluded self-reported smoking cessation, salt reductionand alcohol intake. Uptake and adherence to the exerciseintervention are assessed by (i) attendance at the hospitaltraining sessions, and (ii) patient completed exercise dia-ries at 4, 10 and 20 weeks in the intervention group.The study could not be double blind because of the natureof the intervention. To reduce the potential for bias inmeasuring outcomes in the questionnaires we used vali-dated measurement tools and aimed for clinical follow-upto be undertaken by an individual who had not providedthe rehabilitation support and was blinded to treatmentallocation. Determination of secondary end-points (hos-pitalisation for heart failure and vascular mortality) wasby an independent committee blinded to treatment allo-cation.Sample SizeThe overall power of the trial was determined on the basisof the primary outcome – health related quality of life.To detect a 10 point difference between the 'usual care'and supervised exercise group on the MLwHFQ (13 pointsat 1 year in Belardinelli)[22] at the 5% significance levelwith 80% power, 140 evaluable subjects at 1 year wereneeded. Allowing for 20% mortality and loss to follow-upa total of 168 recruits (84 per group) were needed. Statistical analysisAll data will be analysed by intention to treat. Compari-sons between the primary outcome measure will be madeat two separate time points: 6 months and 1 year to assessboth short and long-term effects of the exercise interven-tion.For outcomes measured on a continuous scale (MLwHFquestionnaire, HADS, Euroqol, blood pressure, self-reported physical activity, distance walked on ISWT), dif-ferences between the two groups will be investigated usinga least squares regression framework. Differences in timerelated clinical outcomes (hospital readmission rates,mortality and composite of these) will be analysed usingthe Kaplan-Meier survival method and the two groupscompared by the Log-Rank test. Multivariate regressionmethods will be used to take into account the baselinemeasurements for each patient. When baseline informa-tion is available this provides a more precise estimate ofthe treatment effect than either raw outcomes or changescores[40]. Results will be expressed as means and 95%confidence intervals.Qualitative studyThe qualitative part of the study seeks to explore whatpatients with heart failure understand about their condi-tion and what they think the role and potential outcomesof exercise are. The results of the qualitative study willcomplement and contextualise the quantitative findingse.g. people who do not take part may hold negative viewsabout exercise or that it is dangerous, particularly in ahome environment.Interviews will be sought with purposive samples of (i)patients who declined to take part in the study, shortlyafter they have been invited; (ii) patients and their carerswho were randomised to both exercise and controlgroups: during the exercise programme and at 6 monthsafter recruitment.We will use a maximum variety sample that represents thebroadest range of social characteristics[41]. As the processof this type of research is iterative and reflexive it enablesrefinement of the course of enquiry in response to emerg-ing findings i.e. new ideas mentioned by interviewedpatients are integrated with current knowledge as theinterviews progress and are included in subsequent inter-views. This process is continued until interviewing is nolonger generating new concepts and interviewing stops atthis stage (i.e. theoretical saturation)[42]. To reach thisstage it is generally estimated that between 20 and 30interviews per group are necessary[43]. Page 6 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9Economic analysisThe costs of the alternative programmes will be assessedfrom two perspectives: NHS and societal. NHS costs willbe based on resource inputs (time with the exercise reha-bilitation nurse, travel time, drugs, use of NHS resourcesincluding any differences in hospital admissions linked toheart failure) costed up to include labour and overheadcosts. National average unit costs will be used with explo-ration of local differences in sensitivity analysis. A cost-effectiveness analysis will be undertaken based on the out-come measures described above, with particular emphasison deriving estimates of the incremental cost per QALY.Utility values will be based on the EQ-5D (or EuroQol)and life years from the mortality analysis described above.Modelling will be used to extrapolate from the trial (bothin time and by unit cost) and for sensitivity analyses.Resource use data will be collected as part of the overalldata collection procedures. Bootstrapping will be used toexplore differences in costs. Cost effectiveness results willbe presented in the form of acceptability curves.RecruitmentThe clinical notes of 1639 patients referred to the special-ist heart failure nurse services were reviewed. Of these 997(60.8%) were deemed not eligible, or had an exclusioncriterion identifiable from the records (table 2). 468(50.4%) had not been of NYHA class II or III or admittedwith decompensated heart failure within the previous 24months, or had an ejection fraction greater than 40%. Afurther 153 (15.3%) had a cardiac exclusion criterion, 204(20.4%) a co-morbid condition precluding a home exer-cise programme.The remaining 642 (39%) of patients were contacted byletter and invited to participate in the study once theirheart failure was stable, and they were on maximised beta-blocker therapy. At this stage a further 172 (10.5% of totalsample) were excluded and 284 (17.3%) declined to par-ticipate (figure 1).The remaining 186 (12% of all initially reviewed patients)agreed to participate in the study, 2% of these failed toattend the assessment or changed their mind at assess-ment. The remaining 181 patients all gave written andinformed consent and were assessed by incremental shut-tle walk test for suitability before randomisation. We iden-tified contraindication to home exercise in 12 of theassessed patients at the ISWT. Overall, only 10% of all cur-rently alive patients referred to the three heart failurenurse services in the two years prior to commencing thestudy and during the 19 months of recruitment were actu-ally randomised. DiscussionThe BRUM-CHF study is novel in its evaluation of a pre-dominantly home-based, structured exercise programmefor patients with heart failure also receiving specialistheart failure nurse support. Recruitment to the trial hashighlighted that such an exercise programme will beappropriate for a minority of patients with heart failure.The majority of patients seen by the specialist heart failureservice were not eligible for the trial, due to factors thatincluded insufficient or too severe disease severity or pre-clusion of safe home exercise. In addition, co-morbiditiesaccounted for large numbers of patients not being suitablefor exercise. The older age of patients with heart failuremeans that there will be a high level of co-morbidity,which was not an issue in previous trials of highlyselected, atypical patients[8]. Poor recruitment to trials ofpatients with heart failure has been previously reported,with a high proportion declining to participate when con-tacted[44]. A trial of a nurse-intervention in primary carein the UK recruited 36% of those invited, compared with26% of eligible patients in our study. Reasons for non-par-ticipation given included a perception of being too old,Table 2: Reasons for non-non-eligibility and exclusions from BRUM-CHF from case-note assessment in patients on specialist Heart Failure nurse case-loadsReason for exclusion/ineligibility n %Not eligible 468 46.9Co-morbidity 204 20.4Physically unable 124Cognitive dysfunction 38Airways disease 23Visual disability 11Malignancy 8Cardiac related 153 15.3Recent stent 1Severe aortic stenosis/abdominal aortic aneurysm 10Unstable HF, arrhythmias, NYHA IV 81Implantable cardiac device 19Awaiting cardiac procedure: CABG/transplant/MVR 4Recent cardiac rehabilitation 1Recent myocardial infarction 1Recent cardiac transplant 1HOCM 1Postural hypotension 1Still being titrated on beta-blocker therapy 33Miscellaneous 91 9.1Risk assessment – unsuitable for home-visits 21Unable to read or write 3Not living in area 46Transport difficulties with attending hospital 8Not contactable 9Other 4Unable to speak English 77 7.7Unable to recruit before study end 4 0.4Total 997 100Page 7 of 9(page number not for citation purposes)
BMC Cardiovascular Disorders 2007, 7:9 http://www.biomedcentral.com/1471-2261/7/9too unwell or too busy[44]. This is an issue which willneed to be considered when planning rehabilitation serv-ices for patients with heart failure.The qualitative study is being undertaken in a patientgroup which has received specialist heart failure nursecare. Previous research has highlighted the low under-standing and knowledge about heart failure in patientswith this condition[41,45-50], but this research was priorto the introduction of specialist heart failure teams. Thisresearch will provide information about whether theinformation needs of patients with heart failure are beingmet by the new specialist heart failure nurse services.Competing interestsThe author(s) declare that they have no competing inter-ests.Authors' contributionsKJ wrote the initial protocol and designed this study.RCD, GYHL, MKD, JS, AJS, JWM and SJS participated inthe design of the study. RST wrote the statistical elementsof the original protocol and contributed to the design ofthe study. SMG designed and wrote the qualitative ele-ment of the initial protocol. JTI and KJ wrote the initialdraft of this paper. All authors read and approved the finalmanuscript.AcknowledgementsThis study is funded by the Department of Health's Policy Research Pro-gramme, as part of a joint DH/British Heart Foundation Heart Failure research initiative. The views and opinions expressed in this paper do not necessarily reflect those of the Department of Health.References1. Cowie M, Wood D, Coats A, Thompson S, Suresh V, Poole-WilsonP: Survival of patients with a new diagnosis of heart failure: apopulation based study. Heart 2000, 83:505-510.2. Croft J, Giles W, Pollard R, Keenan N, Caspar M, Anda R: Heart fail-ure survival among older adults in the United States: a poorprognosis for an emerging epidemic in the Medicare popula-tion. Arch Intern Med 1999, 159:505-510.3. 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