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Eur J Heart Fail. Mar 2009; 11(3): 312–318.
PMCID: PMC2645060

Home telemonitoring in heart failure patients: the HHH study (Home or Hospital in Heart Failure)

Abstract

Aims

The Home or Hospital in Heart failure (HHH) study was a European Community-funded, multinational, randomized controlled clinical trial, conducted in the UK, Poland, and Italy, to assess the feasibility of a new system of home telemonitoring (HT). The HT system was used to monitor clinical and physiological parameters, and its effectiveness (compared with usual care) in reducing cardiac events in heart failure (HF) patients was evaluated. Measurements were patient-managed.

Methods and results

From 2002 to 2004, 461 HF patients (age 60 ± 11 years, New York Heart Association class 2.4 ± 0.6, left ventricular ejection fraction 29 ± 7%) were enrolled at 11 centres and randomized (1:2) to either usual outpatient care or HT administered as three randomized strategies: (i) monthly telephone contact; (ii) strategy 1 plus weekly transmission of vital signs; and (iii) strategy 2 plus monthly 24 h recording of cardiorespiratory activity. Patients completed 81% of vital signs transmissions, as well as 92% of cardiorespiratory recordings. Over a 12-month follow-up, there was no significant effect of HT in reducing bed-days occupancy for HF or cardiac death plus HF hospitalization. Post hoc analysis revealed a heterogeneous effect of HT in the three countries with a trend towards a reduction of events in Italy.

Conclusion

Home or Hospital in Heart failure indicates that self-managed HT of clinical and physiological parameters is feasible in HF patients, with surprisingly high compliance. Whether HT contributes to a reduction of cardiac events requires further investigation.

Keywords: Home telemonitoring, Chronic heart failure, Prognosis, Sleep apnoea, Holter recording

Introduction

In western countries, ageing populations and escalation in healthcare costs for heart failure (HF) patients have increased the need for improved home care in place of expensive hospital admissions. Relatively simple solutions have proved to be effective.15 Recent improvements in technology, including the use of telephone support, now also allow more sophisticated continuous monitoring in the patient's home;68 however, the increased costs and the possible difficulties with patient acceptance of these novel approaches dictate that they should be rigorously evaluated.

At present, out of hospital monitoring in chronic HF patients—measuring vital signs such as heart rate, blood pressure, and symptoms—is usually performed by the primary care nurse or by a general practitioner. New telehealth technologies can provide long distance monitoring of clinical status, improving delivery of care, and quality of life in chronic HF patients.7,8 New physiological measures derived from heart rate and respiratory rhythms are now recognized as predictive factors in HF.911 Although specific interventions to target this problem are still under evaluation, home monitoring might prove cost-effective for HF management.

The multicentre randomized Home or Hospital in Heart Failure (HHH) study was designed to develop and evaluate a home telemonitoring (HT) system to supervise HF patients outside the hospital setting. Besides monitoring vital signs, the HHH study evaluated a new domiciliary system for long-term non-invasive cardiorespiratory and activity monitoring, in terms of clinical outcomes and patient acceptability. This system was designed for self-management, with the transmission of the acquired data through standard telephone lines to healthcare providers.

The HHH study was therefore structured as a multinational, multicentre telemonitoring network, combined with a randomized open controlled trial, involving 11 centres in three European countries (UK, Italy, and Poland).

The objectives were as follows: (i) to evaluate the feasibility of this system in patients with HF; (ii) to compare the efficacy of HT vs. usual care to reduce the cardiac events in HF patients at high risk of re-admission; (iii) to define the prevalence and the clinical relevance of home breathing disorders and abnormalities of heart rate variability. We focused on feasibility data and the clinical results of the trial.

Methods

Protocol

Eligible patients were first randomized to either usual outpatient care (control) or HT using a 1:2 allocation. Patients allocated to HT were then further randomized into following three groups of increasing complexity (Figure 1). The first group (strategy 1) received monthly supportive telephone contacts from a study nurse to check on their clinical status. The second group (strategy 2) received the same telephone support, but also transmitted their vital signs and other data (discussed subsequently), including details of changes in weight, blood pressure, and symptoms, weekly by telephone. Patients assigned to strategy 2 also performed monthly cardiorespiratory recordings; however, these data were transmitted for research purposes only and were not made available to the clinical team. The third group (strategy 3) carried out the same measurements as patients in strategy 2, but the monthly 24 h cardiorespiratory recordings were made available for clinical management (if required).

Figure 1
Flow diagram of the Home or Hospital in Heart failure (HHH) study. NICRAM, non-invasive cardiorespiratory and activity monitoring.

Inclusion and exclusion criteria

Inclusion criteria were (i) age >18 and <85 years; (ii) New York Heart Association (NYHA) classes II–IV; (iii) aetiology: ischaemic, idiopathic, hypertensive, or valvular; (iv) left ventricular ejection fraction ≤40%; (v) abnormal diastolic echocardiographic pattern (from E/A<1 to a more severe pattern); (vi) hospital admission for HF or decompensation in the previous 12 months; and (vii) optimized medical therapy.

Exclusion criteria were (i) myocardial infarction, revascularization or ICD implantation in the previous 6 months; (ii) angina or objective myocardial ischaemia requiring future revascularization; (iii) implanted ventricular or atrial pacemaker (except DDD pacemakers with good sinus activity); (iv) insulin-dependent diabetes or severe disease-limiting survival; (v) poor compliance with HT system; (vi) inclusion in another trial.

Randomization

The randomization list was generated by the coordinating centre in Montescano, Italy, with separate blocks held in each country. The individual patient allocation was to be revealed only after the patient identifiers (name, surname, and the date of birth) had been received at each national randomization centre.

Study outcomes

Primary endpoints were as follows: bed-days occupancy for HF in acute medical/surgical beds and composite endpoint of cardiac death and hospitalization due to HF. Secondary endpoints were: (i) bed-days occupancy for all cardiovascular reasons; (b) all-cause mortality; and (c) all-cause hospitalizations. All endpoints were adjudicated by an independent, blinded, Endpoint Committee.

Sample size calculation

We assumed that patients in the control arm would show a median bed-days occupancy of 20 bed-days/year (95% confidence interval: 11–73 bed-days/year) based on two admissions of 10 days each and that this would be reduced by 25% by HT. To detect this change with a two-sided type I error of 0.05 and a power of 85%, a sample size of at least 450 subjects, with subjects allocated in a ratio of 1:2 between usual clinical care and HT, respectively, was necessary. The calculations were performed after an arcsin(√{P}) normalizing transformation, where P is the proportion of bed-days in a year. The sample size was also adequate for testing the second primary endpoint of the study.

Study organization

The enrolment period was followed by a 12-month observation period. A clinical assessment, ECG, blood test, and echocardiogram were performed at baseline (+24 h cardiorespiratory recording) and at 12-months of follow-up.

Patients randomized to the control arm were informed about the study, but were not given all of the details of the HT system. After randomization, those patients allocated to the control arm were discharged as normal from the hospital. Patients enrolled in the HT arms were given educational support about how to use the HT devices, including the cardiorespiratory recorder and the modem, the digital blood pressure monitor (UA-767, A&D Company, Tokyo, Japan), and the electronic weighing scale. A detailed user manual, a diary, and study forms for measuring and transmitting vital signs were given to each patient. For patients enrolled in the outpatient clinic, the same procedures were followed.

Monitoring at home

The design of the telemonitoring system has been presented previously.12 The patients enrolled in HT strategies 2 and 3 transmitted weekly records of the following data to the coordinating centre via an automated interactive voice response (IVR) system: (i) weight; (ii) heart rate; (iii) systolic arterial pressure; (iv) dyspnoea score (1–10); (v) asthenia score (1–10); (vi) oedema score (1, feet swell in the morning; 2, in the evening; 3, always swollen); (vii) changes in therapy; and (viii) blood results.

Patients in HT strategies 2 and 3 were also given a portable device (a solid-state lightweight Holter-style recorder with built-in signal pre-processing, FM, Monza, Italy), which continuously recorded ECG, respiration, and physical activity over 24 h at home. The recorders (managed by the patients) automatically transmitted data by a telephone, through a dedicated modem (Appel Electronica srl, Torino, Italy), for analysis by the coordinating centre.

A 24 h answering machine allowed each patient to contact his/her reference hospital at any time and leave a message requesting help or advice (all HT groups).

As tested in a previous pilot study,13 each transmitted vital sign parameter was subjected to an automatic range check and to a stability check, based on the rate of change of each parameter over time. Any suspect data elicited a request for checking by the monitoring nurse or attending physician. No specific rules were given in the protocol for medical interventions when one of the specific parameters exceeded the pre-specified personalized normal range and the range of variation. Investigators (nurses or physicians) could choose the best action to re-establish the haemodynamic balance following modern guidelines.14

Education and technical support

Care and practice sessions were devoted to educating the patients in the use of the HT devices: the cardiorespiratory recorder and the modem, the digital blood pressure monitor (UA-767, A&D Company), and the electronic weighing scale. A detailed user manual, a diary, and study forms for measuring and transmitting vital signs were given to the patients.

Technical support for the enrolling centres and the national coordinating centres was provided by the coordinating centre (Montescano, Italy), using remote assistance with occasional onsite support. In Poland and the UK, first-level technical support was provided by the central signal analyst. Support for the IVR system was provided by the manufacturer (Appel Elettronica).

Statistical analysis

Comparisons of baseline clinical characteristics between different groups were carried out by one-way analysis of variance (continuous variables, normal distribution), Kruskal–Wallis test (continuous variables, non-normal distribution), or χ2 test (categorical variables).

Bed-days occupancy was computed as the proportion of hospitalization days during each patient's follow-up, multiplied by 365, and expressed as bed-days/year. The normalization allowed us to take into account possible differences in mortality, heart transplantation, and withdrawals from the study, between groups. Since a limited number of patients experienced an HF hospitalization during the follow-up, ordinary descriptive statistics (e.g. median and interquartile range) and related statistical tests were inadequate to summarize and compare bed-day occupancy among the different groups. Therefore, bed-days occupancy was categorized into three levels: 0 bed-days/year, below the median value, and equal or above the median value bed-days/year. The association between this variable and telemonitoring was assessed by logistic regression analysis (generalized logit).

We also analysed the number of hospitalizations in each patient, as this variable takes into account the whole burden—for the patient and for the healthcare system—of repeated hospitalizations. Also, this variable was categorized into three levels: zero, one, and two or more hospitalizations; its association with telemonitoring was assessed by logistic regression analysis.

Event-free survival curves were estimated by the Kaplan–Meier method and compared by the log-rank test. For the composite endpoint of cardiac death plus HF hospitalization, the time-to-event was set at the occurrence of death or at the first hospital admission (if any). The association between this endpoint and telemonitoring was assessed by logistic regression analysis.

A P-value less than 0.05 was considered statistically significant, and all tests were two-sided. Since two co-primary endpoints were analysed in the study, a correction for multiplicity was required. Therefore, we conservatively used a 0.025 significance level for each of them. All statistical analyses were carried out using the SAS/STAT statistical package, release 9.1.3 (SAS Institute Inc., Cary, NC, USA).

Results

Patients were recruited between July 2002 and July 2004. Recruitment was particularly difficult in the UK centres, as care strategies there aim to avoid hospital admission (a required study entry criterion). In the UK, care was largely based on the community with the general practitioner, with occasional follow-up visits to a hospital clinic where necessary. Overall, 617 eligible patients were identified; of these, 103 declined to participate and 50 were excluded for logistical reasons. Therefore, the final enrolment included 464 patients. Due to technical problems in the activation of telemonitoring devices at home, three enrolled patients could not participate in the study, leaving a final sample of 461 subjects: 215 from Italy, 187 from Poland, and 59 from the UK (Figure 1). Baseline clinical characteristics of the control patients and of those randomized to HT are reported in Table 1. Patients were predominantly men, with a mean age of around 60 years (older in the UK), with about one-third aged above 65. Treatment with angiotensin-converting enzyme-inhibitors, beta-blockers, and diuretics was given in 82–90% of the patients, indicating good medical therapy.

Table 1
Baseline clinical characteristics

The baseline characteristics (Table 2) of the treatment groups were well balanced in both Italy and the UK. However, in Poland, the telemonitored arm had significantly higher NYHA class, lower ejection fraction, higher left ventricular enddiastolic diameter, and worse dyspnoea score, compared with the usual care (control) patients.

Table 2
Baseline clinical characteristics according to country

Feasibility of the telemonitoring system

Patients completed 81% (75% in Poland, 82% in Italy, and 93% in the UK) of all practicable vital signs transmissions from home. Compliance was unrelated to NYHA class (P = 0.1) or older age (P = 0.25). A total of 439 voice messages were left on the 24 h answering machine—mainly for advice, but also for transmission of results or technical difficulties.

A baseline cardiorespiratory recording was performed in 443 patients (96%); 1630/2078 anticipated home cardiorespiratory recordings for strategies 2 and 3 and were actually practicable (technical problems, holidays, or other absences were the commonest cause for non-practicability). Overall, 92% of practicable recordings were carried by the patients (85% in Poland, 82% in Italy, and 99% in the UK), confirming high feasibility of a self-administered cardiorespiratory recording at home.

Telemonitoring and outcome

During a mean follow-up of 11.6 ± 2.7 months (the planned observational period was 12 months), 18 patients dropped out of the study and 33 died (30 from cardiac causes). During the follow-up period, 124 episodes of hospitalization for HF occurred in 81 patients—a single admission in 52 and two or more in 29. A further 34 hospitalizations were cardiac but not due to HF; 110 admissions were non-cardiac.

There was no significant effect of HT in reducing bed-days occupancy for HF, cardiac death plus HF hospitalization, or the number of re-hospitalizations (Table 3). None of the HT strategies was superior to the others in identifying patients at higher risk of events.

Table 3
Outcome measures

A post hoc analysis revealed a highly significant interaction between HT and country in the association with the number of HF hospitalizations (P = 0.041) and cardiac death+HF hospitalization (P = 0.004), indicating a heterogeneous effect of HT in the three countries. In Italy, when compared with Poland and the UK, a reduction in the number of multiple (two or more) HF hospitalizations was observed in the HT group (3 vs. 11%, P = 0.02). Moreover, the composite endpoint of cardiac death and HF hospitalization was more likely for usual-care patients (25%) than telemonitored patients (12%, P = 0.016) (Figure 2). In contrast, in Poland, we observed an opposite trend: both the number of multiple HF hospitalizations and the composite endpoint of cardiac death+HF hospitalization were increased in the HT group [9 vs. 3% (P = 0.13), and 35 vs. 24% (P = 0.12)].

Figure 2
Kaplan–Meier cumulative event-free rate, for the composite endpoint of cardiac death and heart failure hospitalization, in the whole population and in the Italian group.

Discussion

The HHH study has demonstrated that HT of vital signs and cardiorespiratory signals is feasible, with surprisingly high patient compliance, which was similar in the three countries with different healthcare systems. The technology was easy to use and was manageable by elderly patients without family support, whatever age or HF severity.

Disappointingly, in the overall HHH population, HT did not allow an early identification of clinical deterioration,or reduce hospitalization and mortality.

There are several possibilities for this unexpected result. First, the unexplained imbalance in baseline characteristics in the large Polish cohort was likely the cause for the unanticipated trend towards a better outcome in usual care patients observed in this country. Secondly, since the computation of the sample size was based on historical data, the study was underpowered in relation to the actual rates of events observed in the cohort of patients included in the study. As shown in Table 2, HHH patients were optimally treated according to current guidelines, which was not likely the case in the historical data used for sample size computation. Thirdly, the study centres were all highly experienced in HF management; therefore, the ‘usual care’ was possibly better than ‘usual’. Fourth, we used only intermittent monitoring of vital signs, as opposed to daily monitoring, as was used, for instance, in the TEN-HMS study.15 However, even this study failed to show a reduction in HF hospitalization, which suggests that weekly monitoring in HHH did not likely play a major role in the study results. Finally, we cannot exclude that actions taken by the different medical-nursing staff in response to HT alerts were in some instances not well-timed or effective. As already pointed out earlier, however, all enrolling centres were highly experienced in the management of HF, and practice was according to current guidelines.

When analysis was restricted to Italy (which had the largest enrolment and no imbalance in baseline characteristics between the treatment groups), HT showed a clear trend towards reducing the occurrence of multiple HF hospitalizations and the cumulative endpoint of cardiac death and HF hospitalization. The analysis per country, however, was not pre-specified at the beginning of the study and should be considered with caution as a post hoc analysis. The observed heterogeneous results in the different countries support the relevance of exploring the effects of HT in specific settings—as the clinical use of such techniques is potentially sensitive to local attitudes and patients' and physicians' behaviour—and also the need for larger sample sizes to avoid baseline imbalances such as those occurred in the Polish cohort of this study.

Recent meta-analyses of multidisciplinary strategies for the management of HF patients have shown that HT contributes to a better clinical outcome for cardiac death and hospitalizations.6,7 Most of these were single-centre studies, with different monitoring. Clark et al.7 in a new meta-analysis divided studies into those with only telephone support and those with monitoring of clinical parameters. Remote monitoring was more effective in reducing cardiac mortality than simple telephone contact (relative risk 0.62 vs. 0.85). In contrast, ‘HF hospitalization’ was significantly affected by structured telephone contact, particularly when integrated with effective multidisciplinary care. In the only multicentre study that tested remote monitoring of clinical parameters, death (but not hospitalization for HF) was significantly reduced.15

Conclusions

The HHH study has shown, in three different European countries, that long-term self-managed monitoring of clinical status and cardiorespiratory activity is surprisingly feasible at home, even in the elderly, using simple measurement devices, an automated IVR system, and data transmission via a standard telephone line. In addition to capturing unique clinical data, these new technologies may increase the patient's awareness of the disease and facilitate home care and management of chronic disease, and potentially, as observed in the Italian setting, reduce phases of clinical instability.

Funding

HHH was supported by E.C. grant (Action line 10.1 ‘Public Health, contract no. QLGA-CT-2001-02424).

Acknowledgements

We are grateful to all investigators (physicians, nurses, and technicians) who have enthusiastically worked in the HHH study. We also thank M. Sanarico for his support in the statistical analyses.

Conflict of interest: none declared.

Appendix

Steering Committee: P.S. (Chairman), A.M., G.D.P., P.J., M.T.L.R., P.P., L.T.; Scientific Board: P.S., L.T., H. Dargie; Medical Committee: A.M. (Chairman), S.C., J. Dwight, M. Emdin, A. Di Lenarda, C. Campana, P.P., R. Gill, R. Szelemej, M. Barlow; Technical Committee: G.D.P. (Chairman), R.M., D. Andrews, T. Witowski; Writing Committee: P.S., G.D.P., A.M., P.P., P.J.; Event Committee: C. Opasich (Chairman), G. Specchia, G. Rackzak; Enrolling Centres: University of Oxford, TMR and Department of Cardiovascular Medicine, John Radcliffe Hospital Oxford, UK (P.S., P.J., D. Andrews, J. Dwight); Fondazione S Maugeri Clinica del Lavoro e della Riabilitazione, Montescano, Italy (G.D.P., S.C., M.T.L.R., R.M.); Istituto di Fisiologia Clinica, CNR, Pisa, Italy (M. Emdin, C. Passino); Policlinico di Monza, Monza, Italy (A.M., C. Bersano); Azienda ‘Ospedialiera Riuniti’, Trieste, Italy (A. Di Lenarda, L. Vitali Serdoz); IRCCS Policlinico San Matteo, Pavia, Italy (L.T., C. Campana); Clinical Military Hospital, Wroclaw, Poland (P.P., K. Nowak, T. Witowski); Central Hospital of Ministry Affairs and Administration, Warsaw, Poland (R. Gill, A. Pawlak); Dr A. Sokolowski Hospital. Walbryzch, Poland (R. Szelemej, A. Jurczyk); University of Glasgow, Glasgow, UK (H. Dargie, M. Barlow); Romford Cardiovascular Research, Romford, UK.

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