Studies: Telemonitoring benefits some CHF patients
Telemonitoring can benefit certain patients with congestive heart failure patients, according to two trials presented at the Heart Failure Association of the European Society of Cardiology’s Heart Failure Congress 2011, in Gothenburg, Sweden.
The overall results from the TIM-HF (Telemedicine to Improve Mortality in Heart Failure) and TEHAF (Tailored Telemonitoring in Patients with Heart Failure) studies showed no statistical benefit. However, recent meta-analyses (including one in the Cochrane Review) of the trials revealed that telemonitoring showed significant benefits in defined subgroups of patients, stated the European Society of Cardiology.
The results will be used to help in the design of future trials, according to the authors.
“The fact that we showed no benefit when two meta-analyses had previously demonstrated benefit suggested there could be problems with our study design and indicated the importance of undertaking further post hoc analyses,” stated TIM-HF's principal investigator Friedrich Koehler, MD, from Charité Universitätsmedizin in Berlin.
TIM-HF study
In the TIM-HF trial, Koehler and colleagues developed a telemonitoring platform that included mobile phone technology to enable the use of monitoring devices anywhere, the ability to transmit data within one minute and an easy-to-use system that could be operated by elderly patients.
The equipment kit included a portable ECG device, scales, blood pressure monitoring equipment and a pulse oximeter to measure oxygen saturation. The technology, which cost €16 million ($22.39 million U.S.) to develop, was funded by a public-private partnership between the German Federal Ministry of Economics & Technology and industry.
The system was designed to incorporate monitoring of co-morbidities such as diabetes, chronic obstructive pulmonary disease (COPD), anticoagulants and implantable cardiac device information. For emergency support, a mode for continuous ECG monitoring and oxygen saturation could be activated.
The TIM-HF trial took place between January 2008 and June 2010 at 165 participating sites, and included 710 stable patients with New York Heart Association (NYHA) Class II or III, left ventricular ejection fractions less than 35 percent and a history of HF decompensation. Patients were randomized to remote telemedical management (354 patients) or usual care (356 patients).
Results published in Circulation showed that at a median follow-up of 26 months, remote telemonitoring management delivered no significant benefits compared with usual care on all-cause mortality (P=0.87), or the composite endpoint of cardiovascular death and HF hospitalization (P=0.44).
The investigators conducted a second analysis to explore outcomes in pre-specified subgroups according to age, NYHA class, whether patients lived alone or not, median left ventricular ejection fractions, episodes of prior HF decompensation, the presence of implantable cardioverter defibrillators, uric acid levels, blood pressure, creatinine levels and scores from questionnaires that screened for depression (the PHQ-9 depression scores).
For patients with a prior history of decompensation, no depression on the PH-Q scale and who had left ventricular ejection fractions above 25 percent, cardiovascular death was statistically less likely to occur in the group randomized to telemedicine monitoring than those randomized to usual care (P<0.027), Koehler and colleagues reported. There was also a statistically significant benefit for the group randomized to telemedicine for the number of days lost due to hospitalization for heart failure and death.
The information forms the basis of a hypothesis which will be used to define the patient population in the TIM-HF II study, which is due to start enrollment in the fall, he stated.
TEHAF trial
In the TEHAF study, Josiane J.J. Boyne, RN, and colleagues from Maastricht University Medical Centre, in the Netherlands, conducted a multicenter randomized controlled trial to investigate the effectiveness of incorporating the Health Buddy system into telemonitoring. The system consists of an easy-to-use device with an LCD display that has four buttons which patients use to answer daily questions about heart-failure-related symptoms, knowledge of the condition and their behavior.
The concept is that patients’ responses can be automatically triaged into low, medium or high risk levels, enabling care providers to target high-risk patients and anticipate problems. No transfer of vital signs was used in the study, with the exception of patients providing information about weight, Boyne reported. To meet more specific patient needs around treatment or education, the investigators created four sets of dialogues that had variable emphasis on symptoms, knowledge and behavior.
The study was conducted in three Dutch centers and involved 382 patients with NYHA Class II to Class IV—197 were allocated to the intervention group and 185 to usual care.
Analysis after one year showed that 9.1 percent in the intervention group were admitted to a hospital for heart failure versus 13.5 percent in the usual-care group, a result that was not statistically significant.
However, the latest subgroup analysis of the primary endpoint, presented at the Heart Failure Congress, found that patients in the intervention group with heart failure durations of 18 months or less had a significant decrease in number of admissions for heart failure, (P=0.026). The subgroup analysis showed no such significant effects for patients who had heart failure duration of greater than 18 months.
Furthermore, for patients in the intervention group, a significant decrease was found in their face-to-face contact with heart failure nurses.
The results suggested that the Health Buddy system offers particular benefits for patients with heart failure duration of less than 18 months, the authors concluded. The system is based on the hypothesis that more knowledge leads to better compliance and therefore fewer symptoms, Boyne stated. Therefore, patients diagnosed recently may have greater potential to be influenced by the system than patients with longer histories of the condition who have already adapted their lifestyles.
Another possibility is that patients with longer duration of heart failure may prove harder to treat, she said.
The overall results from the TIM-HF (Telemedicine to Improve Mortality in Heart Failure) and TEHAF (Tailored Telemonitoring in Patients with Heart Failure) studies showed no statistical benefit. However, recent meta-analyses (including one in the Cochrane Review) of the trials revealed that telemonitoring showed significant benefits in defined subgroups of patients, stated the European Society of Cardiology.
The results will be used to help in the design of future trials, according to the authors.
“The fact that we showed no benefit when two meta-analyses had previously demonstrated benefit suggested there could be problems with our study design and indicated the importance of undertaking further post hoc analyses,” stated TIM-HF's principal investigator Friedrich Koehler, MD, from Charité Universitätsmedizin in Berlin.
TIM-HF study
In the TIM-HF trial, Koehler and colleagues developed a telemonitoring platform that included mobile phone technology to enable the use of monitoring devices anywhere, the ability to transmit data within one minute and an easy-to-use system that could be operated by elderly patients.
The equipment kit included a portable ECG device, scales, blood pressure monitoring equipment and a pulse oximeter to measure oxygen saturation. The technology, which cost €16 million ($22.39 million U.S.) to develop, was funded by a public-private partnership between the German Federal Ministry of Economics & Technology and industry.
The system was designed to incorporate monitoring of co-morbidities such as diabetes, chronic obstructive pulmonary disease (COPD), anticoagulants and implantable cardiac device information. For emergency support, a mode for continuous ECG monitoring and oxygen saturation could be activated.
The TIM-HF trial took place between January 2008 and June 2010 at 165 participating sites, and included 710 stable patients with New York Heart Association (NYHA) Class II or III, left ventricular ejection fractions less than 35 percent and a history of HF decompensation. Patients were randomized to remote telemedical management (354 patients) or usual care (356 patients).
Results published in Circulation showed that at a median follow-up of 26 months, remote telemonitoring management delivered no significant benefits compared with usual care on all-cause mortality (P=0.87), or the composite endpoint of cardiovascular death and HF hospitalization (P=0.44).
The investigators conducted a second analysis to explore outcomes in pre-specified subgroups according to age, NYHA class, whether patients lived alone or not, median left ventricular ejection fractions, episodes of prior HF decompensation, the presence of implantable cardioverter defibrillators, uric acid levels, blood pressure, creatinine levels and scores from questionnaires that screened for depression (the PHQ-9 depression scores).
For patients with a prior history of decompensation, no depression on the PH-Q scale and who had left ventricular ejection fractions above 25 percent, cardiovascular death was statistically less likely to occur in the group randomized to telemedicine monitoring than those randomized to usual care (P<0.027), Koehler and colleagues reported. There was also a statistically significant benefit for the group randomized to telemedicine for the number of days lost due to hospitalization for heart failure and death.
The information forms the basis of a hypothesis which will be used to define the patient population in the TIM-HF II study, which is due to start enrollment in the fall, he stated.
TEHAF trial
In the TEHAF study, Josiane J.J. Boyne, RN, and colleagues from Maastricht University Medical Centre, in the Netherlands, conducted a multicenter randomized controlled trial to investigate the effectiveness of incorporating the Health Buddy system into telemonitoring. The system consists of an easy-to-use device with an LCD display that has four buttons which patients use to answer daily questions about heart-failure-related symptoms, knowledge of the condition and their behavior.
The concept is that patients’ responses can be automatically triaged into low, medium or high risk levels, enabling care providers to target high-risk patients and anticipate problems. No transfer of vital signs was used in the study, with the exception of patients providing information about weight, Boyne reported. To meet more specific patient needs around treatment or education, the investigators created four sets of dialogues that had variable emphasis on symptoms, knowledge and behavior.
The study was conducted in three Dutch centers and involved 382 patients with NYHA Class II to Class IV—197 were allocated to the intervention group and 185 to usual care.
Analysis after one year showed that 9.1 percent in the intervention group were admitted to a hospital for heart failure versus 13.5 percent in the usual-care group, a result that was not statistically significant.
However, the latest subgroup analysis of the primary endpoint, presented at the Heart Failure Congress, found that patients in the intervention group with heart failure durations of 18 months or less had a significant decrease in number of admissions for heart failure, (P=0.026). The subgroup analysis showed no such significant effects for patients who had heart failure duration of greater than 18 months.
Furthermore, for patients in the intervention group, a significant decrease was found in their face-to-face contact with heart failure nurses.
The results suggested that the Health Buddy system offers particular benefits for patients with heart failure duration of less than 18 months, the authors concluded. The system is based on the hypothesis that more knowledge leads to better compliance and therefore fewer symptoms, Boyne stated. Therefore, patients diagnosed recently may have greater potential to be influenced by the system than patients with longer histories of the condition who have already adapted their lifestyles.
Another possibility is that patients with longer duration of heart failure may prove harder to treat, she said.