Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial.

AIMS: Remote patient management (RPM) in heart failure (HF) patients has beneficial clinical effects. This analysis investigates the effects of RPM used in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial on HF-specific self-care. METHODS AND RESULTS: From 2013 to 2017, 1538 HF outpatients (age 70.3 ± 10.5 years, 70% men, 52%/47% NYHA II/III, 65% LVEF ≤45%) with a recent HF hospitalization were included to the study and randomized to usual care (UC) plus RPM (n = 796) or UC only (n = 775), with a 12-month follow-up. Self-reported self-care behaviour at baseline and at end of study was assessed with the 9-item European Heart Failure Self-care Behaviour Scale (EHFScBS-9), obtaining 1321 patients with valid baseline and follow-up questionnaires for the analysis. EHFScBS-9 sum scores increased in the RPM group (n = 667) from 78.7 ± 17 to 84.5 ± 14 and in the UC group (n = 654) from 79.0 ± 17 to 80.0 ± 16 from baseline to 12 months [difference in means (MD) 4.58 (3.02, 6.14); P < 0.001] with highest improvement [8.66 (3.52; 13.81)] in patients living alone and having an inadequate (<70) baseline EHFScBS-9. There were differences between both groups in item 'I weight myself every day' [MD -1.13 (-1.24, -1.02); P < 0.001] and item 'I take my medication as prescribed' [MD -0.06 (-0.10, -0.01); P = 0.014]. No correlation was found between the EHFScBS-9 score and the efficacy of RPM on the TIM-HF2 primary endpoint of percentage of days lost due to unplanned cardiovascular hospitalization or death of any cause. CONCLUSIONS: RPM improves HF-specific self-care behaviour by achieving a better adherence to recommended HF regimen. REGISTRATION: ClinicalTrials.gov: NCT01878630.

Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial.

AIMS: Remote patient management (RPM) enables early detection and prevention of deterioration in heart failure (HF) patients by measuring vital parameters. The analysis objective is to assess patient reported experience with RPM, adherence to daily measurements, and outline affecting factors both. METHODS AND RESULTS: Telemedical interventional management in-HF2 was conducted in 2013-18 with 1 538 HF patients with a 12-month follow-up. Under guidance of HF nurses, patients had to measure daily weight, blood pressure, electrocardiogram, and self-rated health status. At the end of the study, patients received a programme survey to analyse patient perceptions and satisfaction with telemedicine care and study organization. Adherence was distinguished between measurement of at least one [incomplete adherence (IA)] and all vital parameters [complete adherence (CA)] and defined as ratio of the number of days of measurements taken divided by the number of days of possible measurements. All data and group differences were analysed descriptively (mean ± SD) and by analysis of variance and t-test. Survey response rate was 79.7%. Patients were satisfied with the programme and device usability. CA was 89.1 ± 14.1%, consistently high over the study course and independent of severity of disease (left ventricular ejection fraction, N terminals pro brain natriuretic peptide, New York Heart Association). Lower IA was found with patients <70 years and prior to unplanned cardiovascular (CV) hospitalizations (difference by -5.2 ± 20.5%) and after unplanned CV hospitalizations compared with the entire study period (lower by -12.8 ± 24.7%). Patients from rural areas were found to have higher CA than patients from urban regions. CONCLUSIONS: With user-friendly devices, pre-interventional patient training, regular patient contact and close cooperation between primary physicians and telemedical centre, a long-lasting high adherence and satisfaction could be achieved. A change in adherence might detect health deterioration and indicate the need to intensify RPM. REGISTRATION: ClinicalTrials.gov (NCT01878630) and Deutsches Register Klinischer Studien (DRKS00010239).

Telemonitoring in patients with chronic heart failure and moderate depressed symptoms: results of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) study.

AIMS: Depression is a frequent comorbidity in patients with chronic heart failure (CHF). Telemonitoring has emerged as a novel option in CHF care. However, patients with depression have been excluded in most telemedicine studies. This pre-specified subgroup analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial investigates the effect of telemonitoring on depressive symptoms over a period of 12 months. METHODS AND RESULTS: The TIM-HF study randomly assigned 710 patients with CHF to either usual care (UC) or a telemedical intervention (TM) using non-invasive devices for daily monitoring electrocardiogram, blood pressure and body weight. Depression was evaluated by the 9-item Patient Health Questionnaire (PHQ-9) with scores ≥10 defining clinically relevant depressive symptoms. Mixed model repeated measures were performed to calculate changes in PHQ-9 score. Quality of life was measured by the Short Form-36. At baseline, 156 patients had a PHQ-9 score ≥10 points (TM: 79, UC: 77) with a mean of 13.2 points indicating moderate depressiveness. Patients randomized to telemedicine showed an improvement of their PHQ-9 scores, whereas UC patients remained constant (P = 0.004). Quality of life parameters were improved in the TM group compared to UC. Adjustment was performed for follow-up, New York Heart Association class, medication, age, current living status, number of hospitalizations within the last 12 months and serum creatinine. In the study population without depression, the PHQ-9 score was similar at baseline and follow-up. CONCLUSION: Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.

Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial.

BACKGROUND: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention. METHODS: TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01878630. FINDINGS: Between Aug 13, 2013, and May 12, 2017, 1538 patients were enrolled (765 to the remote patient management group and 773 to the usual care group) in the main trial. 671 of 765 patients in the remote patient management group and 673 of 773 in the usual care group completed the main trial and started the extended follow-up period up to 1 year later. In the extended follow-up period, the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality did not differ significantly between groups weighted mean 5·95% [95% CI 4·59-7·31] in the RPM group vs 6·64% [95% CI 5·19-8·08] in the usual care group [rate ratio 0·79; 95% CI 0·78-1·21]). However, when data from the main trial and the extended follow-up period were combined, the percentage of days lost due to unplanned cardiovascular hospitalisation or all-cause death was significantly less in patients allocated to the RPM group (382 [50%] of 765; weighted mean 9·28%; 95% CI 7·76-10·81) than in the UC group (398 [51%] of 773; 11·78%; 95% CI 10·08-13·49; ratio of weighted average 0·79; 95% CI 0·62-1·00; p=0·0486). INTERPRETATION: The positive effect of our RPM intervention on morbidity and mortality over the course of the main trial was no longer observed 1 year after stopping the RPM intervention. However, because the TIM-HF2 trial was not powered to show significance during the extended follow-up period, our results are exploratory and require further research. FUNDING: German Federal Ministry of Education and Research.

Non-invasive telemedical care in heart failure patients and stroke: post hoc analysis of TIM-HF and TIM-HF2 trials.

AIMS: Patients with chronic heart failure (CHF) have an increased risk of ischaemic stroke. We aimed to identify the incidence rate and factors associated with ischaemic stroke or transient ischaemic attack (TIA) in CHF patients as well as the impact of non-invasive telemedical care (NITC) on acute stroke/TIA. METHODS AND RESULTS: We retrospectively analysed baseline characteristics of 2248 CHF patients enrolled to the prospective multicentre Telemedical Interventional Monitoring in Heart Failure study (TIM-HF) and Telemedical Interventional Management in Heart Failure II study (TIM-HF2), randomizing New York Heart Association (NYHA) II/III patients 1:1 to NITC or standard of care. Hospitalizations due to acute ischaemic stroke or TIA during a follow-up of 12 months were analysed. Old age, hyperlipidaemia, lower body mass index, and peripheral arterial occlusive disease (PAOD) were independently associated with present cerebrovascular disease on enrolment. The stroke/TIA rate was 1.5 per 100 patients-years within 12 months after randomization (n = 32, 1.4%). Rate of stroke/TIA within 12 months was in the intervention group similar compared with the control group (50.0% vs. 49.8%; P = 0.98) despite that the rate of newly detected atrial fibrillation (AF) was higher in the intervention group (14.1% vs. 1.6%; P < 0.001). A history of PAOD (OR 2.7, 95% CI 1.2-6.2; P = 0.02) and the highest tertile (OR 3.0, 95% CI 1.1-8.3) of N-terminal pro-brain natriuretic peptide (NT-proBNP) on enrolment were associated with stroke/TIA during follow-up. In patients who suffered acute stroke or TIA during follow-up, echocardiography was part of the diagnostic workup in only 56% after hospital admission. CONCLUSIONS: Annual rate of ischaemic stroke/TIA in NYHA II/III patients is low but higher in those with elevated NT-proBNP levels and history of PAOD at baseline. NITC showed no impact on the stroke rate during 1 year follow-up despite a significantly higher rate of newly detected AF. Irrespective of known CHF, echocardiography was often missing during in-hospital diagnostic workup after acute stroke/TIA.

Telemedical Interventional Management in Heart Failure II (TIM-HF2), a randomised, controlled trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description of the intervention.

BACKGROUND: Heart failure (HF) is a complex, chronic condition that is associated with debilitating symptoms, all of which necessitate close follow-up by health care providers. Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF. Remote patient management (RPM) in this patient population may help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation. OBJECTIVE: The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. METHODS: The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only and are followed for 12 months. The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all-cause death. The main secondary outcomes are all-cause and cardiovascular mortality. CONCLUSION: The TIM-HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01878630.

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.

BACKGROUND: Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population. METHODS: The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed. FINDINGS: Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55-5·23) in the remote patient management group and 6·64% (6·19-7·13) in the usual care group (ratio 0·80, 95% CI 0·65-1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14-10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21-13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50-0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560). INTERPRETATION: The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality. FUNDING: German Federal Ministry of Education and Research.

Prognostic value of serial six-minute walk tests using tele-accelerometry in patients with chronic heart failure: A pre-specified sub-study of the TIM-HF-Trial.

BACKGROUND: The six-minute walk test (6MWT) is an established functional test assessing exercise capacity and is used to predict clinical prognosis in patients with chronic heart failure (HF). Tele-accelerometry is a novel approach to activity monitoring using telemedical data transfer and allows a Tele-6MWT to be performed in an outpatient setting. It offers patients the option of performing simple serial follow-up tests in their own home. AIMS: The aim of this study was to investigate the prognostic value of serial Tele-6MWTs using tele-accelerometry in patients with HF. DESIGN/METHODS: In this proof-of-concept study, 155 patients with HF completed the Tele-6MWT in an outdoor setting once per month over a period of 0.25-21 months. We analysed the differences in the number of steps over time to predict hospitalization as a result of HF or death. RESULTS: Patients with at least one event (n = 31) recorded a lower number of steps and a shorter distance in Tele-6MWT at baseline compared with patients who remained event-free (n = 124) (540.1 ± 78.4 steps vs. 601.8 ± 76.7 steps, P < 0.001 respectively; 353.2 ± 82.4 m vs. 418.8 ± 95.6 m, P < 0.001). Patients (n = 19) who performed more than one Tele-6MWT prior to a clinical event showed no significant difference in the number of steps, regardless of whether the baseline test was compared with the last Tele-6MWT before the event or with the last two tests before the event. CONCLUSION: Tele-6MWT has a high predictive value with respect to hospitalization as a result of HF or death from any cause and the results were comparable with the prognostic impact of a conventional 6MWT. Therefore Tele-6MWT may be used as alternative test method in the home environment. However, there is no added prognostic value of repeating Tele-6MWTs on a monthly basis.

Tele-accelerometry as a novel technique for assessing functional status in patients with heart failure: feasibility, reliability and patient safety.

BACKGROUND: The six-minute walk test (6MWT) is an established measure of functional exercise capacity associated with clinical prognosis in Chronic Heart Failure (CHF). The aim of this study is to evaluate the employment of tele-accelerometry for the remote assessment of 6MWT in CHF. METHODS: 155 patients were subjected to tele-accelerometry in form of monthly 6MWTs in their home surroundings. Accelerometer output included steps/6 min and walking speed. Data was directly transferred via mobile network to the Telemedicine Centre subsequent to test completion. 6MWT distance was measured by hand wheel and steps were counted with a digital hand-counter at baseline (Test 1) and at 12 months follow-up (Test 2). RESULTS: Accelerometer accuracy was within the 99th percentile. There was a significant correlation between step count, walking speed and measured 6MWT distance (Test 1: steps: r=0.80, P<0.001; Test 2: steps: r=0.90, P<0.001 and Walking Speed Test 1: r=0.80, P<0.001; Walking Speed Test 2: r=0.86, P<0.001). The reproducibility of tele-accelerometry was within 95% margin for all performance parameters, which showed stronger associations to quality of life questionnaire (Short Form - 36) Physical Component Score (PCS) than New York Heart Association (NYHA) functional class. CONCLUSION: Tele-accelerometry is feasible in patients with CHF and output parameters are indicative of exercise capacity. The benefit of this approach lies in its simplicity under every day circumstances by enabling routine performance testing to assess patients' functional status.

Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial.

BACKGROUND: The randomized Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial (NCT00543881) was performed during 2008 and 2010 to determine whether physician-led remote patient management (RPM) compared with usual care would result in reduced mortality and morbidity in stable out-patient heart failure (HF) patients. However, besides results of clinical benefit, the acceptance by patients and primary physicians is necessary for the implementation of RPM as part of the upcoming out-patient HF-care programs. METHODS: Two months after finishing of the trial, a survey based analysis of the perception of telemedical care with patients (n=288) and primary physicians (n=102) was carried out. The survey included questions regarding self-management, usability and physician-patient communication. RESULTS: The concept of RPM was perceived positively by patients and physicians. The devices were assessed as easy to use (98.6%, n=224) and robust (88.8%, n=202). Through trial participation and daily measurements most of the patients (85.5%, n=195) felt more confident in dealing with their disease than before. The perception of the nurses and physicians of the telemedical centers was professional (92.1%, n=210 and 89.9%, n=205) and committed (94.3%, n=215 and 91.7%, n=209). Also more than half of the patients noticed an improvement in the contact with their primary physician (52.6%, n=120); and for 46.1% (n=105) the contact has not been changed. CONCLUSIONS: RPM will be a medical care concept for recently hospitalized HF- patients in the near future but the optimal telemedical setting of RPM and the duration of this intervention have to be defined in further clinical trials.