Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure

Abstract

IMPORTANCE Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of training at patients' homes might be an appealing alternative.OBJECTIVE To assess whether potential improvements in quality-of-life outcomes after a 9-week HCTR intervention in patients with heart failure translate into improvement in clinical outcomes during extended 12 to 24 months of follow-up, compared with usual care. DESIGN, SETTING, AND PARTICIPANTSThe Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial is a multicenter, prospective, open-label, parallel-group randomized clinical trial that enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less. Patients from 5 centers in Poland were randomized 1:1 to HCTR plus usual care or usual care only and followed up for 14 to 26 months after randomization.INTERVENTIONS During the first 9 weeks, patients underwent either an HCTR program (1 week in hospital and 8 weeks at home) or usual care with observation. The HCTR intervention encompassed telecare, telerehabilitation, and remote monitoring of implantable devices. No intervention occurred in the remaining study period. MAIN OUTCOMES AND MEASURESThe percentage of days alive and out of the hospital from randomization through the end of follow-up at 14 to 26 months.RESULTS A total of 850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5%]; mean [SD] age, 62.2 [10.2] years). The HCTR intervention did not extend the percentage of days alive and out of the hospital. The mean (SD) days were 91.9 (19.3) days in the HCTR group vs 92.8 (18.3) days in the usual-care group, with the probability that HCTR extends days alive and out of the hospital equal to 0.49 (95% CI, 0.46-0.53; P = .74) vs usual care. During follow-up, 54 patients died in the HCTR arm and 52 in the usual-care arm, with mortality rates at 26 months of 12.5% vs 12.4%, respectively (hazard ratio, 1.03 [95% CI, 0.70-1.51]). There were also no differences in hospitalization rates (hazard ratio, 0.94 [95% CI, 0.79-1.13]). The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, −0.31 to 0.30] mL/kg/min; P < .001) and quality of life (Medical Outcome Survey Short Form-36 questionnaire score, 1.58 [95% CI, 0.74-2.42] vs 0.00 [95% CI, −0.84 to 0.84]; P = .008), and it was well tolerated, with no serious adverse events during exercise. CONCLUSIONS AND RELEVANCEIn this trial, the positive effects of a 9-week program of HCTR in patients with heart failure did not lead to the increase in percentage of days alive and out of the hospital and did not red...

Quality of life in heart failure patients undergoing hybrid comprehensive telerehabilitation versus usual care – results of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial

“…No patient withdrew consent from the study or was lost during the 9-week intervention (HCTR group)/observation (UC group) period. Twenty-seven patients did not undergo telerehabilitation due to: technical difficulties with operating the telerehabilitation set (21), new onset of comorbidities (4), return to work (2) [23]. Eleven patients from the HCTR group and 4 patients from UC group did not agree to fill out the SF-36 questionnaire during the 9-week follow-up.…”

“…Initial psychological assessment and consultation, along with clinical evaluation, allowed Table I. TELEREH-HF inclusion and exclusion criteria [22,23]…”

“…Table II. TELEREH-HF methods -telerehabilitation set, telesupervised exercise training, education [22,23] Telerehabilitation set The EHO mini device was able to record ECG and transmit them via a mobile phone network to the monitoring center. An EHO mini device has training sessions preprogrammed for each patient (defined exercise duration, breaks, timing of ECG recording).…”

“…The planned training sessions were executed with the device indicating what needed to be done with sound (bleeps) and light signals (colors emitting diodes). The timing of automatic ECG recordings corresponded to peak exercise [22,23] Telesupervised exercise training Before beginning a training session, patients answer a series of questions regarding their present condition: fatigue, dyspnea, blood pressure, body mass, and medication taken. Patients then transmitted resting ECG data to the monitoring center.…”

“…Telephone contact was also used for psychological support [22,23] Education Patients were taught how to self-evaluate, how to measure HR, blood pressure, body mass, how to performed exercise training, how to evaluate the level of perceived exertion according to the Borg scale and how to operate a TR set. Education also encompassed smoking cessation, lipid management, nutritional counselling, vocational and psychosocial support [22,23] The number of phone calls and its length were discussed with the patient during initial psychological assessment and qualification for psychological counseling sessions Patients from the UC group received standard care appropriate for each center. Some of them could participate in a rehabilitation program which (apart from exercise training) encompassed psychosocial assessment focused on cardiovascular risk factors, psychological support, and counselling regarding adjustment to treatment and enhancing health-related QoL.…”