Definition of a Method for the Evaluation of Telemedicine Platforms in the Italian Context.

Background: The COVID-19 outbreak led to the diffusion of several telemedicine solutions. The choice of the correct platform is crucial for ensuring the release of effective assistance. However, there is a lack of an objective method for the assessment of technical features. Objective: This study proposes a methodology for the evaluation of functional requirements of telemedicine platforms. This approach also permits the comparison of solutions in the Italian market by means of defined parameters, thus directing the choice of health care professionals. Methods: The study is divided into three phases. First, a mapping of the telemedicine platforms operating in Italy is performed. Then, the available platforms are selected based on the offered telemedicine activity. Finally, a method for evaluating the investigated platforms is defined. Results: Thirty-three (n = 33) technological systems were identified through an accurate investigation on the web and interviews with IT companies. Fifteen parameters were defined and organized into three categories: (1) usability of the telemedicine platform, (2) security, and (3) technological and organizational aspects. A score between 1 and 4 was assigned to each parameter, proportionally to the completeness of the platform. In particular, 62.96% of platforms reached an average score between 3.01 and 4 points; 33.33% of them had scores between 2.01 and 3, while the remaining 3.70% of solutions obtained a result between 1.01 and 2. Conclusions: The study provides an evaluation approach that is easily usable by health professionals to select the most suitable platform. The number of solutions and quality of information could be updated to obtain a complete tool.

Characteristics, Outcomes, and Long-Term Survival of Patients With Heart Failure Undergoing Inpatient Cardiac Rehabilitation.

OBJECTIVE: To investigate the association of cardiac rehabilitation (CR) participation with all-cause mortality after a hospitalization for heart failure (HF) and to describe the characteristics and functional and clinical outcomes of HF patients undergoing inpatient CR. DESIGN: Multicenter cohort study. The association between CR participation and all-cause mortality from discharge from the acute care setting was assessed using Cox regression analysis adjusting for established prognostic factors. SETTING: Six inpatient rehabilitation facilities. PARTICIPANTS: A total of 3219 patients with HF admitted to inpatient CR between January 2013 and December 2016. Of these patients, 1455 had been transferred directly from acute care hospitals after a hospitalization for HF (CR-group 1) and 1764 had been admitted from the community due to worsening functional disability or worsening clinical conditions (CR-group 2). Serving as a control group were 633 patients not referred to CR after a hospitalization for HF served as control group (non-CR group). INTERVENTIONS: Cardiac rehabilitation. MAIN OUTCOME MEASURES: Long-term mortality. Secondary outcomes were: (1) change in functional capacity, as assessed by change in 6-minute walking distance from admission to discharge; (2) clinical outcomes of the index inpatient rehabilitation admission, including in-hospital mortality and unplanned readmission to the acute care. RESULTS: Compared with the non-CR group, the adjusted hazard ratios of mortality at 1, 3, and 5 years for CR-group 1 patients were 0.82 (range, 0.68-0.97), 0.81 (range, 0.71-0.93), and 0.80 (range, 0.70-0.91). The 6-minute walking distance increased from 230-292 meters (P<.001), and 43.4% of the patients gained >50 m improvement. Overall, 2.5% of the patients died in hospital and 4.7% of the patients experienced unplanned readmissions to acute care, with significant differences between group 1 and group 2. CONCLUSIONS: Our data show that inpatient CR is effective in improving functional capacity and suggest that inpatient CR provided in the earliest period after a hospitalization for HF is associated with long-term improved survival.

Telehealth and Telecare: A Real-Life Integrated Experience in the COVID-19 Pandemic.

Background:In the first few months of 2020, Lombardy was the hardest-hit region in Italy for COVID-19 cases. Our Rehabilitation Institute offered a telemedicine service to COVID-19 patients discharged after hospitalization.Methods:Patients transferred from Emergency, Intensive Care, and Pulmonology departments of the principal regional hospital hubs had an average stay in our hospital of 2-3 weeks. On discharge, at home, they underwent a telecare nursing and specialist teleconsultation program for 3 months, including monitoring of vital signs and symptoms. Patients completed the SF-12 questionnaire at the start and end of the program and rated their satisfaction with it.Results:The program involved 130 patients (51%). During the period, there were 14 ± 2 (1,800 in total) telenursing support phone calls per patient made, and 12.5 ± 3.4 oxygen saturation readings per patient (1,631 in total). Persisting symptoms, frequently in combination, were present at the start of the program in 124 (94%) patients. There was a significant reduction of symptoms (p < 0.0000) after the telecare program. The physical component of SF-12 significantly improved at the end [Δ(t1-t0) = 6.7 ± 9.3, p < 0.0001]. On the contrary, the mental component of SF-12 remained unchanged or decreased slightly in patients ≤70 years of age [Δ(t1-t0) = -2.7 ± 12.3, ns], while it decreased significantly [Δ(t1-t0) = -5.4 ± 12.4, p = 0.0367] in older patients (although remaining mild). Patient satisfaction with the program was very high in all 130 patients.Conclusions:Our Telehealth and Telecare Service offers an example of rapid scaling and adaptation of an existing program to meet the needs of COVID-19 patients. Our findings indicate that telemedicine can be an integral part of clinical practice if supported by the institution with training and IT support provided to patients, nurses, and clinicians.

Patients recovering from COVID-19 pneumonia in sub-acute care exhibit severe frailty: Role of the nurse assessment.

AIMS AND OBJECTIVES: To document the level of frailty in sub-acute COVID-19 patients recovering from acute respiratory failure and investigate the associations between frailty, assessed by the nurse using the Blaylock Risk Assessment Screening Score (BRASS), and clinical and functional patient characteristics during hospitalisation. BACKGROUND: Frailty is a major problem in patients discharged from acute care, but no data are available on the frailty risk in survivors of COVID-19 infection. DESIGN: A descriptive cross-sectional study (STROBE checklist). METHODS: At admission to sub-acute care in 2020, 236 COVID-19 patients (median age 77 years - interquartile range 68-83) were administered BRASS and classified into 3 levels of frailty risk. The Short Physical Performance Battery (SPPB) was also administered to measure physical function and disability. Differences between BRASS levels and associations between BRASS index and clinical parameters were analysed. RESULTS: The median BRASS index was 14.0 (interquartile range 9.0-20.0) denoting intermediate frailty (32.2%, 41.1%, 26.7% of patients exhibited low, intermediate and high frailty, respectively). Significant differences emerged between the BRASS frailty classes regards to sex, comorbidities, history of cognitive deficits, previous mechanical ventilation support and SPPB score. Patients with no comorbidities (14%) exhibited low frailty (BRASS: median 5.5, interquartile range 3.0-12.0). Age ≥65 years, presence of comorbidities, cognitive deficit and SPPB % predicted <50% were significant predictors of high frailty. CONCLUSIONS: Most COVID-19 survivors exhibit substantial frailty and require continuing care after discharge from acute care. RELEVANCE TO CLINICAL PRACTICE: The BRASS index is a valuable tool for nurses to identify those patients most at risk of frailty, who require a programme of rehabilitation and community reintegration.

Recovering of oxygenation, physical function and disability in patients with Covid-19.

The present case report describes middle-time course of respiratory and physical variables in eight Covid-19 patients who were transferred from ICU of Covid Hub in our subacute Covid-19 unit. Secondly they were admitted in a pulmonary rehabilitation unit and, at discharge, a tele-rehabilitation program was provided as a continuum of care at home. Time course of oxygenation, physical function and disability were recorded. As expected, the acute event produced in these patients a dramatic worsening in oxygenation and physical activities, with a substantial improvement in oxygenation and mild disability after the sub-acute stay. After rehabilitation program, the patients showed additional improvement in particular in physical function. Anyway, this recover was not complete for all patients. The majority of Covid-19 survivors experienced ARF recovered oxygenation, physical function and disability within a median time of 137 days. A minority needs further follow up and rehabilitation maintenance due to incomplete recovery.

How the COVID-19 infection tsunami revolutionized the work of respiratory physiotherapists: an experience from Northern Italy.

Due to COVID-19 outbreak, to lighten the burden of acute and critical care hospitals, some respiratory rehabilitation departments have been used to host patients with COVID-19 in the post-acute phase. This new and unexpected situation required a change of roles and scheduling of the rehabilitation teams. In this manuscript we describe the unexpected and urgent organizational change of the Cardio-Pulmonary Rehabilitation (CPR) service during the COVID-19 emergency in a Northern Italian rehabilitation hospital, focusing on the Respiratory Physiotherapists' (RPTs) role. A quick three-days complete reorganization of the entire hospital was needed. A COVID-19 care team including a multidisciplinary panel of physicians, nurses, and RPTs was quickly performed to manage 90 beds for post acute patients with COVID-19. Within the team, the RPTs changed their shifts, so as to be available 16h per day, 7 days out of 7. Remodelled tasks in charge of RPTs were: oxygen therapy daily monitoring, non invasive ventilation (NIV) and continuous positive airways pressure (CPAP) delivery, pronation and postural changes to improve oxygenation, reconditioning with leg/arm cranking and exercises, initial and final patients' functional assessment by short-physical performance battery (SPPB) and 1-minute sit-to-stand test (1-STS) to evaluate motor conditions and exercise-induced oxygen desaturation. Three "what-to-do" algorithms were developed to guide: i) oxygen de-escalation by reducing inhaled fraction of oxygen (FiO2); ii) oxygenation improvement through the use of Venturi mask; iii) reconditioning and physical activity. One-hundred seventy patients were treated in one month. As main topics, RPTs have been involved in oxygen therapy management in almost a third of the admitted patients, reconditioning exercises in 60% of the cases, and initial and final functional motor capacity assessment in all patients. Details of activities performed by the RPT in one typical working day are also shown. Our reorganization has exploited the professional skills and clinical expertise of the RPTs. This re-organization can provide practical insights to other facilities that are facing this crisis, and may be a starting point for implementing post-COVID-19 rehabilitation. Future studies will have to improve and review this organization.

Home-based telerehabilitation in older patients with chronic obstructive pulmonary disease and heart failure: a randomised controlled trial.

Background: chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist in older people, reducing patients' quality of life (QoL) and increasing morbidity and mortality. Objective: we studied the feasibility and efficacy of an integrated telerehabilitation home-based programme (Telereab-HBP), 4 months long, in patients with combined COPD and CHF. The primary outcome was exercise tolerance evaluated at the 6-min walk test (6MWT). Secondary outcomes were time-to-event (hospitalisation and death), dyspnoea (MRC), physical activity profile (PASE), disability (Barthel) and QoL (MLHFQ and CAT). Study design: randomised, open, controlled, multicenter trial. Methods: the Telereab-HBP included remote monitoring of cardiorespiratory parameters, weekly phone-calls by the nurse, and exercise programme, monitored weekly by the physiotherapist. All outcomes were studied again after 2 months of a no-intervention period. Results: in total, 112 patients were randomised, 56 per group. Their mean (SD) age was 70 (9) years, and 92 (82.1%) were male. After 4 months, the IG were able to walk further than at baseline: mean (95% CI) Δ6MWT was 60 (22.2,97.8) m; the CG showed no significant improvement: -15 (-40.3,9.8) m; P = 0.0040 between groups. In IG, the media time to hospitalisation/death was 113.4 days compared with 104.7 in the CG (P = 0.0484, log-rank test). Other secondary outcomes: MRC (P = 0.0500), PASE (P = 0.0015), Barthel (P = 0.0006), MLHFQ (P = 0.0007) and CAT (P = 0.0000) were significantly improved in the IG compared with the CG at 4 months. IG maintained the benefits acquired at 6 months for outcomes. Conclusions: this 4-month Telereab-HBP was feasible and effective in older patients with combined COPD and CHF.

Skeletal Muscle Myopathy in Heart Failure: the Role of Ejection Fraction.

PURPOSE OF REVIEW: This review summarizes: (1) the structural and functional features coupled with pathophysiological factors responsible of skeletal muscle myopathy (SMM) in both heart failure with reduced (HFrEF) and preserved (HFpEF) ejection fraction and (2) the role of exercise as treatment of SMM in these HF-related phenotypes. RECENT FINDINGS: The recent literature showed two main phenotypes of heart failure (HF): (1) HFrEF primarily due to a systolic dysfunction of the left ventricle and (2) HFpEF, mainly related to a diastolic dysfunction. Exercise intolerance is one of most disabling symptoms of HF and it is shown that persists after the normalization of the central hemodynamic impairments by therapy and/or cardiac surgery including heart transplant. A specific skeletal muscle myopathy (SMM) has been defined as one of the main causes of exercise intolerance in HF. The SMM has been well described in the last 20 years in the HFrEF; on the contrary, few studies are available in HFpEF. Recent evidences have revealed that exercise training counteracts HF-related SMM and in turn ameliorates exercise intolerance.

Cardiac Prevention and Rehabilitation "3.0": From acute to chronic phase. Position Paper of the ltalian Association for Cardiovascular Prevention and Rehabilitation (GICR-IACPR).

Cardiac rehabilitation (CR) is the subspecialty of clinical cardiology dedicated to the treatment of cardiac patients, early and in the long term after an acute event. The aim of CR is to improve both quality of life and prognosis through prognostic stratification, clinical stabilization and optimization of therapy (pharmacological and non), management of comorbidities, treatment of disability, as well as through the provision and reinforcement of secondary prevention interventions and maintenaince of adherence to treatment. The mission of CR has changed over time. Once centered on the acute phase, aimed primarily at short-term survival, the healthcare of cardiac patients now increasingly involves the chronic phase where the challenge is to guarantee continuity and quality of care in the medium and long-term. The aim of the present position paper is to provide the state-of-the-art of CR in Italy, discussing its trengths and weaknesses as well as future perspectives.

Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study.

OBJECTIVE: The purpose of the study was to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in sub-acute hemiplegic patients. DESIGN: Randomized controlled pilot study. SETTING: Inpatient rehabilitation centers. PARTICIPANTS: Thirty hemiplegic stroke patients (Ashworth spasticity index <3) were recruited and randomly divided into a Treatment group (TG) and Control group (CG). INTERVENTIONS: Patients in the TG received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the CG received the same amount of time in terms of conventional hand rehabilitation. MAIN OUTCOME MEASURES: Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences, (Δ) mean(standard deviation), compared between groups. Results Twenty-seven patients concluded the program: 14 in the TG and 13 in the CG. None of the patients refused the device and only one adverse event of rheumatoid arthritis reactivation was reported. Baseline data did not differ significantly between the two groups. In TG, ΔMI 23(16.4), ΔNHPT 0.16(0.16), ΔGRIP 0.27(0.23) and ΔPINCH 0.07(0.07) were significantly greater than in CG, ΔMI 5.2(9.2), ΔNHPT 0.02(0.07), ΔGRIP 0.03(0.06) and ΔPINCH 0.02(0.03)] ( p=0.002, p=0.009, p=0.003 and p=0.038, respectively). CONCLUSIONS: Gloreha Professional is feasible and effective in recovering fine manual dexterity and strength and reducing arm disability in sub-acute hemiplegic patients.

The future of telemedicine for the management of heart failure patients: a Consensus Document of the Italian Association of Hospital Cardiologists (A.N.M.C.O), the Italian Society of Cardiology (S.I.C.) and the Italian Society for Telemedicine and eHealth (Digital S.I.T.).

Telemedicine applied to heart failure patients is a tool for recording and providing remote transmission, storage and interpretation of cardiovascular parameters and/or useful diagnostic images to allow for intensive home monitoring of patients with advanced heart failure, or during the vulnerable post-acute phase, to improve patient's prognosis and quality of life. Recently, several meta-analyses have shown that telemedicine-supported care pathways are not only effective but also economically advantageous. Benefits seem to be substantial, with a 30-35% reduction in mortality and 15-20% decrease in hospitalizations. Patients implanted with cardiac devices can also benefit from an integrated remote clinical management since all modern devices can transmit technical and diagnostic data. However, telemedicine may provide benefits to heart failure patients only as part of a shared and integrated multi-disciplinary and multi-professional 'chronic care model'. Moreover, the future development of remote telemonitoring programs in Italy will require the primary use of products certified as medical devices, validated organizational solutions as well as legislative and administrative adoption of new care methods and the widespread growth of clinical care competence to remotely manage the complexity of chronicity. Through this consensus document, Italian Cardiology reaffirms its willingness to contribute promoting a new phase of qualitative assessment, standardization of processes and testing of telemedicine-based care models in heart failure. By recognizing the relevance of telemedicine for the care of non-hospitalized patients with heart failure, its strategic importance for the design of innovative models of care, and the many challenges and opportunities it raises, ANMCO and SIC through this document report a consensus on the main directions for its widespread and sustainable clinical implementation.

Methodological issues on the use of administrative data in healthcare research: the case of heart failure hospitalizations in Lombardy region, 2000 to 2012.

BACKGROUND: Administrative data are increasingly used in healthcare research. However, in order to avoid biases, their use requires careful study planning. This paper describes the methodological principles and criteria used in a study on epidemiology, outcomes and process of care of patients hospitalized for heart failure (HF) in the largest Italian Region, from 2000 to 2012. METHODS: Data were extracted from the administrative data warehouse of the healthcare system of Lombardy, Italy. Hospital discharge forms with HF-related diagnosis codes were the basis for identifying HF hospitalizations as clinical events, or episodes. In patients experiencing at least one HF event, hospitalizations for any cause, outpatient services utilization, and drug prescriptions were also analyzed. RESULTS: Seven hundred one thousand, seven hundred one heart failure events involving 371,766 patients were recorded from 2000 to 2012. Once all the healthcare services provided to these patients after the first HF event had been joined together, the study database totalled about 91 million records. Principles, criteria and tips utilized in order to minimize errors and characterize some relevant subgroups are described. CONCLUSIONS: The methodology of this study could represent the basis for future research and could be applied in similar studies concerning epidemiology, trend analysis, and healthcare resources utilization.

Home-Based Telemanagement in Advanced COPD: Who Uses it Most? Real-Life Study in Lombardy.

Current evidence indicates that the benefits of tele-health may not be uniform across all patients. Therefore, to understand what specific variables influence use of home-based telemanagement in COPD, we conducted this retrospective study. A 6-month home-based telemanagement program (HTP) was offered to 1,074 COPD patients over a 4-year period. Multivarible linear regression analysis was used to identify predictors of HTP use/week (phone calls and specialist consultations) among all variables: clinical (body mass index, co-morbidities, HTP prescription not following an exacerbation, long-term oxygen therapy use, COPD severity, hospital readmissions, exacerbations and death), socio-demographic (sex, age, place of abode), smoking history, arterial blood gases (ABG), and specialist/general practitioner (GP) urgent need. Logistic regression was conducted to predict relapses/hospitalizations risk as well as the disease impact (COPD Assessment Test, CAT) at the end of the program. Presence of relapses (p < 0.001), ABGs (p < 0.001) and GP request (p < 0.001) were significantly associated with higher HTP-use. Smoking history (OR 1.542 [IC 95% 1.069-2.217], p = 0.020), specialist (OR 2.895 [2.144-3.910], p < 0.001) and GP consultations (OR 6.575 [4.521-9.561], p < 0.001) were the only independent risk factors for relapse. No predictor of hospitalization was found. High final CAT score was inversely related to oxygen therapy use (p = 0.001) and HTP prescription (p < 0.001), and positively related to presence of co-morbidities (p = 0.001) and baseline CAT (p < 0.001). This HTP in Lombardy shows that relapsers, people requiring several ABGs and urgent GP visits are the patient subgroup most likely to consume telemanagement services (scheduled and unscheduled). We propose a patient 'identikit' to improve prioritization for HTP prescriptions.

Home-based telesurveillance and rehabilitation after stroke: a real-life study.

BACKGROUND: After discharge from in-hospital rehabilitation, post-stroke patients should have the opportunity to continue the rehabilitation through structured programs to maintain the benefits acquired during intensive rehabilitation treatment. OBJECTIVE: The primary objective was to evaluate the feasibility of implementing an home-based telesurveillance and rehabilitation (HBTR) program to optimize the patient's recovery by reducing dependency degree. METHOD: Post-stroke patients were consecutively screened. Data were expressed as mean ± standard deviation (SD). 26 patients enrolled: 15 were sub-acute (time since stroke: 112 ± 39 days) and 11 were chronic (time since stroke: 470 ± 145 days). For 3 months patients were followed at home by a nurse-tutor, who provided structured phone support and vital signs telemonitoring, and by a physiotherapist (PT) who monitored rehabilitation sessions by videoconferencing. RESULTS: 23 patients completed the program; 16.7 ± 5.2 phone contacts/patient were initiated by the nurse and 0.9 ± 1.8 by the patients. Eight episodes of atrial fibrillation that required a change in therapy were recorded in two patients. Physiotherapists performed 1.2 ± 0.4 home visits, 1.6 ± 0.9 phone calls and 4.5 ± 2.8 videoconference-sessions per patient. At least three sessions/week of home exercises were performed by 31% of patients, two sessions by 54%. At the end of the program, global functional capacity improved significantly (P < 0.001), in particular, static (P < 0.001) and dynamic (P = 0.0004) postural balance, upper limb dexterity of the paretic side (P = 0.01), and physical performance (P = 0.002). Symptoms of depression and caregiver strain also improved. CONCLUSION: The home-based program was feasible and effective in both sub-acute and chronic post-stroke patients, improving their recovery, and maintaining the benefits reached during inpatient rehabilitation.

Home based telemedicine intervention for patients with uncontrolled hypertension--a real life non-randomized study.

BACKGROUND: Control of blood pressure is frequently inadequate in spite of availability of several classes of well tolerated and effective antihypertensive drugs. Several factors, including the use of suboptimal doses of drugs, inadequate or ineffective treatments and poor drug compliance may be the reason for this phenomenon. The aim of the current non- randomized study was to evaluate the effectiveness of a Home-Based Telemedicine service in patients with uncontrolled hypertension. METHODS: 74 patients were enrolled in a Home Based Telemedicine group and 94 patients in the Usual Care group. At baseline and at the end of the study, patients in both groups were seen in a cardiology office. Patients in Home Based Telemedicine group additionally were followed by a physician-nurse, through scheduled and unscheduled telephone appointments. These patients also received a blood pressure measuring device that could transmit the readings to a central data monitor via secure data connection. RESULTS: During the study period (80 ± 25 days), a total of 17401 blood pressure measurements were taken in the Home Based Telemedicine group corresponding to 236 ± 136 readings per patient and a mean daily measurement of 3 ± 1.7. The scheduled telephone contacts (initiated by the nurse) equaled to 5.2 ± 4.3/patient (370 in total) and the unscheduled telephone contacts (initiated by the patients) were 0.4 ± 0.9/patient (30 in total). The mean systolic blood pressure values decreased from 153 ± 19 mmHg to 130 ± 15 mmHg (p < 0.0001) at the end of the study and diastolic blood pressure values decreased from 89 ± 10 mmHg to 76 ± 11 mmHg (p < 0.0001). In the Usual Care group, the mean systolic blood pressure values decreased from 156 ± 16 mmHg to 149 ± 17 mmHg (p < 0.05) at the end of the study and diastolic blood pressure values decreased from 90 ± 8 mmHg to 86 ± 9 mmHg (p < 0.05). The changes in drug therapy initiated following telephone contacts were 1.81 ± 1.73 per patient. CONCLUSIONS: The addition of a structured physician-nurse approach supported by remote telemonitoring of blood pressure is likely to improve outcome in patients with uncontrolled hypertension.

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

BACKGROUND: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. METHODS AND ANALYSIS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. DISCUSSION: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. TRIAL REGISTRATION: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.

Home-based exercise program for people with residual disability following hospitalization for COVID-19: Randomized control trial.

BACKGROUND: The best exercise program for individuals with effort intolerance or hypoxia at rest and/or during exercise post-COVID-19 treatment who have already had in-hospital rehabilitation remains unknown. OBJECTIVE: We evaluated the efficacy of a home-based rehabilitation exercise program intervention that included teleconsultations with a specialist nurse. METHODS: This was a multicenter randomized controlled trial for individuals who had been diagnosed with, and treated for, COVID-19. Despite inpatient rehabilitation they still had effort intolerance; this was defined as being a) only able to walk <70 % of the predicted distance during the six-minute walking test (6MWT) and/or b) oxygen desaturation all day long/during effort. The primary outcome was effort tolerance, as evaluated by the 6MWT. Secondary outcomes were dyspnea, fatigue, spirometry, respiratory muscle evaluations, and oxygenation. The Intervention group performed 4 weeks of a self-directed exercise program with bi-weekly physiotherapist video calls; the Control group participated in physical activity howsoever they wished. Exercises were divided into 4 intensity levels according to disability and oxygen desaturation. The program progressively increased from low (walking, free-body exercise, sit-to-stand, and balance exercises) to high (speed walking with a pedometer, cycle ergometer, and strengthening exercises). RESULTS: We included 79 participants: 40 in the Intervention and 39 in the Control group. Mean (SD) age was 67.1 (10.3) years; 72 % (n = 57) were male. No intergroup differences in effort tolerance were found [Intervention 77.6 (75.4)m vs Control 49.5 (73.3)m (p = 0.109)]. Participants with 6MWT distance results < lower limit of normality values showed best improvements in mean (SD) effort tolerance: Intervention, 120.1 (75.8)m vs Control, 59.1 (75.6)m (p = 0.035). After 2 months, mean (SD) 6MWT distances in the 2 groups were similar: Intervention, 475.9 (82.4)m vs Control, 469.2 (118.9)m (p = 0.807). CONCLUSIONS: In individuals with residual disability post-COVID-19 and after inpatient rehabilitation, a home-based exercise program with teleconsultation significantly improves effort tolerance but only for people who had severe effort intolerance at baseline. DATABASE REGISTRATION: ClinicalTrials.gov number, NCT04821934.

Estimating maximum work rate during cardiopulmonary exercise testing from the six-minute walk distance in patients with heart failure.

Background: Exercise is recommended for patients with chronic heart failure (CHF) and its intensity is usually set as a percentage of the maximal work rate (MWR) during cardiopulmonary exercise testing (CPX) or a symptom-limited incremental test (SLIT). As these tests are not always available in cardiac rehabilitation due to logistic/cost constraints, we aimed to develop a predictive model to estimate MWR at CPX (estMWR@CPX) in CHF patients using anthropometric and clinical measures and the 6-min walk test (6 MWT), the most widely used exercise field test. Methods: This is a multicentre cross-sectional retrospective study in a cardiac rehabilitation setting. Six hundred patients with HF in New York Heart Association (NYHA) functional class I-III underwent both CPX and 6 MWT and, through multivariable linear regression analysis, we defined several predictive models to define estMWR@CPX. Results: The best model included 6 MWT, sex, age, weight, NYHA class, left ventricular ejection fraction (LVEF), smoking status and chronic obstructive pulmonary disease COPD (adjusted R2 = 0.55; 95% LoA -39 to 33 W). When LVEF was excluded as a predictor, the resulting model performed only slightly worse (adjusted R2 = 0.54; 95% LoA -42 to 34 W). Only in 34% of cases was the percentage difference between estMWR@CPX and real MWR@CPX <10% in absolute value. EstMWR@CPX tended to overestimate low values and underestimate high values of true MWR@CPX. Conclusions: Our results showed a lack of accuracy in the predictive model evaluated; therefore, for an accurate prescription of cycle-ergometer exercise training, it is necessary to assess MWR by CPX or SLIT.

Incremental prognostic value of functional impairment assessed by 6-min walking test for the prediction of mortality in heart failure.

Natriuretic peptides (NP) are recognized as the most powerful predictors of adverse outcomes in heart failure (HF). We hypothesized that a measure of functional limitation, as assessed by 6-min walking test (6MWT), would improve the accuracy of a prognostic model incorporating a NP. This was a multicenter observational retrospective study. We studied the prognostic value of severe functional impairment (SFI), defined as the inability to perform a 6MWT or a distance walked during a 6MWT < 300 m, in 1696 patients with HF admitted to cardiac rehabilitation. The primary outcome was 1-year all-cause mortality. After adjusting for the baseline multivariable risk model-including age, sex, systolic blood pressure, anemia, renal dysfunction, sodium level, and NT-proBNP-or for the MAGGIC score, SFI had an odds ratio of 2.58 (95% CI 1.72-3.88; p < 0.001) and 3.12 (95% CI 2.16-4.52; p < 0.001), respectively. Adding SFI to the baseline risk model or the MAGGIC score yielded a significant improvement in discrimination and risk classification. Our data suggest that a simple, 6MWT-derived measure of SFI is a strong predictor of death and provide incremental prognostic information over well-established risk markers in HF, including NP, and the MAGGIC score.

Tele-assistance Respiratory card: feasibility of self-reporting in patients with severe COPD.

OBJECTIVE: Respicard is a clinical scoring system used during tele-assistance of patients with chronic obstructive pulmonary disease (COPD) in order to assess variations during nurse phone contacts. Strategies to prevent occurrence of unreported COPD exacerbations are needed. We evaluated (1) comparison between administration of Respicard by the nurse during phone calls with self-administration by the patient and (2) patient compliance with Respicard use. SUBJECTS AND METHODS: From January to June 2011, every week for 6 months, patients with COPD enrolled in a tele-assistance program in Italy were invited to fill in Respicard at home according to their symptoms. Concurrently, on a weekly basis, a nurse telephoned the patients and filled in a similar card. The scoring of both Respicards was compared. At the end of the study, the patient's subjective utility and ease in implementing or discomfort in recording Respicard was assessed. RESULTS: In the 39 patients studied, the mean value of recorded nurse cards was 3.7±2.9, and the mean time spent by nurses to measure the first 52 cards was 7.7±2.7 min. Patient compliance was 78.2±33.4%. There was a significant positive correlation between nurse and patient card scores (R=0.98; p<0.0001). A similar correlation was observed when data from patients with or without exacerbations and with high or poor adherence to the program were considered (p<0.0001). Patients' acceptance of the self-recording was good. CONCLUSIONS: In patients with COPD with sufficient self-autonomy and followed up with tele-assistance, Respicard is a reliable system for recording symptoms of COPD and could be a good cost-cutting modality for continuing management of patients.