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.

A Sensor-Based Upper Limb Treatment in Hemiplegic Patients: Results from a Randomized Pilot Study.

In post-stroke patients, the disabling motor deficit mainly affects the upper limb. The focus of rehabilitation is improving upper limb function and reducing long-term disability. This study aims to evaluate the feasibility of using the Gloreha Aria (R-Lead), a sensor-based upper limb in-hospital rehabilitation, compared with conventional physiotherapist-led training in subacute hemiplegic patients. Twenty-one patients were recruited and randomised 1:1 to a sensor-based group (treatment group TG) or a conventional group (control group, CG). All patients performed 30 sessions of 30 min each of dedicated upper limb rehabilitation. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) was the primary evaluation., both as a motor score and as individual items. Secondary evaluations were Functional Independence Measure; global disability assessed with the Modified Barthel Index; Motor Evaluation Scale for UE in stroke; power grip; and arm, shoulder, and hand disability. All the enrolled patients, 10 in the TG and 11 in the CG, completed all hand rehabilitation sessions during their hospital stay without experiencing any adverse events. FMA-UE scores in upper limb motor function improved in both groups [delta change CG (11.8 ± 9.2) vs. TG (12.7 ± 8.6)]. The score at T1 for FMA joint pain (21.8 vs. 24 best score) suggests the use of the Gloreha Aria (R-Lead) as feasible in improving arm function abilities in post-stroke patients.

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.

COVID-19 teleassistance and teleconsultation: a matched case-control study (MIRATO project, Lombardy, Italy).

Background: During the COVID-19 pandemic, telemedicine has been recognised as a powerful modality to shorten the length of hospital stay and to free up beds for the sicker patients. Lombardy, and in particular the areas of Bergamo, Brescia, and Milan, was one of the regions in Europe most hit by the COVID-19 pandemic. The primary aim of the MIRATO project was to compare the incidence of severe events (hospital readmissions and mortality) in the first three months after discharge between COVID-19 patients followed by a Home-Based Teleassistance and Teleconsultation (HBTT group) program and those discharged home without Telemedicine support (non-HBTT group). Methods: The study was designed as a matched case-control study. The non-HBTT patients were matched with the HBTT patients for sex, age, presence of COVID-19 pneumonia and number of comorbidities. After discharge, the HBTT group underwent a telecare nursing and specialist teleconsultation program at home for three months, including monitoring of vital signs and symptoms. Further, in this group we analysed clinical data, patients' satisfaction with the program, and quality of life. Results: Four hundred twenty-two patients per group were identified for comparison. The median age in both groups was 70 ± 11 years (62% males). One or more comorbidities were present in 86% of the HBTT patients and 89% in the non-HBTT group (p = ns). The total number of severe events was 17 (14 hospitalizations and 3 deaths) in the HBTT group and 40 (26 hospitalizations and 16 deaths) in the non-HBTT group (p = 0.0007). The risk of hospital readmission or death after hospital discharge was significantly lower in HBTT patients (Log-rank Test p = 0.0002). In the HBTT group, during the 3-month follow-up, 5,355 teleassistance contacts (13 ± 4 per patient) were performed. The number of patients with one or more symptoms declined significantly: from 338 (78%) to 183 (45%) (p < 0.00001). Both the physical (ΔPCS12: 5.9 ± 11.4) component and the mental (ΔMCS12: 4.4 ± 12.7) component of SF-12 improved significantly (p < 0.0001). Patient satisfaction with the program was very high in all participants. Conclusions: Compared to usual care, an HBTT program can reduce severe events (hospital admissions/mortality) at 3-months from discharge and improve symptoms and quality of life. Clinical trial registration: www.ClinicalTrials.gov, NCT04898179.

Usability of a continuous oxygen saturation device for home telemonitoring.

Background: The emergency for the COVID-19 pandemic has led to greater use of home telemonitoring devices. The aim of this study was to assess the usability of continuous home-monitoring care with an oxygen saturation device on post-COVID-19 patients. Method: The system consists of a digital continuous pulse oximeter and a smartphone with an App, which were provided to patients. A survey composed of a standard Post-Study System Usability Questionnaire, and a satisfaction questionnaire was exploited to conduct a usability and feasibility analysis of the service. Results: A total of 29 patients (17.2% female) with a mean age of 65 ± 11.5 years were enrolled: 20 patients were smartphone users (69%) with a mean age of 60.2 ± 9.5 years, and 9 patients (31%) did not own a smartphone (mean age 76.8 ± 5.9). The monitoring period was 1 month: a total of 444 recordings were conducted, 15 recordings per patient averagely. In total, 82% of the recordings performed did not require any intervention, while 18% led to the production of a report and subsequent intervention by a nurse who verified, together with the specialist, the need to intervene (i.e. the patient accessed the clinic for medical control and/or modification of oxygen therapy). A total of 17 patients compiled a usability questionnaire. The service was perceived as useful and well-structured, although it often required caregiver support. Conclusions: Using continuous home-monitoring care with an oxygen saturation device seems feasible and useful for patients who could be followed at home avoiding going back to the hospital every time a trend oximetry is needed. Further improvements in connections, data flow processes, and simplifications, based on patients' feedback, are needed to scale up the service.

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.

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.

Treatment prescription, adherence, and persistence after the first hospitalization for heart failure: A population-based retrospective study on 100785 patients.

BACKGROUND: This study evaluates, in a real-world setting, to what extent the recommended therapies by international guidelines, are prescribed after a first hospitalization for heart failure (HF), and to analyse adherence and persistence, and the effect of treatment adherence on mortality and re-hospitalization. METHODS: From the Lombardy healthcare administrative database, we analysed patients discharged after their incident HF, from 2000 to 2012. Adherence was defined as the proportion of days covered (PDC) ≥80% adjusted for hospitalizations and persistence as the absence of discontinuation of therapy for >30 days. A logit model was used to determine the effect of patients' adherence on mortality and readmissions. RESULTS: Of 100422 HF patients (52% males, age 75 ± 12 years), 86846 (87%) had a prescription for angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACE/ARBs), 64135 (64%) for beta-blockers (BB), and 36893 (37%) for mineralocorticoid receptor antagonists (MRAs), as mono-, bi- or tri-therapy. In patients on monotherapy, PDC was 78 ± 22% for ACE/ARBs, 69 ± 29% for BB and 54 ± 29% for MRAs; in those on bi-therapy, PDC was 63 ± 31% for ACEI/ARBs+BB, 41 ± 29% for ACEI/ARBs+MRAs, and 40 ± 26% for MRAs+BB; for patients on tri-therapy, PDC was 42 ± 28%. Medication persistence was present in 47% of patients treated with ACEI/ARBs, in 35% of patients treated with BB and in 14% of patients treated with MRAs. Re-hospitalizations and in mortality were significantly reduced in adherent patients (p < 0.000). CONCLUSIONS: Polypharmacy is associated with an increased rate of non-adherence and non-persistence in incident HF. Non-adherence is associated with an increased risk of mortality and re-hospitalizations.

Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to determine the feasibility and efficacy of a 6-month tele-rehabilitation home-based program, designed to prevent falls in older adults with 1 or more chronic diseases (cardiac, respiratory, neuromuscular or neurologic) returning home after in-hospital rehabilitation for their chronic condition. Patients were eligible for selection if they had experienced a fall during the previous year or were at high risk of falling. DESIGN: Randomized controlled trial. Tele-rehabilitation consisted of a falls prevention program run by the physiotherapist involving individual home exercise (strength, balance, and walking) and a weekly structured phone-call by the nurse inquiring about the disease status and symptoms and providing patient support. SETTING AND PARTICIPANTS: Two hundred eighty-three patients (age 79 ± 6.6 years; F = 59%) with high risk of falls and discharged home after in-hospital rehabilitation were randomized to receive home-based program (intervention group, n = 141) or conventional care (control group, n = 142). MEASURES: Incidence of falls at home in the 6-month period (primary outcome); time free to the first fall and proportion of patients sustaining ≥2 falls (secondary outcomes). RESULTS: During the 6 months, 85 patients fell at least once: 29 (20.6%) in the Intervention Group versus 56 (39.4%) in the control group (P < .001). The risk of falls was significantly reduced in the intervention group (relative risk =0.60, 95% confidence interval: 0.44-0.83; P < .001). The mean ± standard deviation time to first fall was significantly longer in intervention group than control group (152 ± 58 vs 134 ± 62 days; P = .001). Significantly, fewer patients experienced ≥2 falls in the intervention group than in the control group: 11 (8%) versus 24 (17%), P = .020. CONCLUSIONS: A 6-month tele-rehabilitation home-based program integrated with medical/nursing telesurveillance is feasible and effective in preventing falls in older chronic disease patients with a high risk of falling.

Maugeri Centre for Telehealth and Telecare: A real-life integrated experience in chronic patients.

Management of chronic diseases in a progressively aging population is a major issue in western industrialized countries and telehealth is one way to ensure the continuity of care in chronic illness. We describe here our personal experience in a telehealth and telecare centre in Italy. Between January 2000 and December 2015, 1635 elderly patients (71% male) with one or more comorbidities have undergone a telehealth program tailored to their specific disease: chronic obstructive pulmonary disease (COPD)/chronic respiratory insufficiency; amyotrophic lateral sclerosis/neuromuscular diseases; chronic heart failure (CHF); post-stroke; and post-cardiac surgery patients discharged from hospital after an acute event. COPD and CHF represent the majority of patients treated (accounting for 80%). Interventions performed by the nurse tutor account for 39-82% of all activities in the five different programs. Specialist second opinion represents 12-27% of the health staff activities. Previously reported results show a reduction of the re-hospitalization rate and costs, and increase in quality of life and patient satisfaction with the service. A multidisciplinary telehealth and telecare integrated approach can provide efficient management for the growing number of complex patients.

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.

Home-based hand rehabilitation with a robotic glove in hemiplegic patients after stroke: a pilot feasibility study.

OBJECTIVE: To evaluate the feasibility and safety of home rehabilitation of the hand using a robotic glove, and, in addition, its effectiveness, in hemiplegic patients after stroke. METHODS: In this non-randomized pilot study, 21 hemiplegic stroke patients (Ashworth spasticity index ≤ 3) were prescribed, after in-hospital rehabilitation, a 2-month home-program of intensive hand training using the Gloreha Lite glove that provides computer-controlled passive mobilization of the fingers. Feasibility was measured by: number of patients who completed the home-program, minutes of exercise and number of sessions/patient performed. Safety was assessed by: hand pain with a visual analog scale (VAS), Ashworth spasticity index for finger flexors, opponents of the thumb and wrist flexors, and hand edema (circumference of forearm, wrist and fingers), measured at start (T0) and end (T1) of rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip test) were also measured at T0 and T1. RESULTS: Patients performed, over a mean period 56 (49-63) days, a total of 1699 (1353-2045) min/patient of exercise with Gloreha Lite, 5.1 (4.3-5.8) days/week. Seventeen patients (81%) completed the full program. The mean VAS score of hand pain, Ashworth spasticity index and hand edema did not change significantly at T1 compared to T0. The MI, NHPT and Grip test improved significantly (p = 0.0020, 0.0156 and 0.0024, respectively) compared to baseline. CONCLUSION: Gloreha Lite is feasible and safe for use in home rehabilitation. The efficacy data show a therapeutic effect which need to be confirmed by a randomized controlled study.

Home-Based Telemedicine in Patients with Chronic Neck Pain.

OBJECTIVE: To investigate if a structured physician-directed, nurse-managed, home-based telemedicine (HBT) program, consisting of scheduled/unscheduled phone surveillance, can reduce pain in patients with chronic neck pain. DESIGN: This is a prospective randomized controlled study conducted on outpatients. Following outpatient rehabilitation, patients (n = 100) were consecutively randomized to a 6-month HBT program (HBT group) or no HBT but only the recommendation to continue exercising at home (control group). At baseline and after 6 months, pain severity (visual analog scale) and disability (Neck Disability Index) were evaluated. RESULTS: At 6 months, neck pain and disability declined in both groups (P < 0.001 for both groups, both parameters), but the decline was significantly more marked in the HBT group (P = 0.001, both parameters). At 6 months, 87.2% of HBT patients and 65.9% of control subjects were performing home exercises (in the range of 2-7 exercise sessions/wk). Pain and disability scores were correlated to participation in the HBT program, patients' perception of HBT, and adherence to home exercises. CONCLUSIONS: Home-based telemedicine may be a useful additional tool to help physicians in the management of chronic neck pain.

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.

Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial.

BACKGROUND: Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programmes are effective in all older population studied. However, the application of these programmes may not be the same in all National health care setting and, consequently, needs to be evaluated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention programme at home has never been explored. METHODS AND DESIGN: This will be a two-group randomised controlled trial aiming to evaluate the effects of a home-based intervention programme delivered by a multidisciplinary health team. The home tele-management programme, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at hospital discharge. The programme will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed for 6 months after hospital discharge. A nurse-tutor telephone support and tele-exercise will characterize the intervention programme. People in the control group will receive usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios. DISCUSSION: To date, no adequately powered studies have investigated the effect of the Information and Communication Technologies (ICT) in a home fall prevention program. We aim the program will be feasible in terms of intensity and characteristics, but particularly in terms of patient and provider compliance. The results of the economic evaluation could provide information about the cost-effectiveness of the intervention and the effects on quality of life. In case of shown effectiveness and cost effectiveness, the program could be implemented into health services settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02487589 ).

A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing patients' quality of life and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions. However, no data exist in patients with combined COPD/CHF. We planned a randomized controlled trial to investigate the feasibility and efficacy of an integrated, home-based, medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD/CHF. The purpose of the paper is to describe the rationale and design of the trial. METHODS/DESIGNS: Patients, after inpatient rehabilitation, were randomly assigned to the intervention or control group, followed for 4 months at home, then assessed at 4 and 6 months. The intervention group followed a telesurveillance (telephone contacts by nurse and remote monitoring of cardiorespiratory parameters) and home-based rehabilitation program (at least three sessions/week of mini-ergometer exercises, callisthenic exercises and twice weekly pedometer-driven walking, plus telephone contacts by a physiotherapist). Telephone follow-up served to verify compliance to therapy, maintain exercise motivation, educate for early recognition of signs/symptoms, and verify the skills acquired. At baseline and 4 and 6 months, the 6-min Walk Test, dyspnea and fatigue at rest, oxygenation (PaO2/FiO2), physical activity profile (PASE questionnaire), and QoL (Minnesota and CAT questionnaires) were assessed. During the study, serious clinical events (hospitalizations or deaths) were recorded. DISCUSSION: Currently, no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF. Our study will show whether this approach is effective in the management of such complex, frail patients who are at very high risk of exacerbations. TRIAL REGISTRATION: Network per la prevenzione e la sanità pubblica, CCM, Ministero della Salute "Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso: studio di implementazione, validazione e impatto," registered on 14 January 2014. ClinicalTrials.gov Identifier: NCT02269618 , registered on 17 October 2014.

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.

Does 6-Month Home Caregiver-Supervised Physiotherapy Improve Post-Critical Care Outcomes?: A Randomized Controlled Trial.

OBJECTIVE: This study aims to determine whether a 6-month home physiotherapy program can improve outcomes in critical care survivors. DESIGN: Forty-eight consecutive patients were randomized. The treatment group underwent 2 sessions/day of breathing retraining and bronchial hygiene, physical activity (mobilization, sit-to-stand gait, limb strengthening), and exercise re-conditioning whereas controls underwent standard care. Maximum inspiratory/expiratory pressures (MIP/MEP), forced volumes, blood gases, dyspnea, respiratory rate, disability, peripheral force measurements, perceived health status (Euroquol-5D), patient adherence/satisfaction, safety, and costs were assessed. RESULTS: Outcomes of treatment versus controls: MIP 14 ± 17 vs. -0.2 ± 14 cm H2O, MEP 27 ± 27 vs. 6 ± 21 cm H2O both P < 0.03; in addition, quality of life (Euroquol-5D) (P = 0.04), FEV1 (P = 0.03), dyspnea (P = 0.002), and respiratory rate (P = 0.009) were significantly improved for treated cardiorespiratory patients only. Eighty-three percent of the treated patients were decannulated versus 14% of controls (P = 0.01). Compliance was high (74 ± 25%) and there were no side effects. The majority (87.4%) expressed satisfaction with the program. Treatment cost was 459&OV0556;/patient/month. CONCLUSIONS: Carrying over regular bronchial hygiene techniques, physical activity, and exercise into the home after long critical care stays is safe and has a beneficial effect on respiratory muscles, decannulation, pulmonary function, and quality of life.

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.