Telemonitoring Group Research Articles

Impact of Home Mobile Phone-Based Telemonitoring in Preventing Exacerbations and Hospitalizations Among Patients with Chronic Obstructive Pulmonary Disease: An IMTEC Study

COPD is a major public health problem due to its high morbidity and mortality. The evolution of COPD is marked by the occurrence of acute exacerbations (AECOPD). One of the major causes of AECOPD is non-adherence treatment. Telemedicine is an accessible educational tool that can help physicians to provide continuous, accessible educational support and monitoring for patients with COPD. Objectives: This study aimed to determine the impact of therapeutic education via phone-based telemedicine on ED visits and/or hospitalizations for AECOPD. Methods: This is a randomized controlled trial carried out in the emergency department (ED) of Fattouma Bourguiba Monastir over a period of 7 consecutive months, including patients admitted with a final diagnosis of AECOPD. Patients were randomly assigned to receive standard care (STD) or weekly phone-based telemonitoring (TLM). Outcomes (exacerbation and the need for hospitalization for AECOPD) were assessed at a 1-, 3-, and 6-month follow-up after being discharged from the hospital. Results: We included 163 patients (57 patients in the TLM group and 106 patients in the STD group). The mean age of the study population was 66.5 ± 12.5 years. The TLM group exhibited a significantly lower risk of ED visits for AECOPD compared to the STD group, with an odds ratio of 0.13 (95% CI: 0.04–0.40) and a p-value ≤ 0.001. Additionally, the TLM group had a notably lower hospitalization rate for AECOPD compared to the control group (15.8% vs. 44.3%, respectively), with an odds ratio of 0.23 (95% CI: 0.10–0.52) and a p-value < 0.001. The all-cause death rate was also lower in the TLM group at the 6-month follow-up. Conclusions: Telemedicine represents an innovative approach that could improve the management of patients with COPD.

Enhancing cardiac postoperative care: a smartwatch-integrated remote telemonitoring platform for health screening with ECG analysis.

The integration of smartwatches into postoperative cardiac care transforms patient monitoring, systematically tracking vital signs and delivering real-time data to a centralized platform. This study focuses on developing a platform for seamless integration, assessing reliability, and evaluating the impact on post-cardiac surgery. The goal is to establish a robust foundation for understanding the efficacy and dependability of smartwatch-based telemonitoring, enhancing care for this population. A total of 108 cardiac surgery patients were divided into telemonitoring (TLM) and control (CTL) groups. The TLM group utilized smartwatches for continuous monitoring of vital parameters (SpO2, HR, BP, ECG) over 30 ± 3 days. Statistical analyses (Pearson, Intraclass Correlation, Bland-Altman, Tost Test) were employed to compare smartwatch measurements with traditional methods. Significant correlations and concordance were observed, particularly in HR and BP measurements. Challenges were noted in SpO2 measurement. The ECG algorithm exhibited substantial agreement with cardiologists (Kappa: 0.794; p > 0.001), highlighting its reliability. The telemonitoring platform played a crucial role in early detection of clinical changes, including prompt Emergency Department (ED) visits, contributing significantly to preventing outcomes that could lead to mortality, such as asymptomatic Atrioventricular block. Positive patient responses affirmed technological efficacy, especially in identifying cardiac arrhythmias like atrial fibrillation. The integration of smartwatches into remote telemonitoring for postoperative cardiac care demonstrates substantial potential, improving monitoring and early complication detection, thereby enhancing patient outcomes. The FAPO-X Study (Assisted Digital Telemonitoring with Wearables in Patients After Cardiovascular Surgery; NCT05966857) underscores the promising role of telemonitoring in postoperative cardiac care.

P042 EFFECTIVENESS OF STRUCTURED TELEMONITORING BLOOD PRESSURE IN PRIMARY CARE: UNCONTROLLED HYPERTENSE COHORTS

Introduction: E-health has emerged as a pivotal resource in healthcare delivery due to its widespread coverage, ease, and acceptance, particularly for chronic diseases. We aim to establish the effectiveness of structured telemonitoring in managing blood pressure among patients with uncontrolled essential arterial hypertension. Methods: An analytical observational retrospective cohort study of uncontrolled hypertensive patients aged ≥ 18 was conducted, with follow-ups at 150 and 240 days. Patients in the telemonitoring cohort were provided with validated digital blood pressure monitors, underwent remote monitoring, and received weekly feedback for 30 days from a multidisciplinary team. Conversely, the non-telemonitoring cohort received usual care consisting of attendance to in-person medical consultations as part of our institution's cardiovascular-risk-prevention program. Results: 350 patients were included, with median ages of 55 and 66 years in the telemonitoring and non-telemonitoring cohorts, respectively. Over the 240-day follow-up, the telemonitoring group achieved a significant reduction in systolic (-20.99 mmHg; 95% CI 14.99- 27.50; p 0.000) and diastolic blood pressure (- 14.99 mmHg; 95% CI 10.00- 18.99; p 0.000) compared to usual care, which demonstrated reductions of 19.99 mmHg (95% CI 16.49- 22.50; p 0.000) in systolic blood pressure and 6.50 mmHg, (95% CI 4.50- 9.00; p 0.000) in diastolic blood pressure. Conclusion: Telemonitoring is an effective strategy for patients with uncontrolled arterial hypertension, leading to earlier and significant blood pressure reductions.

Training and provision of mobility aids to promote autonomy and mobility of older patients in a geriatric emergency department: A protocol for a randomized controlled trial.

Older adults have higher rates of emergency department (ED) admissions when compared to their younger counterparts. Mobility is the ability to move around, but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric EDs. This study aims to evaluate the efficacy of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on fear of falling, mobility, quality of life and risk of falls up to 3 and 6 months in older adults cared for in an ED. A randomized controlled trial will be carried out in the ED. Participants will be randomized and allocated into three groups, as follows: A) walking aid group will be trained for the use of a walking aid and receive guidance on safe gait; B) walking aid and telemonitoring group will receive training for the use of a walking aid, guidance on safe gait, and telemonitoring (every two weeks for first three months); C) Control group will receive only guidance on safe gait. Patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces, gait speed, muscle strength, functionality, quality of life, fear of falling, history of falls, cognition and mood before the intervention. Gait time and fear of falling will be assessed again after the intervention in ED. Finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 and 6 months after discharge from the geriatric ED through a telephone interview. Provision of walking aids in the geriatric ED is currently recommended. This study will be the first randomized controlled trial that will evaluate the impact of training and provision of these devices in the ED. Trial registration number: NCT05950269.

Web-based telemonitoring of visual function and self-reported postoperative outcomes in cataract care: international multicenter randomized controlled trial.

To compare web-based, self-administered follow-up after cataract surgery to conventional face-to-face follow-up. Eye clinics in the Netherlands, Austria, and Germany. Randomized controlled trial with an embedded method comparison study (ClinicalTrials.gov: NCT04809402). Routine patients with cataract were randomized into 2 groups: The telemonitoring group undertook web-based vision self-assessments and questionnaires from home, while the usual care group received conventional care. All participants had a 4- to 6-week postoperative clinic visit for safety and validation purposes. Outcomes included, the web test's accuracy for assessing postoperative visual acuity (VA) and refractive error, adverse event rates, and patient-reported outcome measurements (PROMs). 94 participants (188 eyes) were enrolled. Web-based uncorrected distance VA testing demonstrated a negligible mean difference (-0.03 ± 0.14 logMAR) when compared with conventional Early Treatment Diabetic Retinopathy Study chart testing, with 95% limits of agreement ranging from -0.30 to 0.24 logMAR. The web-based refraction assessment overestimated the postoperative refractive error (mean difference in spherical equivalent 0.15 ± 0.67 diopters), resulting in a poorer corrected distance VA compared with subjective refraction (mean 0.1 vs -0.1 logMAR). Rates of adverse events and unscheduled consultations were minimal across both groups. Preoperative and postoperative PROM questionnaires had a 100% response rate. Visual functioning (Catquest-9SF and National Eye Institute Visual Function Questionnaire-25) improved postoperatively (mean improvement -0.80 and 16.70, respectively) and did not significantly differ between the 2 groups. The patients with cataract in this study effectively provided postoperative outcome data using a web interface. Both conventional and web-based follow-ups yielded similar PROMs and adverse event rates. Future developments should reduce the variability in the web-based VA test and yield representative refraction outcomes.

Impacto de la telemonitorización como sistema para una adecuada titulación y adaptación de la CPAP domiciliaria en la apnea obstructiva del sueño (proyecto T-CPAP)

IntroductionContinuous Positive Airway Pressure (CPAP) constitutes the most effective treatment for Obstructive Sleep Apnea (OSA). Automatic titration systems (ATS) are predominantly used to achieve adaptation to the equipment. Home CPAP devices allow telemonitoring (TM) of the same parameters as those provided by ATS but with access to continuous usage data. Under this premise, we conducted a study on the potential validity of TM for home CPAP devices as a titration system, its direct impact on proper adaptation (AD) to the equipment, and secondarily on the healthcare resources employed to achieve it. Material and methodsAn observational study involving 318 patients with OSA who were titrated using TM to achieve AD to CPAP. Patients with OSA were consecutively recruited and evaluated at 1, 3, and 6 months after initiating treatment. Results were compared with a historical group of 307 patients with OSA who achieved AD to CPAP using ATS. Additionally, we assessed the impact on required healthcare resources. ResultsPatients with OSA who initiated CPAP treatment with TM over the first six months showed a similar AD rate compared to the historical group titrated using ATS, with lower resource usage in the TM group. ConclusionData provided by TM of home CPAP devices allow for titration and achieving similar AD as with ATS in non-complex patients.

Weight telemonitoring of heart failure versus standard of care in a real-world setting: Results on mortality and hospitalizations in a 6-month nationwide matched cohort study.

Evaluating the benefit of telemonitoring in heart failure (HF) management in real-world settings is crucial for optimizing the healthcare pathway. The aim of this study was to assess the association between a 6-month application of the telemonitoring solution Chronic Care Connect™ (CCC) and mortality, HF hospitalizations, and associated costs compared with standard of care (SOC) in patients with a diagnosis of HF. From February 2018 to March 2020, a retrospective cohort study was conducted using the largest healthcare insurance system claims database in France (Système National des Données de Santé) linked to the CCC telemonitoring database of adult patients with an ICD-10-coded diagnosis of HF. Patients from the telemonitoring group were matched with up to two patients from the SOC group based on their high-dimensional propensity score, without replacement, using the nearest-neighbour method. A total of 1358 telemonitored patients were matched to 2456 SOC patients. The cohorts consisted of high-risk patients with median times from last HF hospitalization to index date of 17.0 (interquartile range: 7.0-66.0) days for the telemonitoring group and 27.0 (15.0-70.0) days for the SOC group. After 6 months, telemonitoring was associated with mortality risk reduction (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.56-0.89), a higher risk of first HF hospitalization (HR 1.81, 95% CI 1.55-2.13), and higher HF healthcare costs (relative cost 1.38, 95% CI 1.26-1.51). Compared with the SOC group, the telemonitoring group experienced a shorter average length of overnight HF hospitalization and fewer emergency visits preceding HF hospitalizations. The results of this nationwide cohort study highlight a valuable role for telemonitoring solutions such as CCC in the management of high-risk HF patients. However, for telemonitoring solutions based on weight and symptoms, consideration should be given to implement additional methods of assessment to recognize imminent worsening of HF, such as impedance changes, as a way to reduce mortality risk and the need for HF hospitalizations. Further studies are warranted to refine selection of patients who could benefit from a telemonitoring system and to confirm long-term benefits in high-risk and stable HF patients.

Bottom-Up Analysis of Telemonitoring Costs: A Case Study in Slovenian Primary Care.

Telemonitoring improves clinical outcomes in patients with arterial hypertension (AH) and type 2 diabetes (T2D), however, cost structure analyses are lacking. This study seeks to explore the cost structure of telemonitoring for the elderly with AH and T2D in primary care and identify factors influencing costs for potential future expansions. Infrastructure, operational, patient participation, and out-of-pocket costs were determined using a bottom-up approach. Infrastructure costs were determined by dividing equipment and telemonitoring platform expenses by the number of participants. Operational and patient participation costs were determined by considering patient training time, data measurement/review time, and teleconsultation time. The change in out-of-pocket costs was assessed in both groups using a structured questionnaire and 12-month expenditure data. Statistical analysis employed an unpaired sample t-test, Mann-Whitney U test, and chi-square test. A total of 117 patients aged 71.4±4.7 years were included in the study. The telemonitoring intervention incurred an annual infrastructure costs of €489.4 and operational costs of €97.3 (95% CI 85.7-109.0) per patient. Patient annual participation costs were €215.6 (95% CI 190.9-241.1). Average annual out-of-pocket costs for both groups were €345 (95% CI 221-469). After 12 months the telemonitoring group reported significantly lower out-of-pocket costs (€132 vs. €545, p<0.001), driven by reduced spending on food, dietary supplements, medical equipment, and specialist check-ups compared to the standard care group. To optimise the cost structure of telemonitoring, strategies like shortening the telemonitoring period, developing a national telemonitoring platform, using patient devices, integrating artificial intelligence into platforms, and involving nurse practitioners as telemedicine centre coordinators should be explored.

Implementation of blood pressure and blood glucose telemonitoring in the elderly population in primary care practices: a right step towards integrated care?

Background: Arterial hypertension (AH) and type 2 diabetes (T2D) represent a significant burden on the public health system, with an exceptionally high prevalence in patients aged ≥65 years. One of the possible solutions to improve disease outcomes, promote integrated care with high patient engagement and support self-management in patients with AH and T2D at the primary care level is blood pressure and blood glucose telemonitoring.&#x0D; Target Population: Patients aged ≥65 years with AH and T2D &#x0D; Stakeholders Engagement: In designing the intervention, we involved stakeholders at the micro-level (patients, health professionals), meso-level (managers of the included community health centres, representatives of the national association of general practitioners and associations of patients with chronic diseases) and macro-level (representatives of the Medical Faculty and Ministry of Health). &#x0D; Description Of Intervention: We conducted a multicentre, prospective, randomised, controlled pilot study. Patients aged ≥ 65 years with AH and T2D were randomised 1:1 to an mHealth intervention or standard care group. Patients in the intervention group measured their blood pressure twice weekly and their blood glucose once monthly. The readings were synchronously transmitted via a mobile application to the telemonitoring platform, where they were reviewed by a general practitioner who indicated changes in the measurement scheme or performed a teleconsultation. Patients in the control group received standard care. The intervention lasted 12 months.&#x0D; Results Of Intervention: We enrolled 63 patients with a mean age of 71.9 ± 5.0 years, of whom 36 (57.1%) were men. The mean duration of AH was 15.1 ± 11.2 years and that of T2D was 9.1 ± 8.1 years. Mean systolic blood pressure at baseline was 141.2 ± 13.9 mmHg, diastolic blood pressure was 77.8 ± 9.0 mmHg and HbA1c was 7.2 ± 1.2%. At baseline, we found no significant differences between groups in sociodemographic and clinical variables. Compared with standard care, we observed an additional reduction in systolic blood pressure of -9.1 mmHg (95% CI -16.5 to -1.7, p=0.018), diastolic blood pressure of -2.3 mmHg (95% CI -6.1 to 1.4, p=0.215) and HbA1c of -0.7% (95% CI -1.2 to -0.1, p=0.022) in the telemonitoring group after 12 months. The intervention proved feasible and acceptable among included health professionals and patients (qualitative methods). &#x0D; Take-Home Message: Telemonitoring of blood pressure and blood glucose is a feasible, acceptable and clinically effective method of remote care for elderly patients, particularly with regard to systolic blood pressure and blood glucose control in the first 12 months. The major limitation of remote care in elderly remains the lack of skills in using modern technology. To maximise clinical and cost-effective impact, careful patient selection is required (i.e., patients with newly diagnosed disease, poor adherence, poor disease control).&#x0D; Next Steps: For further scale-up and implementation, further research is needed to assess the long-term impact of telemonitoring. Due to the high implementation costs, other applications of telemonitoring could be tested, with telemonitoring serving only as a short-term educational tool in the hands of registered nurses and primary care physicians during more complex health education interventions.&#x0D; &#x0D; &#x0D; &#x0D;

Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission

Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. ClinicalTrials.gov Identifier: NCT04062461.

Newcard telemonitoring system improves survival at a lower cost than traditional approaches in chronic heart failure patients as assessed by data extract from the French National Health Data System

Abstract Background Despite widespread use of telemonitoring (TLM) for chronic heart failure (CHF) patients, outcome data remain scarce and medico – economic assessment not routinely addressed. In this setting, the French National Health Data System (SNDS) can be used to comprehensively collect health care costs for the entire French population whatever the type of TLM system. Purpose The aim of this study is to assess the health economic impact of telemonitoring among 1057 patients presenting heart failure matched with a control group selected in the SNDS Methods All patients TLM at least 3 months between 2017 and 2020 were included. For each patient identified by his single social security number (case), anonymised data was retrieved from the SNDS. A control group (CG) was randomly selected from an exhaustive extraction of SNDS of patients with heart failure without TLM. This CG was matched in a 1:3 ratio to TLM patients using a propensity score including baseline characteristics (i.e. gender, age group, social disadvantage index, presence of comorbidities (renal insufficiency, coronary disease, diabetes, cancer), presence of treatments (beta blockers, Sacubitril, aldosterone antagonists, aspirin/Clopidogrel, anticoagulants)). Costs were evaluated using French National Health Insurance perspective using €2022. Binomial negative GEE models were used on matched data sets to assess differences. Results The matching rate between patients included in the TLM arm and the SNDS database was excellent at 99%. Hence, 1,057 TLM patients were matched to 3,171 patients with heart failure. In the telemonitoring group (TLM), patients were 74 years old (±12,3), 68.4 % male, mean left ventricular ejection fraction 41 % and the mean follow-up by the TLM system was 618 days. At 1-year, 2-year and 3-year follow-up, survival rates were respectively of 96%, 91% and 87% for TLM patients vs 93%, 83% and 76% among CG patients (p&amp;lt;0.0001, figure 1). At 6 months, the monthly cost for managing patients was 1,403.2 € in the TLM group vs 1,251.5 € in the CG (p=0.0064). At 12 months, 949.52 € in the TLM group vs 1,114.40 in the CG (p&amp;lt;0.0001). At 24 months, 591.31 € in the TLM group vs 1,064.20 in the CG (p&amp;lt;0.0001). Conclusion While using common evaluation methods seems to be unsatisfactory, economic evaluation both costs and outcomes of an intervention could be more appropriate. The French SNDS is a powerful tool to implement such a type of study. The results presented here show on one hand a significant decrease in mortality in the TLM. On the economic hand, we show here an increase in cost during the first 6 months of the telemonitoring balanced with a significant decrease at 12 and 24 months. Especially, those data place telemonitoring of heart failure as a real improvement in the care pathway which needs time to be effective but is able to have an effect even on the mortality rate

Telemonitoring: An opportunity in cystic fibrosis lung transplant recipients

IntroductionTelemedicine has been successfully employed in a wide range of conditions, such as such as chronic lung disease and COVID-19. This study evaluate the role of telemonitoring for the early diagnosis of acute lung allograft dysfunction in cystic fibrosis adults who underwent lung transplant (LuTx). Quality of life and functional level achieved during a 12 months follow up were assessed. MethodsPatients were randomized into two groups; control group received traditional hospital-based follow-up, whereas patients in the intervention group received, on top of standard care, a telemonitoring device, with a pulse oximeter and a spirometer integrated. Telemonitoring data were digitally transmitted to our centre. ResultsSixteen patients were enrolled in each group. No statistically significant difference was found between the two groups in terms of incidence of allograft dysfunction, time from onset of symptoms to diagnosis and time of occurrence from LuTx. Moreover, both groups achieved similar quality of life and functional level. With reference to the telemonitoring group: 1) hospital reported data were consistent with those being remotely registered; 2) adherence to telemonitoring decreased during the follow up; 3) the majority of patients reported a high degree of satisfaction. ConclusionThe COVID19 pandemic highlighted the necessity to investigate alternative practices to treat chronically ill individuals. Telemonitoring is a valuable tool to improve quality care to LuTx recipients.

Adding Pharmacist-Led Home Blood Pressure Telemonitoring to Usual Care for Blood Pressure Control: A Systematic Review and Meta-Analysis

Health systems have been quickly adopting telemedicine throughout the United States, especially since the onset of the COVID-19 pandemic. However, there are limited data on whether adding pharmacist-led home blood pressure (BP) telemonitoring to office-based usual care improves BP. We searched PubMed/MEDLINE and Embase for randomized controlled trials from January 2000 until April 2022, comparing studies on pharmacist-led home BP telemonitoring with usual care. Six randomized controlled trials, including 1,550 participants, satisfied the inclusion criteria. There were 774 participants in the pharmacist-led telemonitoring group and 776 in the usual care group. The addition of pharmacist-led telemonitoring to usual care was associated with a significant decrease in systolic BP (mean difference -8.09, 95% confidence interval -11.15 to -5.04, p<0.001, I2=72%) and diastolic BP (mean difference -4.19, 95% confidence interval -5.58 to -2.81, p<0.001, I2=42%) compared with usual care. In conclusion, this meta-analysis showed that adding pharmacist-led home BP telemonitoring to usual care achieves better BP control than usual care alone.

Effect of telemonitoring on readmissions for acute exacerbation of chronic obstructive pulmonary disease: A randomized clinical trial.

Acute exacerbations of chronic obstructive pulmonary disease are associated with high morbidity and mortality. Telemonitoring may reduce the frequency of hospitalization. The aim of this study was to investigate the effect of telemonitoring on hospitalization rates for acute exacerbations of chronic obstructive pulmonary disease. Patients were recruited during hospitalization and equally randomized to telemonitoring or usual care. Telemonitoring participants recorded symptoms and monitored oxygen saturation, heart rate, peak expiratory flow, and body weight. Alerts were generated if readings breached thresholds. Acute exacerbations of chronic obstructive pulmonary disease hospitalizations during the 6 months intervention were compared using logistic regression, and time to first hospitalization was assessed using Cox proportional hazard modeling. The incidence rates for acute exacerbations of chronic obstructive pulmonary disease hospitalization were compared using a negative binomial regression model with between-group comparisons expressed as incidence rate ratios. The telemonitoring group was used as reference. A total of 222 patients were randomized. 37/112 (33%) in the control group and 31/110 (28%) in the telemonitoring group experienced acute exacerbations of chronic obstructive pulmonary disease hospitalization during the intervention period, odds ratio of 1.26, confidence interval 0.71-2.23, p = 0.4. No difference was seen in time to first hospitalization, hazard ratio 1.23, CI 0.77-1.99, p = 0.4. The number of hospitalizations in the intervention period was 66 in the control group and 42 in the telemonitoring group, with incidence rate ratio 1.42, confidence interval 1.04-1.95, p = 0.03. Adjustment for dyspnea score, smoking, and cohabitation status did not change the results, incidence rate ratio 1.44, confidence interval 1.05-1.99, p = 0.02. Patients who received telemonitoring experienced significantly fewer acute exacerbations of chronic obstructive pulmonary disease hospitalizations, although the overall risk of having at least one hospitalization and the time to first hospitalization was similar between the two groups.

The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial

BackgroundThe effect of telemedicine solutions in diabetes remains inconclusive. However, telemedicine studies have shown a positive trend in regards to glycemic control. The telemedicine interventions that facilitate adjustment of medication seems to improve glycemic control more effectively. Hence, it is recommended that future telemedicine studies for patients with diabetes include patient-specific suggestions for changes in medicine. Hence, the aim of the trial is to explore the effect of telemonitoring in patients with type 2 diabetes (T2D) on insulin therapy.MethodsThe trial is an open-label randomized controlled trial with a trial period of 3 months conducted in two sites in Denmark. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group will use a continuous glucose monitor (CGM), an insulin pen, an activity tracker, and smartphone applications throughout the trial. Hospital staff will monitor the telemonitoring group and contact the subjects by telephone repeatedly throughout the trial period. The usual care group will use a blinded CGM the first and last 20 days of the trial and will use a blinded insulin pen for the entire period.The primary endpoint will be changed from baseline in CGM time in range (3.9–10.0 mmol/L) 3 months after randomization. Secondary endpoints include change from baseline in glycated hemoglobin (HbA1c), total daily dose, time above range, and time below range 3 months after randomization. Exploratory endpoints include health-related quality of life, diabetes-related quality of life, etc.DiscussionThe DiaMonT trial will test a telemonitoring setup including various devices. Such a setup may be criticized, because it is impossible to determine which element(s) add to the potential effect. However, it is not possible and counterproductive to test the elements individually, since it is the full telemedicine setup that is being evaluated. The DiaMonT trial is the first Danish trial to explore the effect of telemonitoring on patients on insulin therapy. Thus, the DiaMonT trial has the potential to form the basis for the implementation of telemedicine for patients with T2D in Denmark.Trial registrationClinicalTrials.gov NCT04981808. Registered on 8 June 2021.

ISPAD Clinical Practice Consensus Guidelines 2022: Ramadan and other religious fasting by young people with diabetes.

ISPAD Clinical Practice Consensus Guidelines 2022: Ramadan and other religious fasting by young people with diabetes.

Multimodal Telemonitoring for Weight Reduction in Patients With Sleep Apnea: A Randomized Controlled Trial

Telemonitoring the use of CPAP devices and remote feedback on device data effectively optimizes CPAP adherence in patients with OSA. Can expanding the scope of telemonitoring and remote feedback to body weight (BW), BP, and physical activity enhance efforts for BW reduction in Patients with OSA receiving CPAP? Participants were recruited from patients at 16 sleep centers in Japan with OSA and obesity who were receiving CPAP therapy. Obesity was defined as a BMI of≥ 25kg/m2, based on Japanese obesity guidelines. Implementation of CPAP telemonitoring was enhanced with electronic scales, BP monitors, and pedometers that could transmit data from devices wirelessly. Participants were randomized to the multimodal telemonitoring group or the usual CPAP telemonitoring group and were followed up for 6months. Attending physicians provided monthly telephone feedback calls to the usual CPAP telemonitoring group on CPAP data obtained remotely. In the multimodal telemonitoring group, physicians additionally encouraged participants to reduce their BW, after sharing the remotely obtained data on BW, BP, and step count. The primary outcome was set as≥ 3%BW reduction from baseline. One hundred sixty-eight participants (BMI, 31.7 ± 4.9kg/m2) completed the study, and≥ 3%BW reduction occurred in 33 of 84 participants (39.3%) and 21 of 84 participants (25.0%) in the multimodal telemonitoring and usual CPAP telemonitoring groups, respectively (P= .047). Whereas no significant differences were found between the two groups in the change in office and home BP, daily step counts during the study period were significantly higher in the multimodal telemonitoring group than in the usual CPAP telemonitoring group (4,767 steps/d [interquartile range (IQR), 2,864-6,617 steps/d] vs3,592 steps/d [IQR, 2,117-5,383 steps/d]; P= .02) INTERPRETATION: Multimodal telemonitoring may enhance BW reduction efforts in patients with OSA and obesity. UMIN Clinical Trials Registry; No.: UMIN000033607; URL: www.umin.ac.jp/ctr/index.htm.

Titration Clinic Assisted By Telemonitoring For Guideline Directed Medical Therapy Optimization

Introduction : A large proportion of patients with heart failure with reduced ejection fraction (HFrEF) receive suboptimal doses of Guideline Directed Medical Therapy (GDMT). We hypothesize that a titration clinic assisted by non-invasive telemonitoring results in greater GDMT optimization. Methods : Patients were randomized to GDMT delivered by a titration clinic assisted by non-invasive telemonitoring vs. usual care. Eligibility included HFrEF on at least one GDMT medication at <50% of target dose. Patients in the telemonitoring assisted group used wireless devices to transmit heart rate, blood pressure, and weight daily from their homes to a HIPAA compliant platform. HF nurses, pharmacists, and physicians reviewed the data along with clinical and biochemical profile every 2-3 weeks to recommend treatment optimization following ACC/AHA Guidelines. This workflow was repeated cyclically until patients reached target doses or further adjustments were not possible due to intolerance. Control patients had clinical encounters and phone calls as determined by treating provider. The primary outcome was the within-group percentage (%) of target dose achieved at 6 months compared to baseline for angiotensin receptor-neprilysin inhibitor, angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ARNI/ACEI/ARB), β-blockers (BB), and mineralocorticoid receptor antagonists (MRA). Wilcoxon one-tailed signed-rank test was used for analysis. Results : Participants (n=49) were randomized to telemonitoring (n=24) or usual care (n=25), baseline characteristics between groups including age, sex, NYHA class, LVEF, BNP, and GFR were similar overall. Patients in the telemonitoring group had a change in target dose % [±SD] from baseline to 6 months of 25.7% [20.8] to 52.8% [27.1] (P< 0.01) for ARNI/ACEI/ARB, 51.7% [47.5] to 73.1% [42.8] (P< 0.03) for BB, and 59% [42.6] to 109% [71.7] (P< 0.01) for MRA. In the control group, changes at six months were 30% [21.6] to 33.4% [21.2] (P= 0.34) for ARNI/ARA/ACE, 42.5% [40.6] to 50% [40.8] (P= 0.16) for BB, and 92.1% [47.9] to 110.5% [87.5] (P= 0.5) for MRA. Conclusions : A titration clinic assisted by non-invasive telemonitoring is feasible and may improve rapid optimization of GDMT in clinical practice. A larger study is needed to confirm our findings and assess the impact on clinical outcomes. : A large proportion of patients with heart failure with reduced ejection fraction (HFrEF) receive suboptimal doses of Guideline Directed Medical Therapy (GDMT). We hypothesize that a titration clinic assisted by non-invasive telemonitoring results in greater GDMT optimization. : Patients were randomized to GDMT delivered by a titration clinic assisted by non-invasive telemonitoring vs. usual care. Eligibility included HFrEF on at least one GDMT medication at <50% of target dose. Patients in the telemonitoring assisted group used wireless devices to transmit heart rate, blood pressure, and weight daily from their homes to a HIPAA compliant platform. HF nurses, pharmacists, and physicians reviewed the data along with clinical and biochemical profile every 2-3 weeks to recommend treatment optimization following ACC/AHA Guidelines. This workflow was repeated cyclically until patients reached target doses or further adjustments were not possible due to intolerance. Control patients had clinical encounters and phone calls as determined by treating provider. The primary outcome was the within-group percentage (%) of target dose achieved at 6 months compared to baseline for angiotensin receptor-neprilysin inhibitor, angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ARNI/ACEI/ARB), β-blockers (BB), and mineralocorticoid receptor antagonists (MRA). Wilcoxon one-tailed signed-rank test was used for analysis. : Participants (n=49) were randomized to telemonitoring (n=24) or usual care (n=25), baseline characteristics between groups including age, sex, NYHA class, LVEF, BNP, and GFR were similar overall. Patients in the telemonitoring group had a change in target dose % [±SD] from baseline to 6 months of 25.7% [20.8] to 52.8% [27.1] (P< 0.01) for ARNI/ACEI/ARB, 51.7% [47.5] to 73.1% [42.8] (P< 0.03) for BB, and 59% [42.6] to 109% [71.7] (P< 0.01) for MRA. In the control group, changes at six months were 30% [21.6] to 33.4% [21.2] (P= 0.34) for ARNI/ARA/ACE, 42.5% [40.6] to 50% [40.8] (P= 0.16) for BB, and 92.1% [47.9] to 110.5% [87.5] (P= 0.5) for MRA. : A titration clinic assisted by non-invasive telemonitoring is feasible and may improve rapid optimization of GDMT in clinical practice. A larger study is needed to confirm our findings and assess the impact on clinical outcomes.

Telemonitoring: An Opportunity to Improve Multidisciplinary Care in Lung Transplanted Patients

PurposeTelemedicine has been successfully employed in a wide range of specialties. We hereby present the results of a pivotal study we ran in our centre just before the COVID19 pandemic.MethodsThis was a prospective study including all adult cystic fibrosis patients who underwent lung transplant (LuTx) from September 2017 to August 2019. Patients were randomized into two groups; patients assigned to the first arm (intervention) received a home medical assistant (HMA) system device, to which a pulse oximeter and a spirometer with reusable turbine were integrated; they were asked to perform a spirometry and register their SpO2 at rest and on effort on a twice-weekly basis. All the data were digitally transmitted to our centre, where physiotherapists and physicians were able to analyse them real-time. Both the groups received traditional hospital-based follow-up.Results32 patients were enrolled, 16 in each group. No statistically significant difference was found between the two groups (see Table 1).With reference to the telemonitoring group:- Adherence to telemonitoring significantly decreased during the 12months period of follow up (see figure 1).- Hospital reported data were consistent with the last being registered with the HMA device.- Of note, two patients were requested to anticipate their hospital routine visit because of a FEV1 decrease being reported on their HMA device, in order to rule out possible acute lung allograft dysfunction.- 13 out of 16 patients reported a high degree of satisfaction with the telemonitoring experience.ConclusionThe COVID19 pandemic highlighted the necessity to investigate alternative practices to treat chronically ill individuals. In our study, telemonitoring proved to be a valuable tool to improve quality health care to LuTx recipients, especially for those who live far from the transplant centre. We are now implementing this approach scheduling online video consultations. Further research should be focused on standardizing quality of telemedicine services.

Cost-Effectiveness Evaluation of a Remote Monitoring Programme Including Lifestyle Education Software in Type 2 Diabetes: Results of the Educ@dom Study.

IntroductionTelemedicine programs using health technological innovation to remotely monitor the lifestyles of patients with type 2 diabetes (T2D) can improve glycaemic control and thus reduce the incidence of complications as well as management costs. In this context, an assessment was made of the 1-year and 2-year cost-effectiveness of the EDUC@DOM telemonitoring and tele-education program.MethodsThe EDUC@DOM study was a multicentre randomized controlled trial conducted between 2013 and 2017 that compared a telemonitoring group (TMG) to a control group (CG) merged with health insurance databases to extract economic data on resource consumption. Economic analysis was performed from the payer perspective, and direct costs and indirect costs were considered. The clinical outcome used was the intergroup change in glycated haemoglobin (HbA1c) levels from baseline. Missing economic data were imputed using multiple imputation, and fitted values from a generalized linear mixed model were used to calculate the incremental cost-effectiveness ratio (ICER). Bootstrapped 95% confidence ellipses were drawn in the cost-effectiveness plan.ResultsThe main analysis included data from 256 patients: 126 in the TMG and 130 in the CG. Incremental costs over 1 and 2 years were equal to €2129 and €5101, respectively, in favour of the TMG. Once imputed and adjusted for confounding factors, the TMG trends to a 21% cost decrease over 1 and 2 years of follow-up (0.79 [0.58; 1.08], p = 0.1452 and 0.79 [0.61; 1.03], p = 0.0879, respectively). The EDUC@DOM program led to a €1334 cost saving and a 0.17 decrease in HbA1c over 1 year and a €3144 cost saving and a 0.14 decrease in HbA1c over 2 years. According to the confidence ellipse, EDUC@DOM was a cost-effective strategy.ConclusionThis study provides additional economic information on telemonitoring and tele-education programs to enhance their acceptance and promote their use. In the light of this work, the EDUC@DOM program is a cost-saving strategy in T2D management.Trial registrationThis trial was registered in the Clinical Trials Database on 27 September 2013 under no. NCT01955031 and bears ID-RCB no. 2013-A00391-44.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01207-1.