Telemonitoring Group Research Articles

Exploring the Use of Telemonitoring for Patients at High Risk for Hypertensive Disorders of Pregnancy in the Antepartum and Postpartum Periods: Scoping Review

BackgroundHigh blood pressure complicates 2% to 8% of pregnancies, and its complications are present in the antepartum and postpartum periods. Blood pressure during and after pregnancy is routinely monitored during clinic visits. Some guidelines recommend using home blood pressure measurements for the management and treatment of hypertension, with increased frequency of monitoring for high-risk pregnancies. Blood pressure self-monitoring may have a role in identifying those in this high-risk group. Therefore, this high-risk pregnancy group may be well suited for telemonitoring interventions.ObjectiveThe aim of this study was to explore the use of telemonitoring in patients at high risk for hypertensive disorders of pregnancy (HDP) during the antepartum and postpartum periods. This paper aims to answer the following question: What is the current knowledge base related to the use of telemonitoring interventions for the management of patients at high risk for HDP?MethodsA literature review following the methodological framework described by Arksey et al and Levac et al was conducted to analyze studies describing the telemonitoring of patients at high risk for HDP. A qualitative study, observational studies, and randomized controlled trials were included in this scoping review.ResultsOf the 3904 articles initially identified, 20 met the inclusion criteria. Most of the studies (13/20, 65%) were published between 2017 and 2018. In total, there were 16 unique interventions described in the 20 articles, all of which provide clinical decision support and 12 of which are also used to facilitate the self-management of HDP. Each intervention’s design and process of implementation varied. Overall, telemonitoring interventions for the management of HDP were found to be feasible and convenient, and they were used to facilitate access to health services. Two unique studies reported significant findings for the telemonitoring group, namely, spontaneous deliveries were more likely, and one study, reported in two papers, described inductions as being less likely to occur compared with the control group. However, the small study sample sizes, nonrandomized groups, and short study durations limit the findings from the included articles.ConclusionsAlthough current evidence suggests that telemonitoring could provide benefits for managing patients at high risk for HDP, more research is needed to prove its safety and effectiveness. This review proposes four recommendations for future research: (1) the implementation of large prospective studies to establish the safety and effectiveness of telemonitoring interventions; (2) additional research to determine the context-specific requirements and patient suitability to enhance accessibility to healthcare services for remote regions and underserved populations; (3) the inclusion of privacy and security considerations for telemonitoring interventions to better comply with healthcare information regulations and guidelines; and (4) the implementation of studies to better understand the effective components of telemonitoring interventions.

P373 Telemedicine and inflammatory bowel disease: Results of the IBD assistant pilot project

Abstract Background Telemedicine enables proper and immediate monitoring of the patient’s current health state, followed by well-timed and customised treatment. The aim of our study was to assess feasibility and safety of telemonitoring in Czech patients with inflammatory bowel disease (IBD). Furthermore, we wanted to evaluate the impact of telemonitoring on the number of outpatient′s visits and direct health-care cost. Methods We performed randomised controlled study including patients with IBD in stable remission on conventional therapy who were randomised either to telemonitoring (IBDA) or control (CTRL) group and were followed-up for 12 months. All IBDA patients had access to a specific web application which contained a set of questioners assessing disease activity and complications which were filled-in at least every 3 months. Evaluation of clinical activity was accompanied by measurement of faecal calprotectin (FC) at home using CalproSmart test. Individuals in the CTRL group were followed under the standard conditions as other outpatients. Results A total of 131 were included (42% males; 47% with Crohn′s disease) and randomised to IBDA (n = 94) or control group (n = 37). HBI/pMayo activity indexes were not significantly different at baseline (p = 0.636 and p = 0.853) and end of study (p = 0.517 and p = 0.890) in the two groups. Similarly, no significant difference in inflammatory markers (C-reactive protein, FC) was observed in either group (p>0.05). The occurrence of intercurrent infections (0.93 vs. 0.81 cases of infection/patient-year, p = 0.87) or the need for hospitalisations (1 vs. 0) was similar between the groups. The number of outpatient visits was significantly lower in the IBDA than in the CTRL group (median number in IBDA group 0, in the CTRL group 4.2 visits, respectively, p < 0.0001). Telemedicine led to a reduction in the direct annual health-care cost of patient follow-up by ~25% compared with the standard care. Conclusion Results of the first Czech IBD telemedicine study confirm the effectiveness and safety of the telemedicine approach, which led to a reduction in outpatient visits and savings in health-care costs while maintaining a high standard of health care. Acknowledgements: Supported by the IBD-Comfort Endowment Fund.

Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial.

Connected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown. This study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes. This was a pragmatic 52-week cluster-randomized controlled study among 11 primary care government practices in Malaysia. People with type 2 diabetes aged 18 and above, who had hemoglobin A1c ≥ 7.5% but less than 11.0% within the past 3months and resided in the state of Selangor. The intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated self-management by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service. The primary outcome was the change in HbA1c at 24weeks and 52weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy. A total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, - 0.05%; 95% CI - 0.10 to 0.00%) and at follow-up (week 52, - 0.03%; - 0.07 to 0.02%, p = 0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life. This study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed. ClinicalTrials.gov identifier: NCT02466880.

Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomized controlled trial.

TeleDiab‐2 was a 13‐month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI) initiation in subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%‐10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo‐BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow‐up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: −1.44% and G3: −1.48% vs. G1: −0.92%; P < 0.002). Moreover, target FBG was reached by twice as many patients in the telemonitoring groups as in the control group, and insulin doses were also titrated to higher levels. No severe hypoglycaemia was observed in the telemonitoring groups and mild hypoglycaemia frequency was similar in all groups. In conclusion, both telemonitoring systems improved glycaemic control to a similar extent, without increasing hypoglycaemic episodes.

Effectiveness of telemonitoring-enhanced support over structured telephone support in reducing heart failure-related healthcare utilization in a multi-ethnic Asian setting

Aims Our study aimed to compare the effectiveness of telemonitoring over structured telephone support in reducing heart failure-related healthcare utilization. Methods This was a non-randomised controlled study comparing 150 recently discharged heart failure patients enrolled into telemonitoring and 55 patients who only received structured telephone support after rejecting telemonitoring. Patient activation, knowledge and self-management levels were measured at baseline and the one year upon programme completion using the Patient Activation Measure, the Dutch Heart Failure Knowledge Scale and the Self-Care of Heart Failure Index respectively. Differences in heart failure-related and all-cause hospitalization rates, total bed days and mortality rates at 180 days and at one year, knowledge and self-management scores and total cost of care between groups at one year were analysed. Results Average age of telemonitoring was 57.9 years and 63.9 years for structured telephone support. Significant difference in adjusted 180-day all-cause bed days (telemonitoring: five days versus structured telephone support: 9.8 days), heart failure-related bed days (telemonitoring: 1.2 days versus structured telephone support: six days) and adjusted one-year heart failure-related bed days (telemonitoring: 2.2 days versus structured telephone support: 6.6 days) were observed. Telemonitoring was associated with reduced all-cause one-year mortality (hazard ratio 0.32, p = 0.02). Estimated mean maintenance and confidence scores were significantly higher in the telemonitoring group at one year. No differences in all-cause and HF-related readmission rates and knowledge levels were observed. The one-year total cost of care was predicted to be Singapore dollars (SG$) 2774.4 lower (p = 0.07) in telemonitoring. Conclusion In conclusion, telemonitoring was associated with lower all-cause and heart failure-related total bed days at 180 days, lower heart failure-related total bed days and total cost of care at one year as compared with structured telephone support.

Health-related quality of life on tele-monitoring for users with pacemakers 6 months after implant: the NORDLAND study, a randomized trial

BackgroundWith an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results.MethodsThe NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n = 25) or a conventional hospital monitoring (HM) group (n = 25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed.ResultsThe baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p = 0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p = 0.86) and the MLHFQ (TM:20.20; HM:28.96; p = 0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p = 0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p = 0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p < 0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30).ConclusionsThe NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers.Trial registrationClinicalTrials.gov NCT02237404, September 11, 2014.

The Impact of Telemonitoring on 30-day Readmissions for Patients Hospitalized with Heart Failure: A Safety-Net Hospital's Experience

Background Patients with heart failure (HF) are at risk for readmissions, either due to progression or related co-morbidities. Post-discharge telemonitoring (TM) provides support to HF patients during the critical hospital to home transition. Here, we provide a safety-net hospital's experience with HF telemonitoring(TM) Methods We conducted a retrospective chart review of admissions between November 2015 and December 2016 for 205 patients who were provided with TM kits at discharge. TM was achieved through internet-based weight, blood pressure, and symptoms monitoring. Pre-discharge HF education by the nurse practitioners (NPs) included instructions on the use of the telehealth kits. Abnormal values triggered a telephone call to the patients by the NPs. Data on demographics, health insurance, medications and TM usage were collected. Primary endpoints were 30-day all-cause and HF-related readmissions. Chi-square tests was used to compare all-cause and HF-related 30-day readmission rates for the TM group vs. the non-TM group and Fisher's exact test for 30-day readmission rates for participants with >= 50% TM usage compared to those with Results The mean age was 58 years, 43.4% were female, 51% had Medicaid or were self-pay, 61% had systolic HF and 87% were compliant with TM (>=50% use). 30-day readmission rates were calculated for all patients admitted for HF during the study duration, irrespective of their TM assignment, (n=1242). There was a statistically significant reduction in all-cause 30-day readmission rate in the TM group compared to the non-TM group (12.2% vs. 20.5%, p=0.0055) but no significant difference in 30-day HF-related readmission rates (9.3% vs. 12.8%, p=0.1563). TM compliance was associated with a reduction in all-cause readmission rates for those with >= 50% compliance compared to those with Conclusions In our unique patient population, TM reduced all-cause 30-day readmission in patients hospitalized for HF. When TM was optimally utilized (>=50%), there was a reduction in both all-cause and HF-related 30-day readmission rates. Figure 1 , Figure 2

Effect of tele-health care on quality of life in patients with severe COPD: a randomized clinical trial.

Background and objectiveTelemonitoring (TM) of patients with COPD has gained much interest, but studies have produced conflicting results. We aimed to investigate the effect of TM with the option of video consultations on quality of life (QoL) in patients with severe COPD.Patients and methodsCOPD patients at high risk of exacerbations were eligible for the 6-month study and a total of 281 patients were equally randomized to either TM (n=141) or usual care (n=140). TM comprised recording of symptoms, oxygen saturation, spirometry, and video consultations. Algorithms generated alerts if readings breached thresholds. Both groups filled in a health-related QoL questionnaire (15D©) and the COPD Assessment Test (CAT) at baseline and at 6 months. Within-group differences were analyzed by paired t-test.ResultsMost of the enrolled patients had severe COPD (86% with Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 and 45% with admission for COPD within the last year, respectively). No difference in drop-out rate and mortality was found between the groups, and likewise there was no difference in 15D or CAT at baseline. At 6 months, a significant improvement of 0.016 in 15D score (p=0.03; minimal clinically important difference 0.015) was observed in the TM group (compared to baseline), while there was no improvement in the control group −0.003 (p=0.68). After stratifying 15D score at baseline to <0.75 or ≥0.75, respectively, there was a significant difference in the <0.75 TM group of 0.037 (p=0.001), which is a substantial improvement. No statistically significant changes were found in CAT score.ConclusionCompared to the nonintervention group, TM as an add-on to usual care over a 6-month period improved QoL, as assessed by the 15D questionnaire, in patients with severe COPD, whereas no difference between groups was observed in CAT score.

Comparative effectiveness of telemonitoring versus usual care for type 2 diabetes: A systematic review and meta-analysis

Aims This study evaluated clinical effectiveness of telemonitoring on the management of patients with type 2 diabetes. Methods We searched Ovid-Medline, Ovid-EMBASE, and the Cochrane Library to identify randomized controlled trials that compared telemonitoring and usual care in patients with type 2 diabetes. Results Thirty-eight studies (6855 patients) were included. Telemonitoring was associated with a significant decrease in glycated haemoglobin levels compared to usual care (weighted mean difference –0.42%, 95% confidence interval –0.56 to –0.27) but there was evidence of heterogeneity (I2 = 96.9%). Telemonitoring was associated with a significant glycated haemoglobin reduction when biological data were transmitted through a web-based device weekly, when voice feedback was performed daily or immediately and when patients were provided with counselling. Telemonitoring also reduced glycated haemoglobin level in studies that monitored patients’ medication adherence, provided counselling, education and alarm message. The rate of achieving glycated haemoglobin levels of < 7% was 1.8 times higher in the telemonitoring group compared to the usual care group (risk ratio 1.83, 95% confidence interval 1.35 to 2.47, I2 = 0%). There was also significant reduction in systolic blood pressure (weighted mean difference –1.33 mm Hg) and body mass index (weighted mean difference –0.25 kg/m2), but the clinical relevance of these results can be questioned. The data available on patient satisfaction, quality of life, medication adherence, prescription changes, stress and depression were limited. Conclusions Telemonitoring interventions may be a better option than usual care in improving glycated haemoglobin control of patients with type 2 diabetes. Further studies should assess clinical benefit according to specific delivery modes of the intervention and patient-reported outcomes.

Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure

Aims The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up. Methods Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t0); 142 CHF patients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t1) with a final evaluation at 79 months (time point: t2). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t1 –t2). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs. Results Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group (p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) (p = 0.87). Discussion An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHF patients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038).

Cost-utility analysis on telemonitoring of users with pacemakers: The PONIENTE study

Introduction Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital. Methods Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital (n = 52) or TM (n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs). Results There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS’s perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (€46.51 versus €109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (€31.82 versus €73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group. Discussion The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial

SummaryBackgroundStudies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care.MethodsThis study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366.Findings1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, −3·5 mm Hg [95% CI −5·8 to −1·2]; telemonitoring, −4·7 mm Hg [–7·0 to −2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference −1·2 mm Hg [95% CI −3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups.InterpretationSelf-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care.FundingNational Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.

The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF).

Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n=90) or a usual care group (n=91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p=0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.

Telemonitoring in subjects with newly diagnosed heart failure with reduced ejection fraction: From clinical research to everyday practice

Introduction Heart failure is increasingly common, and characterised by frequent admissions to hospital. To try and reduce the risk of hospitalisation, techniques such as telemonitoring (TM) may have a role. We wanted to determine if TM in patients with newly diagnosed heart failure and ejection fraction <40% reduces the risk of readmission or death from any cause in a ‘real-world’ setting. Methods This is a retrospective study of 124 patients (78.2% male; 68.6 ± 12.6 years) who underwent TM and 345 patients (68.5% male; 70.2 ± 10.7 years) who underwent the usual care (UC). The TM group were assessed daily by body weight, blood pressure and heart rate using electronic devices with automatic transfer of data to an online database. Follow-up was 12 months. Results Death from any cause occurred in 8.1% of the TM group and 19% of the UC group (p = 0.002). There was no difference between the two groups in all-cause hospitalisation, either in the number of subjects hospitalised (p = 0.7) or in the number of admissions per patient (p = 0.6). There was no difference in the number of heart-failure-related readmissions per person between the two groups (p = 0.5), but the number of days in hospital per person was higher in the UC group (p = 0.03). Also, there were a significantly greater number of days alive and out of hospital for the patients in the TM group compared with the UC group (p = 0.0001). Discussion TM is associated with lower any-cause mortality and also has the potential to reduce the number of days lost to hospitalisation and death.

DOP030 The efficacy of home telemonitoring vs. conventional follow-up: a randomised controlled trial among teenagers with inflammatory bowel disease

Conventional follow-up of teenagers with inflammatory bowel diseases (IBD) is done during scheduled outpatient visits regardless of how well the patient feels. We designed a telemonitoring strategy for early recognition of flares and compared its efficacy with conventional follow-up. Flarometer. Algorithm with advice on treatment and the timing of re-measurement. Multicentre randomised trial in children aged 10–19 years with IBD in clinical remission at baseline. Participants assigned to telemonitoring received automated alerts to complete a symptom score and send a stool sample for calprotectin measurement. This resulted in an individual prediction for flare with associated treatment advice and test interval. In conventional follow-up the health check interval was left to the physician’s discretion. Primary endpoint was cumulative incidence of disease flares. Secondary endpoints were percentage of participants with a positive change in quality-of-life and cost-effectiveness of the intervention. We included 170 participants (84 telemonitoring; 86 conventional follow-up). At 52 weeks the mean number of face-to-face visits was significantly lower in the telemonitoring group compared with conventional follow-up (3.6 vs. 4.3, p < 0.001). The incidence of flares (33 vs. 34%) and the proportion of participants reporting positive change in quality-of-life (56% vs. 46%) were similar. Mean annual cost-saving was €89 and increased to €360 in those compliant to the protocol. Telemonitoring is as safe as conventional follow-up, reduces outpatient visits and societal costs. This strategy is attractive for teenagers and families, and health professionals may be interested in using it to keep teenagers who are well out of hospital and ease pressure on overstretched outpatient services. (Trial registration: NTR3759.)

Comparative Effectiveness of Telemonitoring Versus Usual Care for Heart Failure: A Systematic Review and Meta-analysis

BackgroundThis study aimed to evaluate the effectiveness of telemonitoring (TM) in the management of patients with heart failure (HF). Methods and ResultsWe searched Ovid-Medline, Ovid-Embase, and the Cochrane Library for randomized controlled trials published through May 2016. Outcomes of interest included clinical effectiveness (mortality, hospitalization, and emergency department visits) and patient-reported outcomes. TM was defined as the transmission of individual biologic data, such as weight, blood pressure, and heart rate. Thirty-seven randomized controlled trials (9582 patients) of TM met the inclusion criteria: 24 studies on all-cause mortality, 17 studies on all-cause hospitalization, 12 studies on HF-related hospitalization, and 5 studies on HF-related mortality. The risks of all-cause mortality (risk ratio [RR] 0.81, 95% confidence interval [CI] 0.70–0.94) and HF-related mortality (RR 0.68, 95% CI 0.50–0.91) were significantly lower in the TM group than in the usual care group. TM showed a significant benefit when ≥3 biologic data are transmitted or when transmission occurred daily. TM also reduced mortality risk in studies that monitored patients' symptoms, medication adherence, or prescription changes. ConclusionsTM intervention reduces the mortality risk in patients with HF, and intensive monitoring with more frequent transmissions of patient data increases its effectiveness.

Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study

We determined the impact of a remote blood glucose telemonitoring program with feedback in type 2 diabetes mellitus patients fasting during Ramadan compared to conventional self-monitoring method. A twelve-week cluster randomised study, with 85 participants who wish to fast for at least 15 days during Ramadan was conducted. Self-measurement and transmission of blood glucose results were performed six times daily during Ramadan. Results were transmitted to a secure website for review with feedback from case manager if necessary. The control group received usual care. The main outcome was the number of participants experiencing hypoglycaemia during Ramadan and at the end of the study. During Ramadan, the number of participants reporting hypoglycaemia was significantly lower in the telemonitoring group [Odds ratio (OR): 0.186, 95% confidence interval: 0.04–0.936; p = 0.04]. Similarly, the proportion of participants reporting symptomatic hypoglycaemia at the end of the study was significantly lower in the telemonitoring group (OR: 0.257, 95% CI: 0.07–0.89; p = 0.03). A reduction of 1.07% in glycated haemoglobin levels was observed in the telemonitoring group compared to 0.24% in the control group (p < 0.01). Overall, telemonitoring was a useful adjunct to reduce the risk of hypoglycaemia during Ramadan with no deterioration in glycaemic control

Impact of initial active engagement in self-monitoring with a telemonitoring device on glycemic control among patients with type 2 diabetes

This study aimed to investigate the effect of patient engagement in self-monitoring with a telemonitoring device on glycemic control among patients with type 2 diabetes. We conducted a subanalysis of the telemonitoring device study in Kaiser Permanente Northern California members. We divided the telemonitoring group into 53 frequent and 54 infrequent users based on self-monitoring of blood glucose (SMBG) frequency of the first 6 weeks. The frequency of SMBG transmitted from the telemonitoring device was examined over 24 weeks. Clinic and laboratory tests were collected at baseline, 6 weeks and 6 months. There was no significant difference in baseline HbA1c level between the two groups. After 6 months, change in HbA1c was −2.4 ± 1.6% among frequent users and −1.5 ± 1.5% among infrequent users (p = 0.003). The proportion of patients achieving target HbA1C level at 6 months was significantly higher among frequent users than among infrequent users. An increased frequency of SMBG was significantly correlated with a reduction in HbA1c at 6 months. In conclusion, initial active engagement in self-monitoring with a telemonitoring device could provide incremental improvement of glycemic control over 6 months.

0541 ACCEPTANCE AND IMPACT OF TELEMEDICINE IN PATIENT SUB-GROUPS WITH OBSTRUCTIVE SLEEP APNEA: ANALYSIS FROM THE TELE-OSA RANDOMIZED CLINICAL TRIAL

The Tele-OSA study reported the impact of two telemedicine mechanisms (OSA web education [Emmi, Emmi Solutions Inc] and CPAP tele-monitoring with automated patient feedback [U-Sleep; ResMed Corp]) on CPAP adherence. This study specifically analyzes patient sub-groups regarding telemedicine acceptance and effectiveness. Tele-OSA was a 4-arm randomized trial conducted at Kaiser Permanente sleep center (Fontana, CA) in patients referred for suspected OSA; 3-month CPAP adherence was the primary outcome. Results showed: 1) Tele-monitoring improved Medicare compliance (69.6% vs. 57.5%; p<0.01); 2) Web-education did not impact compliance but improved show-rates to their diagnostic appointment (68.7% vs. 62.7%; p=0.02). We evaluated patient sub-groups based on gender, age, OSA severity, and whether web-education was viewed. 1,455 subjects (49.0% male, 49.1 ± 12.5 years, AHI 22.7 ± 23.9) were enrolled; 556 prescribed CPAP. Web-education Acceptance—726 received web-education, only 242 (33.3%) viewed the program. Gender nor age impacted view rates. Those that viewed had better: 1) appointment show-rates (91.7% vs. 57.1%, p<0.001); 2) CPAP Medicare compliance (75.7% vs. 63.6%, p=0.06) especially those ≥55 years old. Tele-monitoring Acceptance—Of 263 patients in tele-monitoring groups, 22 (8.4%) declined feedback messaging. No patients requested discontinuation of messaging during follow-up. Age—Adherence was better in the “elderly” (55+ years; n=501) than the “middle-aged” (35–55; n=715) and “young” (18–35; n=239); (average minutes on all days 279.1 ± 137.2 versus 239.7 ± 145.9 and 217.9 ± 147.6; both p<0.01). Furthermore, tele-monitoring improved adherence in the “middle-aged” (262.5 ± 138.9 vs. 214.2 ± 150.0 minutes, p<0.01) and “elderly” (314.8 ± 121.5 vs. 252.2 ± 142.5 minutes, p<0.001) but not the “young” (212.2 ± 135.0 vs. 221.9 ± 157.4 minutes, p=0.79). Gender—Gender did not impact adherence (men 258.0 ± 139.1 vs. women 246.9 ± 150.9 minutes, p=0.38) nor web-education view rates. Furthermore, the impact of tele-monitoring was similar in men and women. OSA severity—319 (41.3%) had mild OSA, 199 (25.7%) moderate, and 255 (33.0%) severe. Tele-monitoring improved adherence in moderate/severe OSA (288.2 ± 132.0 vs. 238.1 ± 149.0 minutes; p<0.001) but not mild OSA (249.8 ± 141.9 vs. 220.4 ± 146.7 minutes; p=0.18). CPAP tele-monitoring with patient feedback messaging has high acceptance while effectiveness was primarily in moderate/severe OSA. While web-education program view rates were lower than expected, viewing status may predict future CPAP adherence. ASMF Strategic Research Grant 104-SR-13 & ResMed Corp.

Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

BackgroundAlthough a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services.MethodsA 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual’s normal range. The study’s primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths.ResultsThree hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI 0.79–1,04); p = 0.16 and IRR = 0.91 (95% CI 0,75 – 1.04); p = 0.16, respectively]. The readmission rate for AECOPD and/or any cause was, however, significantly lower in the TM group with respect to the control one [IRR = 0.43 (95% CI 0.19–0.98); p = 0.01 and 0.46 (95% CI 0.24–0.89); p = 0.01, respectively].ConclusionStudy results showed that in areas where medical services are well established, TM does not significantly improve HRQL in patients with COPD who develop AE. Although not effective in reducing hospitalizations, TM can nevertheless facilitate continuity of care during hospital-to-home transition by reducing the need for early readmission.Trial registrationRetrospectively registered on January 2012, ClinicalTrials.gov Identifier: NCT01513980.