BackgroundTelemonitoring of patients with chronic heart failure (CHF) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization.ObjectiveThe goal of the MOBIle TELemonitoring in Heart Failure Patients Study (MOBITEL) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation.MethodsPatients were randomly allocated to pharmacological treatment (control group) or to pharmacological treatment with telemedical surveillance for 6 months (tele group). Patients randomized into the tele group were equipped with mobile phone–based patient terminals for data acquisition and data transmission to the monitoring center. Study physicians had continuous access to the data via a secure Web portal. If transmitted values went outside individually adjustable borders, study physicians were sent an email alert. Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause.ResultsThe study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone (“never beginners”). Four patients did not finish the study due to personal reasons. Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001). Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients.ConclusionsTelemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.

Objective. To compare the efficacy and safety of subcutaneous (SC) versus oral administration of methotrexate (MTX) in patients with active rheumatoid arthritis (RA).Methods. MTX-naive patients with active RA (Disease Activity Score in 28 joints >4) were eligible for the study if they had not previously taken biologic agents and had not taken disease-modifying antirheumatic drugs for 2 weeks prior to randomization. Patients were randomly assigned to receive 15 mg/week of MTX either orally (2 7.5-mg tablets plus a dummy prefilled syringe; n ‫؍‬ 187 patients) or SC (prefilled syringe containing 10 mg/ml plus 2 dummy tablets; n ‫؍‬ 188 patients) for 24 weeks. At week 16, patients who did not meet the American College of Rheumatology criteria for 20% improvement (ACR20) were switched from 15 mg of oral MTX to 15 mg of SC MTX and from 15 mg of SC MTX to 20 mg of SC MTX for the remaining 8 weeks, still in a blinded manner. The primary outcome was an ACR20 response at 24 weeks.Results. At week 24, significantly more patients treated with SC MTX than with oral MTX showed ACR20 (78% versus 70%) and ACR70 (41% versus 33%) responses. Patients with a disease duration >12 months had even higher ACR20 response rates (89% for SC administration and 63% for oral). In 52 of the ACR20 nonresponders (14%), treatment was switched at week 16. Changing from oral to SC MTX and from 15 mg to 20 mg of SC MTX resulted in 30% and 23% ACR20 response rates, respectively, in these patients. MTX was well tolerated. The rate of adverse events was similar in all groups. Conclusion. This 6-month prospective, randomized, controlled trial is the first to examine oral versus SC administration of MTX. We found that SC administration was significantly more effective than oral administration of the same MTX dosage. There was no difference in tolerability.

BackgroundPatients with type 1 diabetes mellitus (DM1) have to be active participants in their treatment because they are inevitably responsible for their own day-to-day-care. Availability of mobile Internet access is advancing rapidly and mobile phones are now widely available at low cost. Thus, mobile phones have the potential to assist in daily diabetes management and to enable a telemedical interaction between patients and health care professionals.ObjectiveThe aim of the study was to evaluate the feasibility and user acceptance of a mobile phone–based data service to assist DM1 patients on intensive insulin treatment.MethodsA software application called Diab-Memory (based on Java 2 Mobile Edition) has been developed to support patients when entering diabetes-related data with synchronization to the remote database at the monitoring center. The data were then processed to generate statistics and trends, which were provided for the patient and his/her health care professional via a Web portal. The system has been evaluated in the course of a clinical before-after pilot trial. Outcome measures focused on patients’ adherence to the therapy, availability of the monitoring system, and the effects on metabolic status. General user acceptance of the system was evaluated using a questionnaire.ResultsTen patients (four female) with DM1 participated in the trial. Mean age was 36.6 years (± 11.0 years) and prestudy glycated hemoglobin (HbA1c) was 7.9% (± 1.1%). A total of 3850 log-ins were registered during the 3 months of the study. The total number of received datasets was 13003, which equates to an average of 14 transmitted parameters per patient per day. The service was well accepted by the patients (no dropouts), and data transmission via mobile phone was successful on the first attempt in 96.5% of cases. Upon completion of the study, a statistically significant improvement in metabolic control was observed (HbA1c: prestudy 7.9% ± 1.1% versus poststudy 7.5% ± 0.9%;P= .02). While there was a slight decrease in average blood glucose level (prestudy 141.8 mg/dL ± 22.5 mg/dL vs poststudy 141.2 mg/dL ± 23.1 mg/dL;P= .69), the difference was not statistically significant.ConclusionThe results of the clinical pilot trial indicate that this proposed diabetes management system was well accepted by the patients and practical for daily usage. Thus, using the mobile phone as patient terminal seems to provide a ubiquitous, easy-to-use, and cost efficient solution for patient-centered data acquisition in the management of DM1. To confirm the promising results of the pilot trial further research has to be done to study long-term effects on glycemic control and cost-effectiveness.

We tested the reliability, acceptability and feasibility of a home-monitoring system for cardiac patients. Each participant was equipped with a mobile phone, an automatic blood pressure device and a digital weight scale. In total, 20 patients (14 patients with chronic heart failure, six patients with hypertension; mean age 50 years, standard deviation [SD] 14) were monitored for 90 days each. They were asked to measure their blood pressure, pulse and body weight every day, and to transfer the data together with the dosage of medication to the telemonitoring server using wireless Internet technology in the mobile phone. The physician in charge received email alerts when reported data fell outside pre-defined limits. The patients' compliance with the system was high. During a cumulative monitoring period of 1,735 days, there were 2,040 data transfer sessions, a mean of 102 per patient (SD 43). The mean percentage of successful data transfers was 83% (SD 22). The stability of the telemonitoring system was 98%, meaning that patient data transfer was almost always possible. The accessibility of the secure web server for physicians was above 99%. The web-based home-monitoring system was reliable and easy to handle for both patients and health care professionals. It may be a useful tool for patients with heart failure as well as hypertensive patients.

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Patients with psoriasis who are being treated with biologics require intensive monitoring. However, the monitoring tool teledermatology is not commonly used. We investigated the applicability of a mobile phone based teledermatological system for monitoring psoriasis patients on biologic therapy. Nineteen patients were given mobile phones with built-in cameras, in order to transmit health status data and images (mobile visits) weekly for a 6-month period. Face-to-face visits were carried out at weeks 0, 4, 12 and 24. Image quality, the Psoriasis Area and Severity Index (PASI), the handling of adverse events, and patients' feedback questionnaires were evaluated. Ninety-five percent of the images were of sufficient quality to enable accurate assessment of the PASI. The distance between the interpolated face-to-face PASIs and the corresponding mobile visit PASIs was 0.46 ± 2.15 (median ± interquartile range). All 155 adverse events were handled correctly by the system. This teledermatological system represents a reliable tool for management of psoriasis patients who are on systemic treatment.

PurposeThis multicenter, randomized, crossover study compared preference, ease of use, acceptability, satisfaction, and safety of repeated subcutaneous (SC) self-administrations with prefilled pens and prefilled syringes delivering methotrexate (MTX), in patients with rheumatoid arthritis (RA).Patients and methodsThe study (ClinicalTrials.gov number NCT01793259) enrolled 120 patients requiring initiation or intensification of MTX therapy for RA. Patients were randomized to receive the test drug, a prefilled pen (Metex® PEN/Metoject® PEN), or the reference drug, a prefilled syringe (Metex®/Metoject®), at doses of 15, 17.5, or 20 mg MTX SC once a week for 3 weeks. This was followed by receipt of the reference drug (prefilled syringe) or the test drug (prefilled pen) in a crossover design, with each patient serving as his/her own control. Questionnaires regarding patient preference, the Self-Injection Assessment Questionnaire (SIAQ), and diaries regarding local tolerability were used to document outcomes.ResultsOverall patient preference for the MTX prefilled pen was 75% (P<0.0001). In a six-item questionnaire, 73% to 76% of the patients preferred the prefilled pen in relation to use, acceptability, and satisfaction, and 67% of the patients confirmed that it did not take much effort to overcome SC self-injection with the pen. The SIAQ showed no clinical differences, in any domain scores, between both devices. Overall patient attitude towards self-injection at baseline was positive, as was patient experience with both devices during the study. As well, 92% of physicians and study nurses indicated that they would recommend the MTX prefilled pen to patients for future MTX treatment. The formulations were generally well tolerated.ConclusionSC self-injection of MTX with a prefilled pen was generally preferred, by patients with RA, over a prefilled syringe with regard to use, acceptability, and satisfaction. This is supported by the strong appreciation of their attending study nurses and physicians, for its convenience.

BackgroundTelemonitoring services could dramatically improve the care of diabetes patients by enhancing their quality of life while decreasing healthcare expenditures. However, the potential for implementing innovative treatment options in the Austrian public and private health system is not known yet. Thus, we analyzed the readiness to use telemonitoring in diabetes care among Austrian practitioners.MethodsWe conducted an online survey among a purposive sample of Austrian practitioners (n = 41) using an adapted German version of the practitioner telehealth readiness assessment tool. We assessed three readiness domains for telemonitoring in the context of diabetes care, i.e. core readiness, engagement readiness, and structural readiness, and validated the German tool using principal components analysis.ResultsStudy subjects perceived themselves as open to innovations and also expressed optimistic attitudes towards telemonitoring in general and offering telemonitoring-based services for their patients. Participants achieved a medium average readiness level for telemonitoring (58.2, 95% CI 53.9–62.5) and were thus in a good position to use telemonitoring, although some arguments may adversely affected its use. The top three perceived benefits of telemonitoring were enhanced quality of treatment, better therapy adjustment, and reduced travel and waiting times for patients. The top three barriers were reduced personal communication, practitioner time expenditure and equally placed poor financial compensation as well as data security and privacy issues.ConclusionOur data revealed that Austrian practitioners showed a quite moderate readiness to use telemonitoring in diabetes care. To further advance telemonitoring readiness among all pillars of diabetes care in Austria, joint efforts among healthcare stakeholders are required to overcome existing financial, organizational, and technical obstacles.