The evaluation in real-life settings of services for the follow-up and control of hypertensive patients is a complex intervention, which still needs analysis of the roles, tasks, and resources involved in the basic items: patient, healthcare professional, and the interaction between the two. To evaluate the impact of patient-general practitioner (GP) short-messages-based interaction, isolated from other items, on the degree of hypertension control in the follow-up of medium-to-low-risk patients in primary care, a randomized controlled trial has been performed: 38 GPs enrolled 285 hypertensive patients who recorded the results of self-blood-pressure (BP) monitoring, heart rate, and body weight, and completed an optional questionnaire in an identical manner over a six-month period. The telemedicine group (TmG) sent the data to a telemedicine-based system that enabled patient-GP interaction; the control group (CG) recorded the data on paper and could only deliver it to their GP personally in the routine visits. In the TmG, the results were better, but not significantly so, for: 1) degree of hypertension control, in terms of the percentage of uncontrolled hypertensives at the final visit (TmG versus CG: 31.7% versus 35.6%; p = 0.47); 2) reduction in hypertension during follow-up, comparing measurements (performed by a professional) at the initial and final visits of systolic BP (15.5 versus 11.9; p = 0.13) and diastolic BP (9.6 versus 4.4; p = 0.40); and 3) adherence to the protocol within compliance levels of interest in a real-life follow-up service: >>50% (84.8% versus 73.3%) and >>25% (92.4.8% versus 75.4%) ( p = 0.053). Other factors such as average values of self-measured systolic BP, diastolic BP and heart rate, acceptability of the protocol, and median number of consultations and hospital admissions were similar in both groups. Outcomes show that, taken alone, the patient-GP short-messages-based interaction has very little impact on the degree of hypertension control in patients with this profile. In complex interventions, to discriminate the impact of each of its components in isolation will enable us to design an efficient follow-up service, little demanding in terms of healthcare professional dedication, and optimized in other basic aspects.
A platform built around three information entities (patient, health-care_agent, and central_station) was designed to enable patients with chronic heart disease (in stable condition; emergency situations were excluded deliberately) to complete specifically defined protocols for out-of-hospital follow-up and monitoring. The patients belonged to one of four specific risk groups: arterial hypertension, malignant arrhythmias, heart failure, and postinfarction rehabilitation. They were provided with portable recording equipment and a cellular phone that supported data transmission [electrocardiogram (ECG)] and wireless application protocol (WAP) (remaining parameters and ad hoc questionnaires). The central station was an automatized platform, with no human operator. The information received was organized chronologically in patient folders. The health-care_agents had continuous and secure access to the patient folders, through tools based on the world wide web and WAP, and to short messages sent by their patients. A pilot project was conducted with 89 patients (mean length of participation: 50.1 days). A total of 2168 ECGs (mean duration transmission = 2 min/30 s; network errors < 0.1%) and 4011 short messages (none lost, in 95% of cases 30 s < delay < 1 min) were transmitted; 6083 WAP sessions (mean duration = 3 min 11 s; network failures < 0.1%) were The functionality of the platform was also evaluated, analyzing the subjective component of usability, showing the evolution of patient acceptance over time.
The authors have designed and developed a telemedicine-based service for the follow-up and monitoring of patients on oral anticoagulant therapy (OAT) that consists of two phases; the first involving self-testing and the second involving guided self-management. To evaluate the first phase of the protocol, a project was conducted with 108 patients, with a mean age of 72.7 years and a mean treatment time at the start of the study of 55.2 months, divided into two groups: telemedicine and control (conventional procedure). The degree of anticoagulation control was similar in the two groups: individual in-range international normalized ratios (59.2% vs 61.1%; p = 0.55) and individual time within target range (65.7% vs 66.4%; p = 0.85) showed no significant differences. The incidence of adverse events--death (5.5% vs 5.5%; p = 1.0), major hemorrhagic complications (0% vs 1.8%; p = 1.0), minor hemorrhagic complications (7.4% vs 3.7%; p = 0.67), and thromboembolism (1.8% vs 3.7%; p = 1.0)--was also similar, with no significant differences. Acceptability of the change, measured in terms of quality of life (SF-12 and Sawicki questionnaires) and anxiety (state-trait anxiety inventory questionnaire) at the beginning and end of the study period was higher in the telemedicine group, with statistically significant improvements in mental component summary (3.6 vs -6.2; p = 0.02), dissatisfaction (-0.8 vs 0.2; p = 0.001), stress (-0.3 vs 0.05; p = 0.03), limitations (-0.2 vs 0.3; p = 0.005), social problems (-0.1 vs 0.3; p = 0.03), and state anxiety (-2.5 vs 2.3; p = 0.04). Parameters related to costs, such as the mean number per patient of office visits due to OAT (1.7 vs 13.8; p << 0.001) and other office visits (10.1 vs 11.5; p = 0.028), were also more favorable in the telemedicine group, as were additional parameters that enabled an exhaustive evaluation of the service. The positive results obtained indicate that the second phase of the trial can be initiated.
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