Objective:
To investigate the clinical feasibility (technical feasibility and patient-/clinician adherence) of remote telemonitoring, using a mobile phone, in an international and diverse HF population.
Methods:
HF patients from five centers in the USA, India and Sweden were equipped with a blood pressure apparatus, digital weight scale and a mobile phone device with custom made software for remote telemonitoring (Vitalbeat®). Patients were asked to record and transmit daily information on body weight, blood pressure and pulse rate as well as symptoms and adherence to medical therapy for 90 days. The primary endpoint, for assessment of general feasibility was defined as % of days with a combination of successful data transmission from patients and data read by clinicians. Acceptable clinical feasibility was a priori set as ≥ 66% of days meeting the primary endpoint. A survey was used to assess patients’ opinions about the remote monitoring system. Data was analyzed according to Intention to treat.
Results:
46 HF patients were included (India=20, USA=13, Sweden=13; 59±16yrs; 84% male; NYHA-class 2.4±0.8) and followed for a total of 4410 days. The primary endpoint occurred in 3178 days (77%) and 34/46 patients (74%) exceeded the cut-off ≥ 66% of days meeting endpoint criteria. In the majority of patients (n=28; 61 %) the primary endpoint was met ≥ 90% of the days, and in 6 patients (13%) 66-89% of the days.Twelve patients (26%) opted to drop out of the study prematurely or were hospitalized for HF related causes. Compared to patients with acceptable clinical feasibility (≥ 66%), patients with less than acceptable feasibility (< 66%) were older (72±12 vs. 56±15 yrs, p=0.003) and more likely to be followed at a center in USA or Sweden (p=0.02 vs. Indian centers). The monitoring system was described as user friendly by 91 % of patients.
Conclusion:
This study shows that remote telemonitoring using a mobile phone is clinically feasible in an international and diverse heart failure population. However, monitoring was less feasible in elderly patients and depended on the geographic location. Further studies are warranted to assess whether clinical feasibility can improve with improved software/hardware design and/or patient selection.
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