An integrated smartphone technology approach proved no better or worse than standard care for controlling hypertension following a heart attack in a single-center clinical trial.
Compared to patients who had regular in-person clinic visits, patients randomized to receive the smart technology monitoring with reduced clinic visits had similar rates of controlled blood pressure after 1 year.
Patient satisfaction and other clinical outcomes, including all-cause mortality, recurrent myocardial infarction (MI) and hospitalization for heart failure were also similar in the two groups.
The exploratory clinical trial showed the mobile health approach to be feasible and widely accepted by patients.
“To our knowledge this is the first trial to partially substitute physical outpatient clinic visits by e-visits in this patient population,” wrote researcher Roderick Treskes, PhD, of Leiden University Medical Center in The Netherlands, and colleagues, in JAMA Network Open.
The study included 200 patients (median age, 59.7 years) who had recently suffered an acute MI, with half randomized to receive the smart technology intervention and half receiving regular care, which consisted of 4 scheduled, in-person outpatient clinic visits 1, 3, 6 and 12-months following their cardiac event.
The intervention group received 4 smartphone-compatible devices (weight scale, blood pressure monitor, rhythm monitor and step counter), and they had 2 in-person scheduled clinic visits instead of 4 during the year-long study (months 3 and 12).
The outpatient clinic visits included an electrocardiogram (ECG), blood pressure measurement by a nurse practitioner, patient interviews, laboratory testing, a stress echocardiogram (performed at the 3 month visit), a 24-hour Holter monitoring procedure (performed at 3 and 6 months) and a transthoracic echocardiogram (performed at 6 and 12 months).
Patients in the intervention group were asked to record their steps continuously, their blood pressure and weight daily, and their ECG daily and to record symptoms potentially related to cardiac causes. These data were reviewed daily by a project trained healthcare professional, and patients were contacted when their systolic blood pressure exceeded 139 mmHg, their diastolic blood pressure exceeded 89 mmHg, or new signs of arrhythmia or at least 4 newly diagnosed symptomatic premature ventricular contractions on a single-lead ECG.
The primary outcome was blood pressure control and secondary outcomes included patient satisfaction with treatment, measurement adherence, all-cause mortality and hospitalization for nonfatal adverse cardiac events.
Among the main study findings:
- After 1 year, 79% of patients in the intervention arm had blood pressure that was under control versus 76% of patients in the control group (P=0.64).
- General satisfaction with care, measured using general questionnaire and smart-technology-specific questionnaires, was similar in both groups (mean [SD] 82.6 [14.1] in the intervention group vs. 82.0 [15.1]; P=0.88).
- All-cause mortality was 2% in both groups (P>0.99) and there were 8 hospitalizations for nonfatal cardiac causes in the intervention group and 12 in the control group.
- Among the intervention patients, 32% sent measurements weekly without missing a week, and 63% sent measurements more than 80% of all 52 weeks.
Among patients in the intervention group, 90% reported that they were satisfied with the smart technology interventions, with the exception of the step counter, which just 4% of patients reported being satisfied with. Almost all (96%) indicated that they appreciated being able to view their own health data.
“Electronic visits can reduce time and costs for patients and can lower overhead costs,” the researchers wrote. “Therefore, this trial adds to the existing literature that eHealth in the outpatient clinic can be a valuable add-on. However, more trials should be performed to establish the value of eHealth in the follow-up of patients with acute MI.”
In an accompanying editorial, Steven M. Bradley, MD, of Minneapolis Heart Institute, noted that patient acceptance of the smart technology intervention was high, with close to 73% of those randomized to the intervention arm agreeing to participate in the study.
“The high degree of overall acceptability and insights on barriers to participation inform the degree to which mobile health and resulting patient-generated data could offer a different approach to longitudinal health care for patients with chronic diseases,” Bradley wrote.
Bradley further noted that the generally high health data transmission rate “suggests that it is feasible to capture and transmit patient-generated data for a substantial proportion of patients with subsequent care delivery informed by data review.”
He wrote that with the aging of the population in the U.S., demand for health care visits is outpacing supply.
“An alternative model that leverages a combination of data from the patient’s electronic health record and routinely transmitted patient-generated data could obviate the need for many routinely scheduled visits.”
Bradley concluded that while there is not yet much data showing a health benefit associated with medical care delivered through smart technology, “this should not temper enthusiasm for the potential of mobile health and patient-generated data to address shortcomings in traditional health care delivery or for studies of how these tools might make health care better.”
Compared to MI patients who had regular in-person clinic visits, patients randomized to receive smart technology monitoring with reduced clinic visits had similar rates of controlled blood pressure after 1 year.
After 1 year, 79% of patients in the intervention arm had blood pressure that was under control versus 76% of patients in the control group (P=0.64).
Salynn Boyles, Contributing Writer, BreakingMED™
Researcher Roderick Treskes reported receiving personal fees from Boston Scientific unrelated to this research. The Department of Cardiology at Leiden University Medical Center also received unrestricted research and educational grants from Boston Scientific, Medtronic, and Biotronik outside the submitted work.
Cat ID: 102
Topic ID: 74,102,730,102,358,192,925
Treskes RW, et al “Effect of smartphone-enabled health monitoring devices vs regular follow-up on blood pressure control among patients after myocardial infarction” JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.2165.
Bradley SM “Use of mobile health and patient-generated data — making health care better by making health care different” JAMA Network Open 2020; DOI: 10.1001/jamanetworkopen.2020.2971.