The new device collects some information automatically but also relies on patient reports of measures like well-being.
Digital therapeutics could provide an important early warning system to track potential complications in patients with cirrhosis following discharge from the hospital, according to a new report.
The study found people who used the cirrhosis digital therapeutic were less likely to be readmitted to the hospital when they used the app.
Cirrhosis is scarring of the liver caused by various forms of liver diseases. A build-up of scar tissue in the liver may mean there is less healthy liver tissue available to perform the many functions of the liver.
The digital therapeutic, which is being marketed under the name CirrhoCare, is designed for remote monitoring of cirrhosis patients, tracking data such as hemodynamic measurements, weight, water and alcohol intake, cognitive function, and well-being. By regularly measuring and reporting those metrics, the product’s developers hope clinicians can more quickly identify patients who warrant intervention or at risk of re-hospitalization.
Raj Mookerjee, M.B.B.S., Ph.D., of University College London, who recently evaluated the product in a proof-of-concept study published in the Journal of Hepatology, said there have been some previous efforts to use digital therapeutics to monitor cirrhosis patients, but those products have typically focused on just a single metric, rather than attempting to holistically monitor patients.
“CirrhoCare is the first multimodal monitoring system designed to assess the key complications of cirrhosis ‘decompensation’ events, and with proprietary algorithms, then present actionable insights derived from home monitoring to assist clinical decision making on interventions,” he told Managed Healthcare Executive®.
In the study, 20 patients with cirrhosis (most with alcoholic cirrhosis) were matched with 20 controls. After a follow-up of about 10 weeks, most patients (15) using CirrhoCare were engaging with the app at least four times per week. Patients using CirrhoCare had fewer readmissions, and those readmissions tended to come more quickly and last for a shorter period of time. Five of the patients had eight readmissions for a median of five days, but none required hospitalization for more than two weeks.
Clinicians made 16 contacts with patients as a result of CirrhoCare data, allowing them to make interventions that may have limited a patient’s deterioration. In the control group, there were 13 readmissions among eight patients, and four of those readmissions lasted more than 14 days. The control group had six unplanned paracenteses, while there was just one in the CirrhoCare group.
Mookerjee said was pleased with the high levels of engagement with the app, and he said the feedback from users was also helpful in fine-tuning the application.
“We were also delighted to see that we were able to detect new complications and, in many cases, prevent the requirement for direct hospital management, including draining abdominal fluid,” he said.
In the case of CirrhoCare, engagement matters not just because it is a sign that users are embracing the software; engagement is also required in order to get the full measure of a patient’s condition. While the biomarker measurements the app tracks can be automatically generated from monitoring devices linked to the CirrhoCare app, other metrics — such as food intake and well-being — require the user to input the data, and to do so accurately. Mookerjee said in the current study, they did not encounter significant problems with patients inaccurately tracking patient-monitored metrics. He said the inaccuracies that were reported were usually caught via clinician follow-up.
“Occasionally the fluid intake was inaccurate and was re-affirmed on clinical contact when incongruous with the digital biomarker outputs,” he said.
Speaking more broadly, Mookerjee said inaccurate patient reports are something that will need to be studied further, but he noted that a lack of accurate patient inputs is also a type of signal.
“Lack of reporting or/and performance of the digital biomarkers might in itself be a clinical sign, often indicating subtle brain dysfunction,” he said. “We are still in the early stages of inferring all the lessons to be learnt from the large amount of data collected in this proof-of-concept study.”
Going forward, Mookerjee said larger trials will be required to further validate the app and to see if the results of this study can be replicated. He said such studies are currently in the planning stages.