TY - JOUR

T1 - Evaluation of CirrhoCare® – a digital health solution for home management of individuals with cirrhosis

AU - Kazankov, Konstantin

AU - Novelli, Simone

AU - Chatterjee, Devnandan A

AU - Phillips, Alexandra

AU - Balaji, Anu

AU - Raja, Maruthi

AU - Foster, Graham

AU - Tripathi, Dhiraj

AU - Boddu, Ravan

AU - Kumar, Ravi

AU - Jalan, Rajiv

AU - Mookerjee, Rajeshwar P

PY - 2023/1

Y1 - 2023/1

N2 - BACKGROUND: Cirrhosis patients discharged from hospital following acute decompensation are at high-risk of new complications. This study aimed to assess the feasibility and potential clinical benefits of remote management of acutely decompensated cirrhosis patients using CirrhoCare®.METHODS: Cirrhosis patients with acute decompensation were followed with CirrhoCare® and compared with contemporaneous matched controls, managed with standard follow-up. Commercially available monitoring devices were linked to the smartphone CirrhoCare®-App, for daily recording of heart rate, blood pressure, weight, % body-water, cognitive function [CL-Animal Recognition Test (CL-ART) App], self-reported well-being and, intake of food, fluid and alcohol. The App had 2-way patient-physician communication. Independent external adjudicators assessed appropriateness of CirrhoCare-based decisions.RESULTS: Twenty-cirrhotic patients were recruited to CirrhoCare® (mean age 59±10 years, 14-male, alcoholic cirrhosis (80%), mean MELD-Na score 16.1±4.2) and were not statistically different to twenty contemporaneous controls. Follow up was 10.1±2.4 weeks. Fifteen-patients showed good engagement (≥4 readings/week), 2 moderate (2-3/week), and 3 poor (<2/week). In a usability questionnaire the median score was ≥9 for all questions. Five CirrhoCare®-managed patients had 8-readmissions over median of 5 (IQR 3.5-11) days, and none required hospitalization for >14 days. Sixteen other CirrhoCare-guided patient contacts were made, leading to clinical interventions that prevented further progression. Appropriateness was confirmed by adjudicators. Controls had 13-readmissions in 8-patients, lasting median 7 (IQR 3-15) days with 4-admissions of >14 days. They had 6 unplanned paracenteses compared to 1 in the CirrhoCare® group.CONCLUSIONS: This study demonstrates CirrhoCare® is feasible for community management of decompensated cirrhosis patients with good engagement and clinically-relevant alerts to new decompensating events. CirrhoCare® managed patients have fewer and shorter readmissions justifying confirmatory larger controlled clinical trials.LAY SUMMARY: This first study of digital, real-time, home management for multiple complications of advanced cirrhosis, with CirrhoCare®, showed positive patient engagement and feedback in patients with mainly alcohol-related cirrhosis, following a recent hospital discharge. CirrhoCare® allowed early diagnosis of new complications for patients at home, prompting their hepatologists to intervene over >10 weeks follow-up. CirrhoCare® managed patients had fewer and shorter hospital readmissions, as well as less unplanned abdominal fluid drains than in a control group. CirrhoCare® is a promising tool for specialist, community management of cirrhosis patients, at-risk of new cirrhosis complications.

AB - BACKGROUND: Cirrhosis patients discharged from hospital following acute decompensation are at high-risk of new complications. This study aimed to assess the feasibility and potential clinical benefits of remote management of acutely decompensated cirrhosis patients using CirrhoCare®.METHODS: Cirrhosis patients with acute decompensation were followed with CirrhoCare® and compared with contemporaneous matched controls, managed with standard follow-up. Commercially available monitoring devices were linked to the smartphone CirrhoCare®-App, for daily recording of heart rate, blood pressure, weight, % body-water, cognitive function [CL-Animal Recognition Test (CL-ART) App], self-reported well-being and, intake of food, fluid and alcohol. The App had 2-way patient-physician communication. Independent external adjudicators assessed appropriateness of CirrhoCare-based decisions.RESULTS: Twenty-cirrhotic patients were recruited to CirrhoCare® (mean age 59±10 years, 14-male, alcoholic cirrhosis (80%), mean MELD-Na score 16.1±4.2) and were not statistically different to twenty contemporaneous controls. Follow up was 10.1±2.4 weeks. Fifteen-patients showed good engagement (≥4 readings/week), 2 moderate (2-3/week), and 3 poor (<2/week). In a usability questionnaire the median score was ≥9 for all questions. Five CirrhoCare®-managed patients had 8-readmissions over median of 5 (IQR 3.5-11) days, and none required hospitalization for >14 days. Sixteen other CirrhoCare-guided patient contacts were made, leading to clinical interventions that prevented further progression. Appropriateness was confirmed by adjudicators. Controls had 13-readmissions in 8-patients, lasting median 7 (IQR 3-15) days with 4-admissions of >14 days. They had 6 unplanned paracenteses compared to 1 in the CirrhoCare® group.CONCLUSIONS: This study demonstrates CirrhoCare® is feasible for community management of decompensated cirrhosis patients with good engagement and clinically-relevant alerts to new decompensating events. CirrhoCare® managed patients have fewer and shorter readmissions justifying confirmatory larger controlled clinical trials.LAY SUMMARY: This first study of digital, real-time, home management for multiple complications of advanced cirrhosis, with CirrhoCare®, showed positive patient engagement and feedback in patients with mainly alcohol-related cirrhosis, following a recent hospital discharge. CirrhoCare® allowed early diagnosis of new complications for patients at home, prompting their hepatologists to intervene over >10 weeks follow-up. CirrhoCare® managed patients had fewer and shorter hospital readmissions, as well as less unplanned abdominal fluid drains than in a control group. CirrhoCare® is a promising tool for specialist, community management of cirrhosis patients, at-risk of new cirrhosis complications.

KW - Decompensation

KW - Liver disease

KW - Remote management

U2 - 10.1016/j.jhep.2022.08.034

DO - 10.1016/j.jhep.2022.08.034

M3 - Journal article

C2 - 36087864

VL - 78

SP - 123

EP - 132

JO - Journal of Hepatology

JF - Journal of Hepatology

SN - 0168-8278

IS - 1

ER -