CirrhoCare in COVID-19: A Pilot, Remote, Home Monitoring Study in Advanced Cirrhosis

NCT05045924 | Unknown

• 1 other identifier: CirrhoCare
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 outbreak has exposed many strengths and weaknesses of delivering healthcare, and we want to assess whether patients with advanced liver cirrhosis can be effectively monitored at home, to limit hospital visits and thereby their infection risks. We also wish to show that if they have new signs of clinical deterioration, that these can be picked up quickly even in the community, and can result in early review or appropriate treatment. This study has been funded by INNOVATE UK, who are seeking novel ways and technologies to improve health during the pressures of the COVID pandemic. Taking part in this study involves a consultation with the investigating doctor and being shown how to use a phone-based App and the supplied CirrhoCare equipment (Withings Watch, scales, and Blood Pressure cuff). Patients will be shown how to use the equipment for several simple daily assessments, including: Heart rate (ECG) readings via the supplied Withings Watch. This would take approximately 7-10 minutes to perform each day. Daily weight, using a special weighing scale that also measures the amount of body water and muscle percentages (takes 30 seconds to perform). Digital blood pressure measurement, using the supplied cuff. This would take approximately 2 minutes to perform daily. For all the above measurements, that are entirely automated, the patient will be guided via the mobile phone App with step-by-step video instructions. In addition, they will be given printed instructions. Individuals will be asked to perform the measurements through daily prompts built into the App, and be sent reminders, in case they forget. If they have difficulties with any of the tasks, there is also an App based support system, where they can send a message for the trial team to provide assistance. In addition to the measurements above, patients will be prompted to click on a memory testing exercise of naming animals (termed - 'Stroop test'), which will be performed after the daily morning measurements. This can take half a minute to up to four minutes to perform, depending on an individual's memory function. The equipment will be supplied will enable daily monitoring for a maximum of 3 months in this study. We will also be able to learn from the supplied watch, how much sleep and how much daily exercise patients get, which will help us assess general physical well-being. Furthermore, patients will be aksed to supply information on the amount of fluid and food they have consumed via simple 'click' functions on the App (e.g. clicking next to the picture denoting 4 glasses of water). Patients will be prompted to do this via smartphone and watch every evening. We will seek patient feedback on using the App through a brief in-App based questionnaire, after 4, 8 and 12 weeks of study. In addition, patients will fill in a quality of life questionnaire before they start using the equipment, and then again after 4 weeks and 12 weeks. These brief questionnaires are through simple drop-down menus on the App and take less than 5 minutes to complete. At the end of 12 weeks, or if individuals leave the study earlier, all the equipment will be returned to the investigating team, to analyse the data. In addition to the data that we will collect from the digital tools described above, we will also access routine blood tests performed when determined necessary by the liver doctors, as part of the standard of care.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Feasibility and usability of remote monitoring devices

  Feasibility and usability of the remote monitoring devices and App will be determined by questionnaires given to the participants at 1, 2 and 3 months of follow-up

  3 months

• Quality of life assessment

  A quality of life questionnaire assessed at the outset of the study, will be re-assessed at 1 and 3 months in addition to patient experience reported during direct physician interview. This pilot data will be compared to the prior experiences of these patients with telephone follow-up only (or/and hospital visits), during COVID-19.

  3 months

Secondary Outcomes (3)

• Complications of cirrhosis

  3 months

• Clinical scores of cirrhosis

  3 months

• Mortality

  6 months

Study Arms (2)

Intervention group

20 patients with decompensated liver cirrhosis monitored using a wrist-watch wearable device, with associated smart weighing scales and blood pressure cuff, along with a smartphone application (including economic smartphone in those patients if not available), to facilitate home monitoring.

Control group

20 patients with decompensated liver cirrhosis receiving standard quality of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified by the PI and/or clinical fellows on the study log, using existing clinic lists, and inpatient and discharge lists, containing identifiable personal information, that highlight those patients with decompensated cirrhosis, at risk of further decompensation and who will require regular telephone follow up under the Liver team. The PI and Clinical fellows would normally be reviewing these patients in a routine Out-patient clinic slot - currently by telephone appointments. In addition, patients ready to be discharged from hospital or/and attending day case paracentesis for ascites, will be identified by members of the normal clinical team, to schedule routine follow up.

You may qualify if:

• Men and women of age ≥ 18 years old.
• Child-Pugh A, B patients or Child-Pugh C patients (up to 12 points).
• Patients with a recent history of cirrhosis decompensation or/and recent discharge from the hospital for an episode of acute cirrhosis decompensation
• Participants able to give informed consent

You may not qualify if:

• Patients with ACLF according to the criteria published by Moreau et al, Gastro 2013
• Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification. 5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
• \. Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy.
• \. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.
• \. Patients with mental incapacity, language barrier, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
• Refusal or inability to give informed consent

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Innovate UK: collaborator

Study Sites (1)

Royal Free Hospital

London, NW32QG, United Kingdom

Location

Related Publications (5)

• Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437.e1-9. doi: 10.1053/j.gastro.2013.02.042. Epub 2013 Mar 6.

  PMID: 23474284 BACKGROUND

• Jalan R, Pavesi M, Saliba F, Amoros A, Fernandez J, Holland-Fischer P, Sawhney R, Mookerjee R, Caraceni P, Moreau R, Gines P, Durand F, Angeli P, Alessandria C, Laleman W, Trebicka J, Samuel D, Zeuzem S, Gustot T, Gerbes AL, Wendon J, Bernardi M, Arroyo V; CANONIC Study Investigators; EASL-CLIF Consortium. The CLIF Consortium Acute Decompensation score (CLIF-C ADs) for prognosis of hospitalised cirrhotic patients without acute-on-chronic liver failure. J Hepatol. 2015 Apr;62(4):831-40. doi: 10.1016/j.jhep.2014.11.012. Epub 2014 Nov 22.

  PMID: 25463539 BACKGROUND

• Morando F, Maresio G, Piano S, Fasolato S, Cavallin M, Romano A, Rosi S, Gola E, Frigo AC, Stanco M, Destro C, Rupolo G, Mantoan D, Gatta A, Angeli P. How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination by consultant hepatologists. J Hepatol. 2013 Aug;59(2):257-64. doi: 10.1016/j.jhep.2013.03.010. Epub 2013 Mar 21.

  PMID: 23523582 BACKGROUND

• Tapper EB, Asrani SK. The COVID-19 pandemic will have a long-lasting impact on the quality of cirrhosis care. J Hepatol. 2020 Aug;73(2):441-445. doi: 10.1016/j.jhep.2020.04.005. Epub 2020 Apr 13.

  PMID: 32298769 BACKGROUND

• Gananandan K, Thomas V, Woo WL, Boddu R, Kumar R, Raja M, Balaji A, Kazankov K, Mookerjee RP. Fat mass: a novel digital biomarker for remote monitoring that may indicate risk for malnutrition and new complications in decompensated cirrhosis. BMC Med Inform Decis Mak. 2023 Sep 13;23(1):180. doi: 10.1186/s12911-023-02288-z.

  PMID: 37705043 DERIVED

Study Officials

• Rajeshwar Mookerjee, MBBS, PhD

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 16, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

GB (1)