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

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

Sponsors & Collaborators

• Innovate UK

  collaborator OTHER_GOV

• Royal Free Hospital NHS Foundation Trust

  lead OTHER

Principal Investigators

• Rajeshwar Mookerjee, MBBS, PhD · Royal Free Hospital NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• United Kingdom

Study Locations