Monitoring of Symptoms and Cognitive Function Using Telehealth

NCT ID: NCT03184701

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-08-30

Brief Summary

End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked by episodic acute exacerbations of the underlying liver disease which often leads to severe symptoms, poor quality of life, mental deterioration and repeated hospitalizations.

The overall purpose of this project is to introduce a telehealth based intervention (involving remote monitoring of symptoms and cognitive function initiated at the time of discharge of ESLD patients. This will support enhanced clinical care and improve self-management in ESLD population. In addition, it will reduce healthcare utilization, improve medication adherence and overall health outcomes

Detailed Description

This is a single arm study to assess the effectiveness of an experimental telehealth intervention within the treatment of ESLD, and compare it with a historic cohort. All inpatients with advanced liver disease and at least 1 complication will be eligible to participate. the study group receives the Telehealth intervention and will be given an ipad preloaded with the instruments used for symptom monitoring and cognitive function assessment during the hospital admission.

Conditions

End Stage Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental

Patients assigned to this arm receive the intervention in addition to routine standard of care. Telehealth based remote monitoring of symptoms and brain tests is the intervention in this study. A device with preloaded questionaires will be given to patients randomized to this group. The patients will respond on a daily basis for the 3 months of intervention phase.

Group Type: EXPERIMENTAL

Telehealth

Intervention Type: OTHER

Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach.

Interventions

Telehealth

Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• End Stage Liver Disease with at least 1 or more complications (Hepatorenal Syndrome, Portal Hypertension, Ascites, Hepatic Encephalopathy)

Exclusion Criteria

• Cognitive impairment
• Current psychosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Victor Navarro

Chairman, Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Einstein Healthcare network

Locations

Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HN4828

Identifier Type: -

Identifier Source: org_study_id