Monitoring of Symptoms and Cognitive Function Using Telehealth

Not Applicable

Completed

• Conditions: End Stage Liver Disease
• Interventions: Other: Telehealth

• Registration Number: NCT03184701
• Lead Sponsor: Albert Einstein Healthcare Network

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.

Study Timeline

• Study Start: 2016-04-30
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-06-10
• Study First Posted: 2017-06-14
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Results First Submitted: 2018-12-28
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-08
• Last Update Submitted: 2020-04-08
• Results First Posted: 2020-04-17
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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Exclusion Criteria

• Cognitive impairment
• Current psychosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Telehealth	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.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	3 months	Number of Participants reporting Satisfaction with Device

Trial Locations

Locations (1)

Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States