Monitoring of Symptoms and Cognitive Function Using Telehealth

NCT03184701 | Completed Results

• 1 other identifier: HN4828
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Liver Disease

Keywords

Telehealth; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Number of Participants reporting Satisfaction with Device

  3 months

Study Arms (1)

Experimental

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.

Other: Telehealth

Interventions

Telehealth 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.

Experimental

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment
• Current psychosis

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Manisha Verma
• Organization: Albert Einstein Healthcare Netwrok

vermam@einstein.edu

2154561026

Study Officials

• Victor Navarro, MD

  Einstein Healthcare network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Hepatology

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: June 14, 2017
• Study Start: April 30, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: April 17, 2020
• Results First Posted: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)