search
Back to results

Monitoring of Symptoms and Cognitive Function Using Telehealth

Primary Purpose

End Stage Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Liver Disease focused on measuring Telehealth, Quality of Life

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Einstein Healthcare Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient Satisfaction
Number of Participants reporting Satisfaction with Device

Secondary Outcome Measures

Full Information

First Posted
March 30, 2017
Last Updated
April 8, 2020
Sponsor
Albert Einstein Healthcare Network
search

1. Study Identification

Unique Protocol Identification Number
NCT03184701
Brief Title
Monitoring of Symptoms and Cognitive Function Using Telehealth
Official Title
Remote Monitoring of Symptoms and Cognitive Function Using Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2016 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
Keywords
Telehealth, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telehealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Number of Participants reporting Satisfaction with Device
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Navarro, MD
Organizational Affiliation
Einstein Healthcare network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Monitoring of Symptoms and Cognitive Function Using Telehealth

We'll reach out to this number within 24 hrs