- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184701
Monitoring of Symptoms and Cognitive Function Using Telehealth
Remote Monitoring of Symptoms and Cognitive Function Using Telehealth
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Einstein Healthcare Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction
Time Frame: 3 months
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Number of Participants reporting Satisfaction with Device
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Victor Navarro, MD, Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN4828
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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