Monitoring of Symptoms and Cognitive Function Using Telehealth

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT03184701
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 28
• Patients Per Site Per Month: 1.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver Disease	Other: Telehealth	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Remote Monitoring of Symptoms and Cognitive Function Using Telehealth
• Actual Study Start Date: Apr 30, 2016
• Actual Primary Completion Date: Aug 30, 2018
• Actual Study Completion Date: Aug 30, 2018

Arms and Interventions

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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction [3 months]

   Number of Participants reporting Satisfaction with Device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Einstein Healthcare Network	Philadelphia	Pennsylvania	United States	19141

Sponsors and Collaborators

• Albert Einstein Healthcare Network

Investigators

• Principal Investigator: Victor Navarro, MD, Einstein Healthcare network

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2017

More Information

Publications

None provided.

• Responsible Party: Victor Navarro, Chairman, Hepatology, Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT03184701
• Other Study ID Numbers: HN4828
• First Posted: Jun 14, 2017
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Victor Navarro, Chairman, Hepatology, Albert Einstein Healthcare Network: Telehealth; Quality of Life
• Additional relevant MeSH terms: Liver Diseases; End Stage Liver Disease

Study Results

Participant Flow

Arm/Group Title	Intervention Arm
Arm/Group Description	All study participants were included in this intervention arm, and given a device with questions to respond.
Period Title: Overall Study
STARTED	45
COMPLETED	28
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Experimental
Arm/Group 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. 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.
Overall Participants	45
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55.7
Sex: Female, Male (Count of Participants)
Female	24 53.3%
Male	21 46.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 4.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 20%
White	30 66.7%
More than one race	0 0%
Unknown or Not Reported	4 8.9%

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction
Description	Number of Participants reporting Satisfaction with Device
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

All participants who completed the end of study survey (at 3 months) are included.

Arm/Group Title	Intervention Arm
Arm/Group Description	All study participants were included in this intervention arm, and given a device with questions to respond.
Measure Participants	45
Count of Participants [Participants]	45 100%

2. Post-Hoc Outcome

Title	Hospital Readmissions at 30 Days
Description	Number of admissions to the hospital
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events were collected during the study participation (3 months)
Arm/Group Title	Experimental
Arm/Group 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. 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.
All Cause Mortality
	Experimental
	Affected / at Risk (%)	# Events
Total	3/45 (6.7%)
Serious Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.