End Stage Liver DiseaseNCT03184701
Monitoring of Symptoms and Cognitive Function Using Telehealth
A study testing Telehealth in people with End Stage Liver Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2016to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End Stage Liver Disease with at least 1 or more complications (Hepatorenal Syndrome, Portal Hypertension, Ascites, Hepatic Encephalopathy)
Who cannot join
- Cognitive impairment
- Current psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
Official title: 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
Read the 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.
- Conditions
- End Stage Liver Disease
- Being tested
- Telehealth
- Keywords
- Telehealth, Quality of Life
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Number of Participants reporting Satisfaction with Device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start30 Apr 2016
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Navarro, Albert Einstein Healthcare Network
- Investigators
- Victor Navarro, MD, Principal investigator, Einstein Healthcare network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184701
- Sponsor's protocol ID
- HN4828
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2017
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Symptoms and Cognitive Function Using Telehealth
- ClinicalTrials.gov ID
- NCT03184701
- Acronym / sponsor ID
- HN4828
- Conditions
- End Stage Liver Disease
- Keywords
- Telehealth, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: TelehealthPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End Stage Liver Disease with at least 1 or more complications (Hepatorenal Syndrome, Portal Hypertension, Ascites, Hepatic Encephalopathy)
Key exclusion criteria (2 listed)
- Cognitive impairment
- Current psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelehealthPatients 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. | Other | Experimental |
Primary outcome
Patient Satisfaction
Time frame: 3 months
Number of Participants reporting Satisfaction with Device
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver Disease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Navarro, MD principal investigator
Einstein Healthcare network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in people with End Stage Liver Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.