Cirrhosis, LiverNCT03969186
Telehealth Intervention in Cirrhotics
A study testing Intervention in people with Cirrhosis, Liver and Liver Diseases, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is a randomized controlled trial comparing a simple telehealth intervention implemented after hospital discharge to standard of care, specifically looking at the number of hospital readmissions throughout the course of the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Liver, Liver Diseases
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cirrhosis of the liver
- Admitted to the Hospital of the University of Pennsylvania
- Ability to read and provide informed consent in English
- Ability to read and provide informed consent or surrogate present who can provide consent
- Possess a cell phone and willing to receive text messages.
- Has a surrogate who with a cell phone who is willing to receive and sent text messages for patient
Who cannot join
- Inability to provide informed consent in English
- Inability to provide informed consent or lack of surrogate who can provide consent
- Non-Cirrhotic
- Has received a liver transplant
- Discharged to hospice or has a disease process other than cirrhosis (i.e. severe heart disease or cancer) accounting for a high chance of mortality in the next 6 months.
- Advance symptoms of other disease process or too medically complex
Show all 9Show fewer
- Actively using illicit substances or alcohol
- No access to cell phone with texting capability
- Not followed at the Hospital of the University of Pennsylvania
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial
This study is a randomized controlled trial comparing a simple telehealth intervention implemented after hospital discharge to standard of care, specifically looking at the number of hospital readmissions throughout the course of the study. All cirrhotic patients admitted to the Hepatology service at The Hospital of the University of Pennsylvania will be approached and consenting patients will be randomized to one of the two arms as outlined below. Patients will be followed for 90 days with daily texts and weekly phone calls. The rates of 30 and 90 day readmission as well as the days to readmission will be compared between the two study groups.
Read the detailed description
Patients with cirrhosis and ascites comprise a large percentage of hospital admissions. As a large transplant center, the University of Pennsylvania sees an average of 54-65 cirrhotic patients admitted to the hepatology service every month. Many of these admissions are preventable and can be attributed to poor medication adherence and late detection of clinical deterioration. By introducing a telehealth intervention following hospital discharge, investigators seek to decrease the number of readmissions for these patients by encouraging and assisting with improved adherence and by regularly tracking the progression of symptoms.
This interventional study will serve a dual purpose of helping both the patient and their provider. Patients will obtain an extra line of communication to their providers that eases their ability to access resources and alert their providers to new symptoms. Similarly, by instituting a triaged system of communication with the patient, their health team is able to offer more individualized treatment while also providing more immediate attention at the first signs of clinical deterioration. This study will determine rates of 30 and 90-day readmissions in both cohorts as a way to examine the impact of a simple telehealth intervention compared to standard of care.
- Conditions
- Cirrhosis, Liver, Liver Diseases
- Being tested
- Intervention
- Keywords
- Telehealth, Cirrhosis, Ascites, Hepatic encephalopathy, Readmissions, Preventable readmissions, Liver diseases, Variceal bleeding
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Fibrosis, Ascites, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Daily telehealth follow-up | Experimental | The intervention arm will receive a simple telehealth intervention utilizing the Way to Health Platform engineered at the University of Pennsylvania. This platform will be used to send daily SMS messages to patients for 90 days following discharge and alert the research team to changes in patients' status. In addition, the patients in the intervention arm will receive a weekly phone call administered by members of the research team to assess their overall progress and well-being. Receives: Behavioral: Intervention |
| Standard of care follow-up | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in readmission rates of cirrhotic patients
Number of hospital readmissions during the 90 day intervention compared to control arm
Measured: 90 Days
Secondary outcomes (1)
A difference in patient or caregiver satisfaction post-discharge.
Self-reported patient satisfaction in surveys at 30 and 90 days looking at the research team's effectiveness, as well as provider communication. Satisfaction will be scored on a sliding scale and statistically analyzed to provide a quantifiable difference in satisfaction post-discharge for patients based on several aspects of their care.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start11 Oct 2017
- Primary completion26 Jun 2020
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vandana Khungar, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969186
- Sponsor's protocol ID
- 828183
- Other IDs
- chbgaidc
- Status last verified
- Mar 2024
- First submitted
- 22 May 2019
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of A Telehealth Intervention to Decrease Readmissions in Cirrhosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03969186
- Acronym / sponsor ID
- 828183
- Conditions
- Cirrhosis, Liver, Liver Diseases
- Keywords
- Telehealth, Cirrhosis, Ascites, Hepatic encephalopathy, Readmissions, Preventable readmissions, Liver diseases, Variceal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial comparing a simple telehealth intervention implemented after hospital discharge to standard of care, specifically looking at the number of hospital readmissions throughout the course of the study. All cirrhotic patients admitted to the Hepatology service at The Hospital of the University of Pennsylvania will be approached and consenting patients will be randomized to one of the two arms as outlined below. Patients will be followed for 90 days with daily texts and weekly phone calls. The rates of 30 and 90 day readmission as well as the days to readmission will be compared between the two study groups.
Detailed description
Patients with cirrhosis and ascites comprise a large percentage of hospital admissions. As a large transplant center, the University of Pennsylvania sees an average of 54-65 cirrhotic patients admitted to the hepatology service every month. Many of these admissions are preventable and can be attributed to poor medication adherence and late detection of clinical deterioration. By introducing a telehealth intervention following hospital discharge, investigators seek to decrease the number of readmissions for these patients by encouraging and assisting with improved adherence and by regularly tracking the progression of symptoms.
This interventional study will serve a dual purpose of helping both the patient and their provider. Patients will obtain an extra line of communication to their providers that eases their ability to access resources and alert their providers to new symptoms. Similarly, by instituting a triaged system of communication with the patient, their health team is able to offer more individualized treatment while also providing more immediate attention at the first signs of clinical deterioration. This study will determine rates of 30 and 90-day readmissions in both cohorts as a way to examine the impact of a simple telehealth intervention compared to standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily telehealth follow-up | Experimental | Behavioral: InterventionThe intervention arm will receive a simple telehealth intervention utilizing the Way to Health Platform engineered at the University of Pennsylvania. This platform will be used to send daily SMS messages to patients for 90 days following discharge and alert the research team to changes in patients' status. In addition, the patients in the intervention arm will receive a weekly phone call administered by members of the research team to assess their overall progress and well-being. |
| Standard of care follow-up | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of cirrhosis of the liver
- Admitted to the Hospital of the University of Pennsylvania
- Ability to read and provide informed consent in English
- Ability to read and provide informed consent or surrogate present who can provide consent
- Possess a cell phone and willing to receive text messages.
Key exclusion criteria (9 listed)
- Inability to provide informed consent in English
- Inability to provide informed consent or lack of surrogate who can provide consent
- Non-Cirrhotic
- Has received a liver transplant
- Discharged to hospice or has a disease process other than cirrhosis (i.e. severe heart disease or cancer) accounting for a high chance of mortality in the next 6 months.
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 |
|---|---|---|
| InterventionTelehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms. | Behavioural | Daily telehealth follow-up |
Primary outcome
A change in readmission rates of cirrhotic patients
Time frame: 90 Days
Number of hospital readmissions during the 90 day intervention compared to control arm
1 secondary outcome
A difference in patient or caregiver satisfaction post-discharge.
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
Vandana Khungar, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cirrhosis, Liver and Liver Diseases, run by University of Pennsylvania 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 6 inclusion and 9 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 5 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A change in readmission rates of cirrhotic patients (time frame: 90 Days). 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 5 Mar 2024.