CirrhosisNCT02534805
Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
An observational study of Cirrhosis, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jan 2017
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic subjects who are hospitalized for non-elective reasons
Who may be able to join
- Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
- Adult caregiver and the patient living in the same house
- Both (caregiver and patient) should be able to complete the Patient Buddy training and evaluation
- Discharged home from the hospital
- Patients who have VCU as a primary hospital base
Who cannot join
- Elective hospitalization
- Lack of an adult caregiver
- Active alcohol/substance abuse within 1 month of the hospitalization
- Unable to perform training or give consent
- Patients discharged to hospice, nursing home or extended care facilities
- Patients on Hemodialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.
Read the detailed description
Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU.
Specific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies
- Conditions
- Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient Buddy | Subjects and caregivers will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidable Readmission
Avoidable Readmissions within 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completionJan 2017
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 CirrhosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, VCU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534805
- Sponsor's protocol ID
- HM20003950
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2015
- Last updated
- 9 Sep 2025
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
- ClinicalTrials.gov ID
- NCT02534805
- Acronym / sponsor ID
- HM20003950
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.
Detailed description
Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU.
Specific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Buddy | – | –Subjects and caregivers will be given iphones loaded with the App that will be used to enter medications, issues and orientation questions. They will be seen at day 15 and day 30 and will receive a phone call day 7 and day 21 inquiring about issues that would need medical attention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic subjects who are hospitalized for non-elective reasons
Key inclusion criteria (5 listed)
- Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
- Adult caregiver and the patient living in the same house
- Both (caregiver and patient) should be able to complete the Patient Buddy training and evaluation
- Discharged home from the hospital
- Patients who have VCU as a primary hospital base
Key exclusion criteria (6 listed)
- Elective hospitalization
- Lack of an adult caregiver
- Active alcohol/substance abuse within 1 month of the hospitalization
- Unable to perform training or give consent
- Patients discharged to hospice, nursing home or extended care facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Avoidable Readmission
Time frame: 30 days
Avoidable Readmissions within 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jasmohan S Bajaj, MD principal investigator
VCU Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Virginia Commonwealth University 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 5 inclusion and 6 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 9 Sep 2025. 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 Jul 2025). 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?
Avoidable Readmission (time frame: 30 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 9 Sep 2025.