NCT02534805

Brief Summary

To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2025

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 5, 2015

Results QC Date

May 20, 2025

Last Update Submit

August 27, 2025

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Avoidable Readmission

    Avoidable Readmissions within 30 days.

    30 days

Study Arms (1)

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhotic subjects who are hospitalized for non-elective reasons

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jasmohan Bajaj
Organization
Virginia Commonwealth University
jasmohan.bajaj@vcuhealth.org
(804) 828-4060

Study Officials

  • Jasmohan S Bajaj, MD

    VCU Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 28, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 9, 2025

Results First Posted

July 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)