An interventional study of Health-IT +/- Scheduled Follow Up in Cirrhosis, sponsored by Virginia Commonwealth University. Completed at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention
SPECIFIC AIM 1: To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care.
Cirrhosis affects more than 6 million US patients and is a major burden on patients, caregivers and the healthcare system. Patients with cirrhosis are prone to clinical and psycho-social issues that may predict hospitalization, re-hospitalizations and death. Important patient-reported outcomes (PRO) such as impaired daily functioning, sleep, cognition and pain are widely prevalent in patients with cirrhosis. These changes can independently impact hospitalizations, re-hospitalizations and death in cirrhotic patients. The investigators have studied the impact of these PRO using traditional and computerized scales such as PROMIS (Patient-reported outcomes measurement information system). With the increasing spread of health-related electronic devices, the relevance of health IT in the management of chronic diseases such as cirrhosis is paramount. The team has already developed and used several health IT advances to educate patients and their caregivers in inpatient and outpatient settings. These tools are Patient Buddy to define patients regarding factor preventing readmission, and EncephalApp Stroop to detect cognitive dysfunction in cirrhosis. As part of a funded AHRQ R21, PatientBuddy, which has undergone multiple refinements in response to feedback from patients, caregivers and administering staff, is being used by the study team to prevent readmissions to Virginia Commonwealth University Medical Center (VCU). However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is an important step towards improvement in cirrhosis-related outcomes. In addition, PROs that are elicited and monitored when the patients are outside the hospital will advance the field by making them integral parts of clinical management.
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This study's enrollment of 232 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.
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Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Patient Inclusion Criteria:
Caregiver Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Exclusion Criteria
Standard of care counseling and discharge instructions per local hospital policy. Standard of care follow up phone calls and visits at baseline and at 30 days. Follow-up will be for 30 days
Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline, scheduled at 15 days and at 30 days. In addition, scheduled phone calls will be performed at days 7 and 21.Follow-up will be for 30 days
Other: Health-IT +/- Scheduled Follow Up
* Training patient and caregiver on Patient Buddy and EncephalApp * Counseling regarding readmission * Daily contact through app * Standard of care counseling regarding readmission and discharge instructions * Follow up phone calls at Week 1 and Week 3 * In-person follow up visits at Week 2 and Week 4
Avoidable Readmissions
Avoidable readmissions within 30 days
Time frame: 30 days
| Milestone | Control Group/Not Dyad | Health IT +/- Scheduled Follow Up/ no Dyads |
|---|---|---|
| Started | 116 | 116 |
| Completed | 116 | 116 |
| Not completed | 0 | 0 |
Avoidable readmissions within 30 days
| Number of avoidable readmissions | Control Group/ No Dyads | Health IT +/- Scheduled Follow Up/ no Dyads |
|---|---|---|
| Avoidable Readmissions | 12 | 23 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group/ no Dyads | 0/116 (0%) | 0/116 (0%) | 0/116 (0%) |
| Health IT +/- Scheduled Follow Up/ no Dyads | 0/116 (0%) | 0/116 (0%) | 0/116 (0%) |
| Age, Continuous(years) | Control Group/ no Dyads | Health IT +/- Scheduled Follow Up/ no Dyads | Total |
|---|---|---|---|
| Mean | 58.42 ± 8.89 | 59.1 ± 12.38 | 58.8 ± 10.6 |
| Sex: Female, Male(Participants) | Control Group/ no Dyads | Health IT +/- Scheduled Follow Up/ no Dyads | Total |
|---|---|---|---|
| Female | 40 | 58 | 98 |
| Male | 76 | 58 | 134 |
| Ethnicity (NIH/OMB)(Participants) | Control Group/ no Dyads | Health IT +/- Scheduled Follow Up/ no Dyads | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 |
| Not Hispanic or Latino | 110 | 110 | 220 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control Group/ no Dyads | Health IT +/- Scheduled Follow Up/ no Dyads | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 36 | 53 | 89 |
| White | 80 | 63 | 143 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Group/ no Dyads | Health IT +/- Scheduled Follow Up/ no Dyads | Total |
|---|---|---|---|
| United States | 116 | 116 | 232 |
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Virginia Commonwealth University