Telehealth Intervention in Cirrhotics

NCT03969186 | Completed

• 2 other identifiers: 828183chbgaidc
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cirrhosis, Liver; Liver Diseases

Keywords

Telehealth; Cirrhosis; Ascites; Hepatic encephalopathy; Readmissions; Preventable readmissions; Liver diseases; Variceal bleeding

Outcome Measures

Primary Outcomes (1)

• A change in readmission rates of cirrhotic patients

  Number of hospital readmissions during the 90 day intervention compared to control arm

  90 Days

Secondary Outcomes (1)

• A difference in patient or caregiver satisfaction post-discharge.

  90 Days

Study Arms (2)

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.

Behavioral: Intervention

Standard of care follow-up

NO INTERVENTION

Standard of care

Interventions

Intervention BEHAVIORAL

Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.

Daily telehealth follow-up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Actively using illicit substances or alcohol
• No access to cell phone with texting capability
• Not followed at the Hospital of the University of Pennsylvania

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

The Hospital of the University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases; Fibrosis; Ascites; Hepatic Encephalopathy

Interventions

Methods

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vandana Khungar, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 31, 2019
• Study Start: October 11, 2017
• Primary Completion: June 26, 2020
• Study Completion: August 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)