Transitional Care Interventions for Patients With Cirrhosis Post-TIPS

Transitional Care Interventions Post-TIPS

The investigators conducted a randomized controlled trial to describe if multidisciplinary and patient-centered transitional care interventions for patients with cirrhosis post-TIPS can improve compliance behavior and reduce complications post-TIPS after discharge.

Study Overview

• Status: Unknown
• Conditions: Fibrosis
• Intervention / Treatment: Behavioral: the prevention of complications post-TIPS

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of diagnosis of cirrhosis;
• Child-Pugh Score <10;
• Informed Consent.

Exclusion Criteria:

• Age <18 years;
• Right ventricular failure;
• Severe systemic infection;
• Hepatocellular carcinoma (HCC);
• Terminal disease; and
• Failure to provide written consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The conventional care was performed for the patients of control group
Experimental: Intervention group; the prevention of complications post-TIPS	Behavioral: the prevention of complications post-TIPS; Continuous nursing through telephone follow-up, family visits, and WeChat guided patients to prevent gastrointestinal bleeding, infection and constipation ,intake quality low-protein diet, recognize minimal encephalopathy, monitor blood ammonia, return visit regularly, deal with adverse drug reactions of anticoagulant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The compliance behavior associated with complications post-TIPS	It was surveyed using a self-designed questionnaire based on evidence. The questionnaire includes 6 items that address taking medicine on time, quality low-protein diet intake, going to sleep at a regular time, moderate exercise, emotion regulation, regular follow-up. Item responses are on a 4-point scale (0 = never to 3 = always). Data were collected by face-to-face interviews with trained transition nurses. Change is being assessed	1 and 3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)	Change is being assessed	1 and 3 months after discharge
Child-Pugh scores	Change is being assessed	Baseline, 1 and 3 months after discharge
Blood ammonia levels	Change is being assessed	Baseline, 1 and 3 months after discharge

Collaborators and Investigators

• Sponsor: Shihezi University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Estimate): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: TCI-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: According to the actual situation to decide whether to share data