Transitional Care Interventions for Patients With Cirrhosis Post-TIPS

Not Applicable

• Conditions: Fibrosis
• Interventions: Behavioral: the prevention of complications post-TIPS

• Registration Number: NCT02877953
• Lead Sponsor: Shihezi University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	the prevention of complications post-TIPS	the prevention of complications post-TIPS

Primary Outcome Measures

Name	Time	Method
The compliance behavior associated with complications post-TIPS	1 and 3 months after discharge	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

Secondary Outcome Measures

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