Transitional Care Interventions for Patients With Cirrhosis Post-TIPS

Fibrosis Clinical Trial

Official title:

Transitional Care Interventions Post-TIPS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02877953
• Other study ID #: TCI-2016
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 23, 2016
• Start date: January 2013

Study information

• Verified date: August 2016
• Source: Shihezi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: The Local Department of Health and Family Planning Commission of Xinjiang Shihezi
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shihezi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of adverse events (shunt dysfunction and hepatic encephalopathy)	Change is being assessed	1 and 3 months after discharge	No
Secondary	Child-Pugh scores	Change is being assessed	Baseline, 1 and 3 months after discharge	No
Secondary	Blood ammonia levels	Change is being assessed	Baseline, 1 and 3 months after discharge	No