Transitional Care Interventions for Patients With Cirrhosis Post-TIPS
1 other identifier
interventional
76
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedAugust 24, 2016
August 1, 2016
2.7 years
August 16, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)
1 and 3 months after discharge
Child-Pugh scores
Baseline, 1 and 3 months after discharge
Blood ammonia levels
Baseline, 1 and 3 months after discharge
Study Arms (2)
Control group
NO INTERVENTIONThe conventional care was performed for the patients of control group
Intervention group
EXPERIMENTALthe prevention of complications post-TIPS
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of diagnosis of cirrhosis;
- Child-Pugh Score \<10;
- Informed Consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yang R, Xu Y, Hou W, Wang L, Xiao S, Li C, Shao H, Fei X, Wang Z. Transitional Care for Patients With Portal Hypertension: A Multicenter Study of Intervention for Post-TIPS Patients. Clin Nurs Res. 2023 May;32(4):785-796. doi: 10.1177/10547738221112746. Epub 2022 Sep 1.
PMID: 36047431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 24, 2016
Study Start
January 1, 2013
Primary Completion
September 1, 2015
Last Updated
August 24, 2016
Record last verified: 2016-08