Back to resultsTransitional Care Interventions for Patients With Cirrhosis Post-TIPS
Primary Purpose
Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the prevention of complications post-TIPS
Sponsored by
About this trial
This is an interventional prevention trial for Fibrosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
The conventional care was performed for the patients of control group
the prevention of complications post-TIPS
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)
Change is being assessed
Child-Pugh scores
Change is being assessed
Blood ammonia levels
Change is being assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02877953
Brief Title
Transitional Care Interventions for Patients With Cirrhosis Post-TIPS
Official Title
Transitional Care Interventions Post-TIPS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shihezi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The conventional care was performed for the patients of control group
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
the prevention of complications post-TIPS
Intervention Type
Behavioral
Intervention Name(s)
the prevention of complications post-TIPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
The compliance behavior associated with complications post-TIPS
Description
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
Time Frame
1 and 3 months after discharge
Secondary Outcome Measure Information:
Title
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)
Description
Change is being assessed
Time Frame
1 and 3 months after discharge
Title
Child-Pugh scores
Description
Change is being assessed
Time Frame
Baseline, 1 and 3 months after discharge
Title
Blood ammonia levels
Description
Change is being assessed
Time Frame
Baseline, 1 and 3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
According to the actual situation to decide whether to share data
Learn more about this trial
Transitional Care Interventions for Patients With Cirrhosis Post-TIPS
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