FibrosisNCT02877953
Transitional Care Interventions for Patients With Cirrhosis Post-TIPS
A study testing the prevention of complications post-TIPS in people with Fibrosis, run by Shihezi University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis
- What is being tested?
- the prevention of complications post-TIPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of diagnosis of cirrhosis;
- Child-Pugh Score <10;
- Informed Consent.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Fibrosis
- Being tested
- the prevention of complications post-TIPS
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the prevention of complications post-TIPSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The conventional care was performed for the patients of control group |
| Intervention group | Experimental | the prevention of complications post-TIPS Receives: Behavioral: the prevention of complications post-TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 and 3 months after discharge
Secondary outcomes (3)
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)
Change is being assessed
Measured: 1 and 3 months after discharge
Child-Pugh scores
Change is being assessed
Measured: Baseline, 1 and 3 months after discharge
Blood ammonia levels
Change is being assessed
Measured: Baseline, 1 and 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shihezi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HOU Wei-wei, Shihezi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877953
- Sponsor's protocol ID
- TCI-2016
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: According to the actual situation to decide whether to share data
Publications
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.
PubMed 36047431
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Care Interventions Post-TIPS
- ClinicalTrials.gov ID
- NCT02877953
- Acronym / sponsor ID
- TCI-2016
- Conditions
- Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shihezi UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The conventional care was performed for the patients of control group |
| Intervention group | Experimental | Behavioral: the prevention of complications post-TIPSthe prevention of complications post-TIPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of diagnosis of cirrhosis;
- Child-Pugh Score <10;
- Informed Consent.
Key exclusion criteria (6 listed)
- Age <18 years;
- Right ventricular failure;
- Severe systemic infection;
- Hepatocellular carcinoma (HCC);
- Terminal disease; and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the prevention of complications post-TIPSContinuous 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. | Behavioural | Intervention group |
Primary outcome
The compliance behavior associated with complications post-TIPS
Time frame: 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
3 secondary outcomes
incidence of adverse events (shunt dysfunction and hepatic encephalopathy)
Time frame: 1 and 3 months after discharge
Child-Pugh scores
Time frame: Baseline, 1 and 3 months after discharge
Blood ammonia levels
Time frame: Baseline, 1 and 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Derived from this study: PubMed 36047431Yang 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.
- Individual participant dataSharing planned: Undecided. According to the actual situation to decide whether to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the prevention of complications post-TIPS in people with Fibrosis, run by Shihezi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The compliance behavior associated with complications post-TIPS (time frame: 1 and 3 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.