Liver CirrhosisNurseAIDNCT04158986
Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis
A study testing Nurse-driven post-discharge intervention in people with Liver Cirrhosis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Nurse-driven post-discharge intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 1 Oct 2022
- 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
- Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding.
- Patients must read and understand Danish.
- Adults >18 years.
Who cannot join
- When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
- Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc.
- Patients diagnosed with an active and invasive malignant disease.
- Residency outside the catchment area of Amager Hvidovre Hospital.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Amager Hvidovre
Copenhagen, Hvidovre, 2650
About this study
Official title: Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis
In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.
Read the detailed description
Since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. Grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. These patients have a higher 90-day mortality rate than those who avoid readmission. Re-admissions have great personal-, societal- and economic consequences.
In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated.
The intervention, based on concepts from Family Nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. After 12 weeks the participants will be followed-up by telephone.
- Conditions
- Liver Cirrhosis
- Being tested
- Nurse-driven post-discharge intervention
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-driven post-discharge interventionBehavioural
Home visits based on the concepts of Family Nursing:
The participants will receive three home visits by a nurse who is trained in the Family Nursing principles during the first 12 weeks after discharge.
The home visits will comprise of:
- Filling in the Chronic Liver Disease Questionnaire.
- Therapeutic conversations including drawing and review of genogram and eco-map.
- Information about- and help to initiate contact to relevant municipal offers.
- Evidence-based information based on the patient's current problems or symptoms, base-line knowledge and receptiveness.
Follow-up telephone calls:
- After the first 12 weeks participants will be followed-up by telephone monthly during the following 12 weeks.
Pamphlet:
- All participants will receive a pamphlet with brief information regarding preventive measures and early signs of decompensation as well as relevant contact details. The pamphlet will be handed out before discharge
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory. |
| Nurse-driven post-discharge intervention | Experimental | Participates in a nurse-driven post-discharge intervention program. Receives: Behavioral: Nurse-driven post-discharge intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from discharge to first readmission.
Time from discharge to first readmission.
Measured: Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.
Number of readmissions
Number of readmissions within 2 years
Measured: Number of readmissions within 2 years.
Duration of readmissions
Duration of readmissions due to liver cirrhosis
Measured: Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Secondary outcomes (4)
Health related quality of life before and after intervention
Measured by the Chronic Liver Disease Questionnaire (CLDQ), which comprises 29 questions split into six domains. Domain scores and an overall score are presented on a 1-7 scale. Higher scores represents better HRQOL.
Measured: The change in health related quality of life before and after intervention (6 months trial time).
Self-perceived health before and after intervention
Measured by SF-12v2® Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.
Measured: The change in self-perceived health before and after intervention (6 months trial time).
Functional disability in work-, social-, and family life before and after intervention
Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.
Measured: The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
Mortality
Mortality after 6 months, 12 months and 2 years
Measured: The mortality rate after 6 months, 12 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Dec 2019
- Primary completion13 Oct 2021
- Study completion1 Oct 2022
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 Liver CirrhosisStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Barfod O'Connell, Copenhagen University Hospital, Hvidovre
- Investigators
- Malene Barfod O'Connell, RN, MScPH, Principal investigator, Amager Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158986
- Sponsor's protocol ID
- Splcirr2019
- Acronym
- NurseAID
- Status last verified
- Dec 2022
- First submitted
- 23 Oct 2019
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barfod O'Connell M, Brodsgaard A, Matthe M, Hobolth L, Wullum L, Bendtsen F, Kimer N. A randomized controlled trial of a postdischarge nursing intervention for patients with decompensated cirrhosis. Hepatol Commun. 2024 Apr 26;8(5):e0418. doi: 10.1097/HC9.0000000000000418. eCollection 2024 May 1.
PubMed 38668732
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04158986
- Acronym / sponsor ID
- NurseAID / Splcirr2019
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- 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.
In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.
Detailed description
Since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. Grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. These patients have a higher 90-day mortality rate than those who avoid readmission. Re-admissions have great personal-, societal- and economic consequences.
In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated.
The intervention, based on concepts from Family Nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. After 12 weeks the participants will be followed-up by telephone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory. |
| Nurse-driven post-discharge intervention | Experimental | Behavioral: Nurse-driven post-discharge interventionParticipates in a nurse-driven post-discharge intervention program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding.
- Patients must read and understand Danish.
- Adults >18 years.
Key exclusion criteria (4 listed)
- When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
- Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc.
- Patients diagnosed with an active and invasive malignant disease.
- Residency outside the catchment area of Amager Hvidovre Hospital.
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 |
|---|---|---|
| Nurse-driven post-discharge interventionHome visits based on the concepts of Family Nursing: The participants will receive three home visits by a nurse who is trained in the Family Nursing principles during the first 12 weeks after discharge. The home visits will comprise of: * Filling in the Chronic Liver Disease Questionnaire. * Therapeutic conversations including drawing and review of genogram and eco-map. * Information about- and help to initiate contact to relevant municipal offers. * Evidence-based information based on the patient's current problems or symptoms, base-line knowledge and receptiveness. Follow-up telephone calls: • After the first 12 weeks participants will be followed-up by telephone monthly during the following 12 weeks. Pamphlet: • All participants will receive a pamphlet with brief information regarding preventive measures and early signs of decompensation as well as relevant contact details. The pamphlet will be handed out before discharge | Behavioural | Nurse-driven post-discharge intervention |
Primary outcome
Time from discharge to first readmission.
Time frame: Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.
Time from discharge to first readmission.
Number of readmissions
Time frame: Number of readmissions within 2 years.
Number of readmissions within 2 years
Duration of readmissions
Time frame: Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Duration of readmissions due to liver cirrhosis
4 secondary outcomes
Health related quality of life before and after intervention
Time frame: The change in health related quality of life before and after intervention (6 months trial time).
Self-perceived health before and after intervention
Time frame: The change in self-perceived health before and after intervention (6 months trial time).
Functional disability in work-, social-, and family life before and after intervention
Time frame: The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
Mortality
Time frame: The mortality rate after 6 months, 12 months and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Derived from this study: PubMed 38668732Barfod O'Connell M, Brodsgaard A, Matthe M, Hobolth L, Wullum L, Bendtsen F, Kimer N. A randomized controlled trial of a postdischarge nursing intervention for patients with decompensated cirrhosis. Hepatol Commun. 2024 Apr 26;8(5):e0418. doi: 10.1097/HC9.0000000000000418. eCollection 2024 May 1.
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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.
Malene Barfod O'Connell, RN, MScPH principal investigator
Amager Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-driven post-discharge intervention in people with Liver Cirrhosis, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from discharge to first readmission. (time frame: Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.). The study lists 3 primary outcomes in all. 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 NCT04158986, 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 30 Dec 2022.