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Liver CirrhosisNCT02957253

Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic

A study testing risk factors, self-care and nutrition in people with Liver Cirrhosis, run by Uppsala University at 6 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compare the effects of traditional follow-up by physician with a combined follow-up alternately by physician and nurse-led clinic. The main variable is; health related quality of Life. Participants are randomized into control group or intervention group. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Liver Cirrhosis
What is being tested?
risk factors, self-care and nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
6 sitesSweden
Study dates
17 Nov 2016to 31 Dec 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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • within the last 24 months diagnosed liver cirrhosis based on clinical investigation, laboratory findings, histology, magnetic resonance imaging, computer tomography, ultrasound or elastography
  • followed at one of the six Gastroenterology departments

Who cannot join

  • Insufficient knowledge of the Swedish language
  • Persistent hepatic ecephalopathy grades 2-4
  • Comorbidity: Chronic obstructive pulmonary disease grade 3-4, Coronary heart disease New York Heart Association Functional Classification class 3-4, Dementia, Actual advanced cancer, Stroke with sequelae, Severe psychiatric disease, Renal failure requiring dialysis

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Sweden6 sites

  • Gastroenterology department

    Falun, 791 82

  • Gastroenterology outpatientclinic, Sahlgrenska hospital

    Gothenburg, 41345

  • Gastroenterology outpatient department, Skane Universityhospital

    Malmö, 20502

  • Gastroenterology department, Örebro Universityhospital

    Örebro, 701 85

  • Gastroenterology department, Danderyd hospital

    Stockholm, 182 88

  • Gastroenterology department, Uppsala academical hospital

    Uppsala, 751 85

Other trials in Sweden

About this study

Official title: Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial

This study compare the effects of traditional follow-up by physician with a combined follow-up alternately by physician and nurse-led clinic. The main variable is; health related quality of Life. Participants are randomized into control group or intervention group.

Read the detailed description

The incidence of liver cirrhosis in Sweden increase mostly due to life style factors. A large need of care is common in the end stage of the disease. Nurse-led clinics for other groups of patients, e.g. coronary heart disease, have shown high quality which has resulted in an established part of the follow-up.

This study is a randomized controlled study at six Swedish hospitals to study the effect of a changed follow-up process for liver cirrhotic patients by adding a nurse-led clinic to follow up by physician. The intervention implies a larger extend of nursing interventions at the outpatient clinic to increase the patient's quality of life, quality of care and reduce the need of inpatient care.

A few hospitals in Sweden offers a nurse-led clinic for liver cirrhotic patients, the interest in other hospitals are raising. Though there is a lack of evidence in nursing intervention within this population and it is still unknown what the effects are for the individual or on the health economy.

Conditions
Liver Cirrhosis
Being tested
risk factors, self-care, nutrition, lifestyle, psychosocial needs
Keywords
Quality of care, Health related quality of life, Nurse-led clinic, Health economics
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • risk factorsOther

    monitoring risk factors due to deterioration of the liver disease

  • self-careOther

    information and motivation to adherence to self-care instructions and medical treatment

  • nutritionOther

    nutritional assessment and activities to prevent malnutrition

  • lifestyleOther

    motivation of lifestyle changes essential for disease progress and

  • psychosocial needsOther

    psychosocial care.

  • Nurse-led clinicOther

    compensated disease once yearly, decompensated disease twice a month to every third month

Study groups in NCT02957253
Study groupRoleWhat they receive
Intervention (CI)ExperimentalCompensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
Receives: Other: risk factors; Other: lifestyle; Other: Nurse-led clinic
Control (CC)No interventionCompensated Control (CC)
Intervention (DI)ExperimentalDecompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
Receives: Other: risk factors; Other: self-care; Other: nutrition; Other: lifestyle; Other: psychosocial needs; Other: Nurse-led clinic
Control (DC)No interventionDecompensated Control (DC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Health related quality of life

    Patient survey using the instrument from Research and development, RAND 36-item heath survey

    Measured: At baseline after 12 and 24 months

Secondary outcomes (8)

  1. Clinical examination of presence of ascites

    Severity of ascites is grouped as none, mild or severe

    Measured: At baseline after 12 and 24 months

  2. Child-Pugh scale

    Liver cirrhosis specific calculator to measure long time survival

    Measured: At baseline after 12 and 24 months

  3. Presence of Hepatic encephalopathy

    Paper and pencil test the psychometric hepatic encephalopathy score (PHES)

    Measured: At baseline after 12 and 24 months

  4. Health literacy

    Standardized interview of a table of contents using the instrument The newest vital sign (NVS)

    Measured: At baseline after 12 and 24 months

  5. Model of end stage liver disease (MELD-score)

    A liver cirrhosis specific calculator to assess short time survival rate

    Measured: At baseline after 12 and 24 months

  6. Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool

    A liver cirrhosis specific instrument will be used to assess the risk of malnutrition. The risk is subdivided into low, moderate or high risk.

    Measured: At baseline after 12 and 24 months

  7. Changes in patients experienced Quality of care

    Patient survey using the instrument Quality of care from the the patient's perspective (QPP)

    Measured: At baseline after 12 and 24 months

  8. Health care consumption

    Medical Review of inpatient and outpatient care

    Measured: through study completion, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study start17 Nov 2016
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02957253
Sponsor's protocol ID
2016/146
Status last verified
Mar 2023
First submitted
18 Oct 2016
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No: The data that support the findings of this study are available from Region Dalarna upon reasonable request, provided that the data can be made available in accordance with applicable data protection and privacy regulations. Contact information: Maria Hjorth, maria.hjorth@regiondalarna.se and diariet@regiondalarna.se

Publications

  • Arguedas MR, DeLawrence TG, McGuire BM. Influence of hepatic encephalopathy on health-related quality of life in patients with cirrhosis. Dig Dis Sci. 2003 Aug;48(8):1622-6. doi: 10.1023/a:1024784327783.

    PubMed 12924658

  • Abdi F, Daryani NE, Khorvash F, Yousefi Z. Experiences of Individuals With Liver Cirrhosis: A Qualitative Study. Gastroenterol Nurs. 2015 Jul-Aug;38(4):252-7. doi: 10.1097/SGA.0000000000000122.

    PubMed 26226019

  • Arvidsson SB, Petersson A, Nilsson I, Andersson B, Arvidsson BI, Petersson IF, Fridlund B. A nurse-led rheumatology clinic's impact on empowering patients with rheumatoid arthritis: A qualitative study. Nurs Health Sci. 2006 Sep;8(3):133-9. doi: 10.1111/j.1442-2018.2006.00269.x.

    PubMed 16911172

  • Biddle ML, Adler NR, Heath M, Streat S, Wardrop M, Watson JP. Nurse-led clinic: effective and efficient delivery of assessment and review of patients with hepatitis B and C. Intern Med J. 2014 Jun;44(6):581-5. doi: 10.1111/imj.12400.

    PubMed 24612294

  • Bleibel W, Al-Osaimi AM. Hepatic encephalopathy. Saudi J Gastroenterol. 2012 Sep-Oct;18(5):301-9. doi: 10.4103/1319-3767.101123.

    PubMed 23006457

  • Borhofen SM, Gerner C, Lehmann J, Fimmers R, Gortzen J, Hey B, Geiser F, Strassburg CP, Trebicka J. The Royal Free Hospital-Nutritional Prioritizing Tool Is an Independent Predictor of Deterioration of Liver Function and Survival in Cirrhosis. Dig Dis Sci. 2016 Jun;61(6):1735-43. doi: 10.1007/s10620-015-4015-z. Epub 2016 Jan 2.

    PubMed 26725059

  • Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.

    PubMed 21389250

  • Chaney A, Werner KT & Kipple T. Primary care management of hepatic encephalopathy: A common cirrhosis complication. The journal for Nurse Practisioners. 11(3): 300-306, 2015.

  • Disler RT, Gallagher RD, Davidson PM. Factors influencing self-management in chronic obstructive pulmonary disease: an integrative review. Int J Nurs Stud. 2012 Feb;49(2):230-42. doi: 10.1016/j.ijnurstu.2011.11.005. Epub 2011 Dec 6.

    PubMed 22154095

  • Evangelista LS, Shinnick MA. What do we know about adherence and self-care? J Cardiovasc Nurs. 2008 May-Jun;23(3):250-7. doi: 10.1097/01.JCN.0000317428.98844.4d.

    PubMed 18437067

  • Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.

    PubMed 11491194

  • Hommel A, Idvall E & Andersson AC. Kvalitetsutveckling: Kvalitet och omvårdnad. I AK Edberg, A Ehrenberg, F Friberg, L Wallin, H Wijk & J Öhlén (Eds) Omvårdnad på avancerad nivå: Kärnkompetenser inom sjuksköterskans specialistområden (1st ed, pp. 147-150), 2013.

  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PubMed 8275167

  • Infante-Rivard C, Esnaola S, Villeneuve JP. Clinical and statistical validity of conventional prognostic factors in predicting short-term survival among cirrhotics. Hepatology. 1987 Jul-Aug;7(4):660-4. doi: 10.1002/hep.1840070408.

    PubMed 3610046

  • Jahren Kristoffersen N, Nortveldt F & Skaug EA. Grundläggande omvårdnad del 1. Stockholm: Liber AB, 2005.

Questions about this trial

What is this clinical trial studying?

A study testing risk factors, self-care and nutrition in people with Liver Cirrhosis, run by Uppsala University at 6 sites in Sweden.

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 2 inclusion and 3 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. 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?

Changes in Health related quality of life (time frame: At baseline after 12 and 24 months). 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 NCT02957253, which also lists 46 linked publications.

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 Mar 2023.

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