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

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ClinicalTrials.gov Identifier: NCT02957253
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : January 23, 2019
Sponsor:
Collaborators:
Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden
Center for Clinical Research Dalarna, Sweden
Information provided by (Responsible Party):
Maria Hjorth, Uppsala University

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Other: risk factors Other: self-care Other: nutrition Other: lifestyle Other: psychosocial needs Other: Nurse-led clinic Not Applicable

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 five 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial
Actual Study Start Date : November 17, 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention (CI)
Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
Other: risk factors
monitoring risk factors due to deterioration of the liver disease

Other: lifestyle
motivation of lifestyle changes essential for disease progress and

Other: Nurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month

No Intervention: Control (CC)
Compensated Control (CC)
Experimental: Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
Other: risk factors
monitoring risk factors due to deterioration of the liver disease

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

Other: nutrition
nutritional assessment and activities to prevent malnutrition

Other: lifestyle
motivation of lifestyle changes essential for disease progress and

Other: psychosocial needs
psychosocial care.

Other: Nurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month

No Intervention: Control (DC)
Decompensated Control (DC)



Primary Outcome Measures :
  1. Changes in Health related quality of life [ Time Frame: At baseline and after 24 months ]
    Patient survey using the instrument from Research and development, RAND 36-item heath survey


Secondary Outcome Measures :
  1. Clinical examination of presence of ascites [ Time Frame: At baseline after 12 and 24 months ]
    Severity of ascites is grouped as none, mild or severe

  2. Child-Pugh scale [ Time Frame: At baseline after 12 and 24 months ]
    Liver cirrhosis specific calculator to measure long time survival

  3. Presence of Hepatic encephalopathy [ Time Frame: At baseline after 12 and 24 months ]
    Paper and pencil test the psychometric hepatic encephalopathy score (PHES)

  4. Health literacy [ Time Frame: At baseline after 12 and 24 months ]
    Standardized interview of a table of contents using the instrument The newest vital sign (NVS)

  5. Model of end stage liver disease (MELD-score) [ Time Frame: At baseline after 12 and 24 months ]
    A liver cirrhosis specific calculator to assess short time survival rate

  6. Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool [ Time Frame: At baseline after 12 and 24 months ]
    A liver cirrhosis specific instrument will be used to assess the risk of malnutrition. The risk is subdivided into low, moderate or high risk.

  7. Changes in patients experienced Quality of care [ Time Frame: At baseline and after 24 months ]
    Patient survey using the instrument Quality of care from the the patient's perspective (QPP)

  8. Health care consumption [ Time Frame: through study completion, 24 months ]
    Medical Review of inpatient and outpatient care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957253


Contacts
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Contact: Maria Hjorth, PhD Student +46730280705 maria.hjorth@ltdalarna.se
Contact: Fredrik Rorsman, Ass prof +46704250993 fredrik.rorsman@medsci.uu.se

Locations
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Sweden
Gastroenterology department Recruiting
Falun, Sweden, 791 82
Contact: Maria Hjorth    +46730280705    maria.hjorth@ltdalarna.se   
Contact: Daniel Sjöberg    +4623492568    daniel.sjoberg@ltdalarna.se   
Gastroenterology outpatientclinic, Sahlgrenska hospital Recruiting
Gothenburg, Sweden, 41345
Contact: IngaLill FriisLiby, MD       ingalill.friis-liby@vgregion.se   
Gastroenterology outpatient department, Skane Universityhospital Recruiting
Malmo, Sweden, 20502
Contact: Daniel Klintman, MD       daniel.klintman@skane.se   
Gastroenterology department, Danderyd hospital Recruiting
Stockholm, Sweden, 182 88
Contact: Jonas Alzén    +46812357264    jonas.alzen@sll.se   
Contact: matilda Eriksson    +4612358341    matilda.eriksson@sll.se   
Gastroenterology department, Uppsala academical hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Fredrik Rorsman    +46704250993    fredrik.rorsman@medsci.uu.se   
Contact: Inger Gustafsson    +46186110817    inger.gustafsson@akademiska.se   
Gastroenterology department, Örebro Universityhospital Recruiting
Örebro, Sweden, 701 85
Contact: Nils Nyhlin       nils.nyhlin@regionorebrolan.se   
Sponsors and Collaborators
Uppsala University
Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden
Center for Clinical Research Dalarna, Sweden
Investigators
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Study Chair: Lars Rönnblom, Professor Dept of Medical Sciencies, Uppsala University, Uppsala, Sweden
  Study Documents (Full-Text)

Documents provided by Maria Hjorth, Uppsala University:

Additional Information:
Publications:
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.
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.
Jahren Kristoffersen N, Nortveldt F & Skaug EA. Grundläggande omvårdnad del 1. Stockholm: Liber AB, 2005.
Kirkevold M. Omvårdnadsteorier; Analys och utvärdering (2nd Ed). Lund: Studentlitteratur, 2000.
Larsson, B, Larsson G, Larsson M & Starrin B. KUPP-boken: Vägledning till frågeformuläret KUPP, Kvalitet ur patientperspektiv. Stockholm: Grafiska Gruppen, 2001.
Prytz H & Ståhl P. Levercirros och dess kliniska manifestationer. I R Hultcrantz, A Bergquist, S Lindgren, M Simrén, P Stål & OB Suhr (Eds.). Gastroenterologi och hepatologi. Stockholm: Liber. (1st ed, pp. 451-475), 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Hjorth, Principal investigator, Uppsala University
ClinicalTrials.gov Identifier: NCT02957253     History of Changes
Other Study ID Numbers: 2016/146
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maria Hjorth, Uppsala University:
Quality of care
Health related quality of life
Nurse-led clinic
Health economics
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases