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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

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date January 23, 2019
Actual Study Start Date  ICMJE November 17, 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • 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
  • 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)
  • Health care consumption [ Time Frame: through study completion, 24 months ]
    Medical Review of inpatient and outpatient care
Change History Complete list of historical versions of study NCT02957253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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
  • Child-Pugh scale [ Time Frame: At baseline after 12 and 24 months ]
    Liver cirrhosis specific calculator to measure long time survival
  • Presence of Hepatic encephalopathy [ Time Frame: At baseline after 12 and 24 months ]
    Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
  • 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)
  • 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
  • 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.
  • 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)
  • Health care consumption [ Time Frame: through study completion, 24 months ]
    Medical Review of inpatient and outpatient care
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2016)
  • 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
  • Child-Pugh scale [ Time Frame: At baseline after 12 and 24 months ]
    Liver cirrhosis specific calculator to measure long time survival
  • Presence of Hepatic encephalopathy [ Time Frame: At baseline after 12 and 24 months ]
    Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
  • Health literacy [ Time Frame: At screening ]
    Standardized interview of a table of contents using the instrument The newest vital sign (NVS)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic
Official Title  ICMJE Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Intervention (CI)
    Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
    Interventions:
    • Other: risk factors
    • Other: lifestyle
    • Other: Nurse-led clinic
  • 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
    Interventions:
    • Other: risk factors
    • Other: self-care
    • Other: nutrition
    • Other: lifestyle
    • Other: psychosocial needs
    • Other: Nurse-led clinic
  • No Intervention: Control (DC)
    Decompensated Control (DC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2016)
570
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Hjorth, PhD Student +46730280705 maria.hjorth@ltdalarna.se
Contact: Fredrik Rorsman, Ass prof +46704250993 fredrik.rorsman@medsci.uu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957253
Other Study ID Numbers  ICMJE 2016/146
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Maria Hjorth, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden
  • Center for Clinical Research Dalarna, Sweden
Investigators  ICMJE
Study Chair: Lars Rönnblom, Professor Dept of Medical Sciencies, Uppsala University, Uppsala, Sweden
PRS Account Uppsala University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP