risk factors
Othermonitoring risk factors due to deterioration of the liver disease
NCT Number: NCT02957253
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Gastroenterology department, Falun, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
monitoring risk factors due to deterioration of the liver disease
information and motivation to adherence to self-care instructions and medical treatment
nutritional assessment and activities to prevent malnutrition
motivation of lifestyle changes essential for disease progress and
psychosocial care.
compensated disease once yearly, decompensated disease twice a month to every third month
Time frame: At baseline after 12 and 24 months
Patient survey using the instrument from Research and development, RAND 36-item heath survey
Time frame: At baseline after 12 and 24 months
Severity of ascites is grouped as none, mild or severe
Time frame: At baseline after 12 and 24 months
Liver cirrhosis specific calculator to measure long time survival
Time frame: At baseline after 12 and 24 months
Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
Time frame: At baseline after 12 and 24 months
Standardized interview of a table of contents using the instrument The newest vital sign (NVS)
Time frame: At baseline after 12 and 24 months
A liver cirrhosis specific calculator to assess short time survival rate
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.
Time frame: At baseline after 12 and 24 months
Patient survey using the instrument Quality of care from the the patient's perspective (QPP)
Time frame: through study completion, 24 months
Medical Review of inpatient and outpatient care
Uppsala University
Other
Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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