Copenhagen University Hospital, Amager Hvidovre
Copenhagen, Hvidovre, 2650, Denmark
NCT Number: NCT04158986
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Hvidovre, 2650, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Follow-up telephone calls:
Pamphlet:
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.
Time frame: Number of readmissions within 2 years.
Number of readmissions within 2 years
Time frame: Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Duration of readmissions due to liver cirrhosis
Time frame: The change in health related quality of life before and after intervention (6 months trial time).
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.
Time frame: The change in self-perceived health before and after intervention (6 months trial time).
Measured by SF-12v2® Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.
Time frame: The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.
Time frame: The mortality rate after 6 months, 12 months and 2 years
Mortality after 6 months, 12 months and 2 years
Copenhagen University Hospital, Hvidovre
Other
Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis
Acronym: NurseAID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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