Clinical trial NCT03627338: Medication Adherence in Patients With Liver Cirrhosis
Official title: Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Adherence
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In addition to inclusion criteria: Treatment with Norfloxacin, Non-selective beta blockers and/or diuretics

Brief summary: With this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis

Detailed description: The main objective of the study is to investigate drug adherence in cirrhotic patients and to gain a better understanding of the causes of deficient adherence including evaluation for medication beliefs, satisfaction, depression, anxiety and health-related quality of life. A number of long-term medications have been approved for this group of patients in various indications and / or recommended by guidelines. However, adherence has not been adequately investigated yet. The investigators aim to focus on the following groups of ingredients / classes:

* Primary and secondary antibiotic prophylaxis (e.g. Norfloxacin)
* Non-selective beta-blockers (e.g. Carvedilol and Propranolol)
* diuretics (Spirolactones \[e.g. Spironolacton\], loop diuretics) Methodically, this is will be investigated in particular by taking into account the patients history, standardized questionnaires and validated interviews.

Eligibility criteria: Inclusion Criteria:

* Treatment at Dept. of Gastroenterology, Hepatology and Endocrinology at Med. School of Hannover
* Liver cirrhosis
* Written consent for the use of personal data and health data for the purpose of this study

Exclusion Criteria:

* lack of written consent
* No consent ability
* Lack of literacy
* Inadequate knowledge of German language

Primary outcomes:
measure: Medication adherence with BAASIS
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Medication adherence with MARS
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
Secondary outcomes:
measure: Medication satisfaction
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Medication belief
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Depression
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Anxiety
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: health-related Quality of Life
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Medication knowledge
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
measure: Sociodemographic data
timeFrame: One-point first visit, cross-section-designed study during the 24 month study period
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School of Hannover
Study officials:
affiliation: Medical School of Hannover
name: Benjamin Maasoumy, Associate Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: