Medication Adherence in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose

Conditions
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Medication Adherence

Intervention / Treatment
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* Diagnostic Test: questionaire, interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Norfloxacin<br>evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life | Diagnostic Test: questionaire, interview<br>* questionaire, interview<br>|
| Non-selective beta blockers<br>evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life | Diagnostic Test: questionaire, interview<br>* questionaire, interview<br>|
| diuretics<br>evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life | Diagnostic Test: questionaire, interview<br>* questionaire, interview<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence with BAASIS | Medication adherence will be investigated by using the BAASIS interview ((Basel Assessment of Adherence with Immunosuppressive Medication Scale)) The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. For the BAASIS: Any YES on any of the questions 1a, 1B, 2 or 3 indicates an issue with implementation.YES on item 4 indicates non-persistence of medication use. For the BAASIS the Overall can be quantified with both ways: as a dichtomus variable or as a continuous variable. The dichotomous variable of the BAASIS will use the scores on the questions assessing implementation and persistence (Questions 1a, 1b, 2, 3 and 4). The continuous variable will use a Visual Analogue Scale (VAS) assessing overall medication adherence over the last 4 weeks with higher scores represent higher perceived overall adherence. | One-point first visit, cross-section-designed study during the 24 month study period | 
| Medication adherence with MARS | Medication adherence will be investigated by using the MARS (Medication Adherence Report Scale ) questionnaire (self-report). The investigators use a validated German version of this instruments. Adherence is classified by means of a reliable rating system. This 5-items scale asks respondents to rate the frequency with which they engage in each of 5 aspects of non-adherent behaviour Eg deciding to miss a dose, forgetting to take a dose), rated on a five point scale (where 5=never, 4 = rarely, 3 = sometimes, 2 = often and 1= very often). Scores for each of the 5 items were summed to give a scale score ranging from 5 to 25, where higher scores indicate higher levels of reported adherence. Adherence can be expressed as a continuous scale, or by separating into 'high' and 'low' adherence groups on the basis of scale scores. | One-point first visit, cross-section-designed study during the 24 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication satisfaction | Medication satisfactions is evaluated by using a self-report validated 19-item questionnaire ; the SIMS-D (Satisfaction with Information about Medicines Scale). Mediaction satisfaction is classified by means of a reliable rating system. | One-point first visit, cross-section-designed study during the 24 month study period | 
| Medication belief | The investigators will use the Beliefs about Medicines Questionnaire (BMQ) as reliable survey tool for recording drug-related beliefs and perceptions of their benefits and / or harms. For this projects the investigators will use most recent German version authored by Nestoriuc et al. The BMQ is divided into a general and a drug-specific section. Medication belief is classified by means of a reliable rating system. | One-point first visit, cross-section-designed study during the 24 month study period | 
| Depression | Depression will be evaluated by another self-reported instrument, the Patient Health Questionnaire (PHQ 9), which is a screening tool for depression disorders with a sufficient reliability. Depression is classified by means of a reliable rating system. | One-point first visit, cross-section-designed study during the 24 month study period | 
| Anxiety | The investigators will use GAD 7 (Generalized Anxiety Disorder Screeners), another questionnaire, to screen for general anxiety disorders. This refers to the last 2 weeks and covers the most important clinical criteria according to DSM-IV. Anxiety is classified by means of a reliable rating system. | One-point first visit, cross-section-designed study during the 24 month study period | 
| health-related Quality of Life | In addition, the investigators will use the CLDQ Chronic Liver Disease Questionnaire to examine the health-related quality of life in patients with hepatopathy regardless of severity or aetiology with high reliability. HRQoL is classified by means of a reliable rating system. The scale values of the subject are obtained by assigning 1 (always), 2 (mostly), 3 (common), 4 (repeated), 5 (sometimes), 6 (rare) and 7 (never)points. The values of the subscales of the original version are obtained by adding the items of the respective scale on the CLDQ-D evaluation sheet. The range of possible values per scale is between 1 and 7. Normative values of a representative population sample are not available. For comparison, the results of clinical trials can be used. Low values mean a reduced, high values a good health-related quality of life | One-point first visit, cross-section-designed study during the 24 month study period | 
| Medication knowledge | At last, the investigators will evaluate the participant knowledge about their medication by using a self-constructed questionnaire. For this purpose we constructed an own Rating System. | One-point first visit, cross-section-designed study during the 24 month study period | 
| Sociodemographic data | Sociodemographic data (e.g. age, education, income) will be collected with another self-constructed questionnaire in addition to already collected data of patients history from the disease record | One-point first visit, cross-section-designed study during the 24 month study period |