Medication Adherence in Patients With Liver Cirrhosis

Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose

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

Study Overview

• Status: Unknown
• Conditions: Medication Adherence
• Intervention / Treatment: Diagnostic test: questionaire, interview

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medical School of Hannover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In addition to inclusion criteria: Treatment with Norfloxacin, Non-selective beta blockers and/or diuretics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Norfloxacin; evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life	Diagnostic test: questionaire, interview; questionaire, interview
Non-selective beta blockers; evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life	Diagnostic test: questionaire, interview; questionaire, interview
diuretics; evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life	Diagnostic test: questionaire, interview; questionaire, interview

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Benjamin Maasoumy, Associate Professor, MD, Medical School of Hannover

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HannoverGAS-Adhaerenzprojekt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No