Medication Adherence in Patients With Liver Cirrhosis
Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
1 other identifier
observational
400
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedMarch 12, 2020
March 1, 2020
2.6 years
July 26, 2018
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Medication satisfaction
One-point first visit, cross-section-designed study during the 24 month study period
Medication belief
One-point first visit, cross-section-designed study during the 24 month study period
Depression
One-point first visit, cross-section-designed study during the 24 month study period
Anxiety
One-point first visit, cross-section-designed study during the 24 month study period
health-related Quality of Life
One-point first visit, cross-section-designed study during the 24 month study period
- +2 more secondary outcomes
Study Arms (3)
Norfloxacin
evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life
Non-selective beta blockers
evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life
diuretics
evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life
Interventions
questionaire, interview
Eligibility Criteria
In addition to inclusion criteria: Treatment with Norfloxacin, Non-selective beta blockers and/or diuretics
You may qualify if:
- 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
You may not qualify if:
- lack of written consent
- No consent ability
- Lack of literacy
- Inadequate knowledge of German language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical School of Hannover
Hanover, 30625, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Maasoumy, Associate Professor, MD
Medical School of Hannover
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 13, 2018
Study Start
September 1, 2018
Primary Completion
March 31, 2021
Study Completion
May 31, 2021
Last Updated
March 12, 2020
Record last verified: 2020-03