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Medication Adherence in Patients With Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627338
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

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

Condition or disease Intervention/treatment
Medication Adherence 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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




Primary Outcome Measures :
  1. Medication adherence with BAASIS [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  2. Medication adherence with MARS [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]

    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.



Secondary Outcome Measures :
  1. Medication satisfaction [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  2. Medication belief [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  3. Depression [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  4. Anxiety [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  5. health-related Quality of Life [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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

  6. Medication knowledge [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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.

  7. Sociodemographic data [ Time Frame: One-point first visit, cross-section-designed study during the 24 month study period ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627338


Locations
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Germany
Medical School of Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Benjamin Maasoumy, Associate Professor, MD Medical School of Hannover
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03627338    
Other Study ID Numbers: HannoverGAS-Adhaerenzprojekt
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No