Medication Adherence in Patients With Liver Cirrhosis

NCT ID: NCT03627338

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-05-31

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.

Conditions

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Medication Adherence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Norfloxacin

evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life

questionaire, interview

Intervention Type DIAGNOSTIC_TEST

questionaire, interview

Non-selective beta blockers

evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life

questionaire, interview

Intervention Type DIAGNOSTIC_TEST

questionaire, interview

diuretics

evaluate medication adherence, patient history, medication beliefs and medication satisfaction, depression, anxiety and health-related quality of life

questionaire, interview

Intervention Type DIAGNOSTIC_TEST

questionaire, interview

Interventions

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questionaire, interview

questionaire, interview

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Maasoumy, Associate Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Medical School of Hannover

Locations

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Medical School of Hannover

Hanover, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HannoverGAS-Adhaerenzprojekt

Identifier Type: -

Identifier Source: org_study_id

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