Medikamentenadhärenz Bei Patientinnen Und Patienten Mit Leberzirrhose
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Medication adherence with MARS
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •lack of written consent
- •No consent ability
- •Lack of literacy
- •Inadequate knowledge of German language
结局指标
主要结局
Medication adherence with MARS
时间窗: 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.
Medication adherence with BAASIS
时间窗: 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.
次要结局
- Medication satisfaction(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)
- 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)
- health-related Quality of Life(One-point first visit, cross-section-designed study during the 24 month study period)
- Medication knowledge(One-point first visit, cross-section-designed study during the 24 month study period)
- Sociodemographic data(One-point first visit, cross-section-designed study during the 24 month study period)