Trial document




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  DRKS00011134

Trial Description

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Title

Increasing medication adherence to improve patient´s safety in cardiological rehabilitation

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Trial Acronym

PaSiMed

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Even though the mortality of cardiovascular diseases has dropped in the last centuries in Germany, it`s still the most common cause of death for adults. In order to ensure the effectiveness of treating cardiovascular diseases it is key that the patients take their prescribed medicines permanently, regularly and correctly. However, in national and international literature, a medication adherence of around 50 percent is reported for many long-term therapies (e.g. hypertension, diabetes mellitus). The consequences of low drug adherence are more frequent hospital stays and a higher mortality rate further on it means higher direct and indirect costs for the german health system. The aim of this project is to develop recommendations to increase the medication adherence of cardiological facilities for medical rehabilitation.

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Brief Summary in Scientific Language

As a result of demographic changes and a longer working life it is expected that there will be a rise of chronic illnesses in the cardiological rehabilitation. A low medication adherence is nationally and international a big problem for treating chronically ill people on long term medication. Through this study it is determined what the actual medication adherence of patients in the cardiological rehabilitation is and potential barriers and benefit factors to increase medication adherence are identified.
Influence possibilities of hospitalized rehabilitation of medication adherence of chronically ill patients are examined. The manual aspect in relation to everyday life of practical recommendations is an instrument of ensuring quality and supports the patient orientation required by the cost-carriers in medical rehabilitation.

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Organizational Data

  •   DRKS00011134
  •   2016/12/15
  •   [---]*
  •   yes
  •   Approved
  •   544/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E10-E14 -  Diabetes mellitus
  •   I10-I15 -  Hypertensive diseases
  •   medication adherence
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Interventions/Observational Groups

  •   The research project is divided into two phases. After a comprehensive literature research, existing documents on medication adherence of different guidelines, institutions as well as initiatives from the german-speaking countries are brought together and checked for their transferability to the context of the rehabilitation. Subsequently, there are examines three different inpatient institutions focus groups with rehabilitants and doctors / practitioner (per N total = 24). In addition to information on medication, there are promotion factors and barriers on the three levels "organization", "employees" and "rehabilitants". To address possible interface problems between the care providers, typical changes in medication during rehabilitation, and conducive as well as obstructive conditions on structural and organizational level, employees are asked for their experiences and assessments, as well as asked for practical recommendations for the recommendations for action to be drawn up. The results form are the basis for the subsequent data collection and are included in the preparation of the recommendations for action. In order to determine the actual state, the constructs of interest are collected on the rehabilitation site at two measurement times (t0 = rehabilitation start, t1 = rehabilitation end) using standardized and validated instruments, and supplemented if necessary by specifically designed items. After the data collection, the development and manualization of the near-daily recommendations for increasing drug adherence is carried out.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary target is medication adherence, which is determined by means of standardized and modified questionnaires (self-constructed items in close relation to MMAS-8 [Moriscy Medication Adherence Scale]; MARS-D [Medication Adherence Report Scale;
Version]) at a measurement time (cross-sectional design). In addition to the operationalization of medication adherence, the correlations of the target criteria as well as the self-made and modified questionnaires are examined psychometrically.

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Secondary Outcome

Secondary target variables are patient satisfaction with the information obtained on medication (SIMS-D (Satisfaction with Information about Medicines
Scale, German version) as well as patient participation (PEF-FB-9, revised 9-item version).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2017/01/01
  •   886
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

presence of cardiovascular diseases; minimum age: 18 years; good physical, mental and psychological general condition; written declaration of consent

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Exclusion Criteria

insufficient knowledge of german; acute psychiatric or neurological diseases

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Addresses

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    • Medizinische Fakultät, Medizinische Psychologie und Medizinische Soziologie
    • Hebelstr. 29
    • 79104  Freiburg
    • Germany
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    • Pädagogische Hochschule, Institut für Psychologie
    • Prof. Dr.  Markus  Wirtz 
    • Kunzenweg 21
    • 79117  Freiburg
    • Germany
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    • Medizinische Fakultät, Medizinische Psychologie und Medizinische Soziologie
    • Ms.  PD Dr.  Mirjam  Körner 
    • Hebelstr. 29
    • 79104  Freiburg
    • Germany
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    • Medizinische Fakultät, Medizinische Psychologie und Medizinische Soziologie
    • Ms.  Katharina  Quaschning 
    • Hebelstrasse 29
    • 79104  Freiburg
    • Germany
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    • Medizinische Fakultät, Medizinische Psychologie und Medizinische Soziologie
    • Ms.  Katharina  Quaschning 
    • Hebelstrasse 29
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Fakultät, Medizinische Psychologie und Medizinische Soziologie
    • Hebelstrasse 29
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.