Trial document




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  DRKS00010242

Trial Description

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Title

Interview study of health literacy regarding polypharmacy and medication safety of patients aged 65 years and older: challenges and potential solutions

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Trial Acronym

MediKom

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URL of the Trial

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Brief Summary in Lay Language

Persons aged 65 and older are more likely to have several diseases. As a consequence, many of these persons have to take multiple medications. In cases where a person takes five or more medications, it is also called polypharmacy. Polypharmacy can lead to problems. For example, interactions between medications can occur or the person might forget how to take all of the medication. This can lead to hospital stays and even a higher mortality. In order to avoid polypharmacy and inappropriate medications, lists with potentially inappropriate medications and software solutions for physicians were created. However, the active involvement of patients is important, as they are managing their diseases in daily life. The aim of our study is to learn more about patient’s problems regarding their management of five or more medications and how patients can be involved to avoid or decrease these problems. We particularly want to know more about the role of the patient-physician-communication.

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Brief Summary in Scientific Language

Polypharmacy is often defined as the taking of five or more medications. It can increase the number of interactions between medications, the probability of inappropriate medications and the risk of non-adherence. This can cause adverse medication-related events like hospital stays, morbidity and mortality. Due to the higher prevalence of morbidity and multi-morbidity in persons aged 65 years and older, polypharmacy is common in this age group. Moreover, there are few study results regarding medication actions in elderly people. In order to avoid polypharmacy and inappropriate medications, lists with potentially inappropriate medications and software solutions for physicians were created. However, the active involvement of patients is important, as they are managing their diseases in daily life. The aim of our study is to identify problems of patients aged 65 years and older in managing polypharmacy and medication safety and how patients can be involved to achieve a better medication safety.

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Organizational Data

  •   DRKS00010242
  •   2016/03/29
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  •   yes
  •   Approved
  •   99/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1181-1056 
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Health Condition or Problem studied

  •   Patients with 5 or more medications
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Interventions/Observational Groups

  •   We will conduct semi-structured interviews with patients aged 65 years and older who take 5 or more medications. If patients want, a relative can take part in the interview. Moreover, we interview physicians of the cooperating doctor's practice.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Identification of problems of patients aged 65 years and older in managing polypharmacy and medication safety and of possibilities how patients can be involved to achieve a better medication safety.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/05/31
  •   22
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients aged 65 years and older who take or are prescribed 5 medications or more, their relatives and physicians in the cooperating doctor's practice

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Exclusion Criteria

no willingness to participate; persons who are not capable of filling out questionnaires in German due to cognitive, physical or language limitations

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Addresses

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    • Universitätsklinikum Freiburg Institut für Medizinische Biometrie und Medizinische Informatik Sektion Versorgungsforschung und Rehabilitationsforschung
    • Engelbergerstraße 21
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Institut für Medizinische Biometrie und Medizinische Informatik Sektion Versorgungsforschung und Rehabilitationsforschung
    • Ms.  Dr.   Andrea  Schöpf 
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Institut für Medizinische Biometrie und Medizinische Informatik Sektion Versorgungsforschung und Rehabilitationsforschung
    • Ms.  Dr.  Andrea  Schöpf 
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Institut für Medizinische Biometrie und Medizinische Informatik Sektion Versorgungsforschung und Rehabilitationsforschung
    • Hugstetter Straße 49
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/08
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Trial Publications, Results and other Documents

  •   Schöpf, A.C., von Hirschhausen, M., Farin, E. & Maun, A. (in press).Elderly patients’ and GPs’ perspectives of patient–GP communication concerning polypharmacy: a qualitative interview study. Primary Health Care Research & Development. doi:10.1017/S1463423617000883
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* This entry means the parameter is not applicable or has not been set.