Trial document





This trial has been registered retrospectively.
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  DRKS00015850

Trial Description

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Title

Assessment of drug adherence and knowledge about the disease of patients with type 2 diabetes during inpatient admission to a diabetes clinic within the Rhine-Main region

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Type 2 diabetes (T2D) is a chronic metabolic disease that currently affects about 7.5 million adults at the age of 20 to 79 years in Germany.
In order to reduce the risks of associated diseases and adverse events during diabetes treatment, a long-term and correct use of medication and extensive knowledge of the disease are necessary.
Although it is well known that a well-adjusted blood sugar level reduces the risk of secondary disease, the therapeutic target will often not be achieved. As a result, patients with abnormal blood sugar levels, hypoglycaemia or the effects of secondary diseases are hospitalized.

The aim of the study is to identify risk factors through a structured patient interview which influence the behaviour of patients taking diabetes medication and which might be the cause of their current hospital admission. In a further study, the involvement of a pharmacist during the in-patient hospital stay will be used to develop various solution strategies in order to reduce the identified risk factors.

The participants in the study are people with diabetes over the age of 18 who already suffer of type 2 diabetes, who are taking at least three medications, who have a blood sugar level outside the target range when hospitalized, and who are able to take part in a survey about their diabetes disease and medication by a pharmacist.

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Brief Summary in Scientific Language

The planned cross-sectional study is a pilot study aimed to gain knowledge of the status of adherence of type 2 diabetes patients and their knowledge of their disease.
Therefore, a questionnaire has been developed that considers the different aspects of drug intake, patient health and current diabetes treatment. Afterwards, the recorded drug adherence and patient knowledge will be correlated to both HbA1c and fasting blood glucose levels by which the patient was admitted to hospital.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015850
  •   2019/04/24
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  •   yes
  •   Approved
  •   FF/124/2018, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   Patients with pre-existing type 2 diabetes and derailed blood glucose levels when hospitalized are asked once during their inpatient stay about their drug adherence and their knowledge of the diabetes disease on the basis of a structured questionnaire.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
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Primary Outcome

Drug adherence and patient knowledge about the diabetes disease
Evaluation based on a structured questionnaire. The questionnaire on drug adherence is based on the adherence barriers questionnaire. The questionnaire on patient knowledge is based on the Michigan Diabetes knowledge test. The patient will be interviewed during the inpatient stay.

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Secondary Outcome

Blood sugar levels: HbA1c value and fasting blood sugar at inpatient admission

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/03/11
  •   60
  •   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

Age: >= 18 years,
prescription of at least three medicaments, including at least one oral antidiabetic or Insulin,
HbA1c level at admission >= 6.5% or admission caused by hypoglycaemia,
ability to consent,
ability to understand spoken and written German

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Exclusion Criteria

New onset type 2 diabetes,
Type 1 Diabetes,
pregnancy,
homecare patients,
transfer of the patient to another ward,
In case of diagnosis of severe comorbidities, which would significantly reduce life expectancy or require extensive systemic treatment

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Addresses

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    • Chefarzt Abteilung Endokrinologie und Diabetologie Krankenhaus Sachsenhausen
    • Mr.  Ralf  Jung 
    • Schulstraße 31
    • 60594  Frankfurt am Main
    • Germany
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    • Institut für Pharmakologie, Toxikologie und Klinische PharmazieTechnische Universität Braunschweig
    • Mr.  Prof. Dr.  Stephan  Scherneck 
    • Mendelssohnstr. 1
    • 38106  Braunschweig
    • Germany
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    • Schwanen Apotheke Offenbach
    • Ms.  Michaela  Pohl 
    • Marktplatz 8
    • 63065  Offenbach
    • Germany
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Sources of Monetary or Material Support

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    • Schwanen Apotheke Offenbach
    • Marktplatz 8
    • 63065  Offenbach am Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/31
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Trial Publications, Results and other Documents

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