Trial document




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  DRKS00016774

Trial Description

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Title

Adherence in neurogeriatric patients

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Trial Acronym

NeuroGerAd

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URL of the Trial

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Brief Summary in Lay Language

The treatment of chronic disorders commonly includes the long-term use of pharmacotherapy and non-pharmacological therapy. However, their full benefits are often not realized because approximately up to 50% of patients either do not take medications as prescribed or do not follow recommendations. Non-adherence contributes to adverse drug events, increased length of stay and readmissions to hospitals, a lower quality of life and higher mortality. Therefore, adherence improvement was identified by the WHO in 2003 as one of its key public health goals.
With the aging of the population and the associated increase in diseases and medications, this topic is becoming increasingly important. So far, however, there is no comprehensive data on adherence in the large and growing group of neurogeriatric patients, i. geriatric patients with a leading neurological disease. Therefore, this observational study will systematically record and analyze adherence as well as general and disease-specific factors that contribute to non-adherence in neurogeriatric patients. Because adherence is a dynamic phenomena and drug changes occur frequently after discharge from the hospital, the reasons for non-adherence will also be recorded longitudinally after discharge from the hospital.

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Brief Summary in Scientific Language

Poor adherence is a major issue and is associated with increased morbidity, mortality, and immense costs for the healthcare system. Due to demographic changes, the burden of neurological diseases in Germany is increasing with a crucial exacerbation of the problem of non-adherence. However, comprehensive data on geriatric patients with neurological disorders do not exist to date. This cross-sectional observational study will provide detailed assessment and identification of disease-specific adherence-modulating factors in neurogeriatric patients. Because adherence is a dynamic phenomenon, reasons for nonadherence after discharge from the hospital are also recorded longitudinally. These data can then be used to develop tailored complex and disease-specific interventions to improve adherence.

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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

  •   DRKS00016774
  •   2019/02/19
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  •   yes
  •   Approved
  •   5290-10/17, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   Focused on main diagnosis/disorders: cerebrovascular diseases, movement disorders, epilepsy, neuromuscular disorders, peripheral neurological disorders.
  •   G20 -  Parkinson disease
  •   G21 -  Secondary parkinsonism
  •   G23 -  Other degenerative diseases of basal ganglia
  •   G63 -  Polyneuropathy in diseases classified elsewhere
  •   G70 -  Myasthenia gravis and other myoneural disorders
  •   G72 -  Other myopathies
  •   G81 -  Hemiplegia
  •   G35 -  Multiple sclerosis
  •   G37 -  Other demyelinating diseases of central nervous system
  •   G03 -  Meningitis due to other and unspecified causes
  •   G04 -  Encephalitis, myelitis and encephalomyelitis
  •   G09 -  Sequelae of inflammatory diseases of central nervous system
  •   G40 -  Epilepsy
  •   G43 -  Migraine
  •   G44 -  Other headache syndromes
  •   G45 -  Transient cerebral ischaemic attacks and related syndromes
  •   G46 -  Vascular syndromes of brain in cerebrovascular diseases
  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
  •   I69 -  Sequelae of cerebrovascular disease
  •   G47 -  Sleep disorders
  •   G62 -  Other polyneuropathies
  •   G64 -  Other disorders of peripheral nervous system
  •   G12 -  Spinal muscular atrophy and related syndromes
  •   G11 -  Hereditary ataxia
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Interventions/Observational Groups

  •   Observational study:
    Patients aged 60 years and older with underlying neurological disorders are questioned during their stay at the Department of Neurology by means of a questionnaire: Adherence (Stendal Adherence to Medication Score, SAMS), Health-related Quality of Life (SF-36), Personality (Big Five Inventory, BFI-10), Depression (Beck Depression Inventory, BDI II), Physician-Patient relationship (Health Care Climate Questionnaire, HCCQ). In addition, general demographic factors, cognitive status (Montreal Cognitive Assessment) as well as disease-specific factors and scores are collected or extracted from the routine data. The reasons for drug changes after discharge from the hospital (months 1 and 12) as well as health-related quality of life (SF-36) and adherence (SAMS) (month 12) are recorded longitudinally by a semi-structured telephone interview.
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Characteristics

  •   Non-interventional
  •   Observational 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 endpoint is non-adherence in neurogeriatric patients derived from the Stendal Adherence with Medication Score (SAMS). Also disease-specific predictors of non-adherence, taking into account personal, environmental and procedural factors will be determined.

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Secondary Outcome

Outcome follow-up surveys non-adherence, mortality and health-related quality of life in neurogeriatric patients at 12 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/15
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients over 60 years with a neurological disease

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Exclusion Criteria

severe dementia, psychosis, delirium, inability to complete questionnaires

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik für Neurologie
    • Mr.  PD Dr. med.   Tino  Prell 
    • Am Klinikum
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Neurologie
    • Mr.  PD Dr. med.  Tino  Prell 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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