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Clinical Trials/NCT03162081
NCT03162081
Active, not recruiting
Not Applicable

Medication Misuse and Dependence in Elderly Patients

University Hospital, Akershus0 sites500 target enrollmentMay 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
University Hospital, Akershus
Enrollment
500
Primary Endpoint
Dependence y/n
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly.

The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly.

In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.

Detailed Description

Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function. The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population. Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.

Registry
clinicaltrials.gov
Start Date
May 3, 2017
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Akershus
Responsible Party
Principal Investigator
Principal Investigator

Christofer Lundqvist

Principal investigator

University Hospital, Akershus

Eligibility Criteria

Inclusion Criteria

  • Admitted to geriatric or Neurology dept of hospital during inclusion time

Exclusion Criteria

  • MMSE \< 21,
  • diagnosis of pre-existing severe depression or psychotic disease,
  • pre-existing dementia diagnosis,
  • new pain requiring start-up of central pain killers not previously used,
  • Palliative treatment.
  • Insufficient Norwegian language
  • Serious visual disturbance and hearing impairment
  • Strongly reduced general health precluding partcipation in interview and questionnaires

Outcomes

Primary Outcomes

Dependence y/n

Time Frame: Within 2 weeks of admission

DSM-IV defined substance dependence assessed by MINI interview

Medication misuse y/n

Time Frame: Past year prior to in-hospital stay (data collected within 2 weeks of admission)

Use of any of: opiates/benzodiazepine/Z-hypnotics \>5 days per week for \>3 months

Secondary Outcomes

  • TUG(Within 2 weeks of admission)
  • COGNISTAT(Within 2 weeks of admission)
  • No of days of use of defined addictive medications/month(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly at discharge(Within 2 weeks (index stay may in some cases be somewhat longer))
  • MCI - Mild cognitive impairment(Within 2 weeks of admission)
  • BIS-11(Within 2 weeks of admission)
  • BIS/BAS score(Within 2 weeks of admission)
  • MMSE(Within 2 weeks of admission)
  • EQ-5D(Within 2 weeks of admission)
  • SLB(Within 2 weeks of admission)
  • Neuropsychological profiles(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly at admission(Within 2 weeks of admission)
  • Substance use disorder(Within 2 weeks)
  • Use of addictive medication y/n(Within 2 weeks of admission)
  • No. of possible side effects(Within 2 weeks of admission)
  • No. of possible serious interactions(Within 2 weeks of admission)
  • No.of inappropriate medications for elderly during in-hospital stay(Within 2 weeks of admission)

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