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Active, Not Recruiting

NCT Number: NCT03162081

Medication Misuse and Dependence Among Elderly

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mild Cognitive Impairment Behavior Behavior, Addictive Chemically-Induced Disorders Cognition Disorders Cognitive Dysfunction Compulsive Behavior Drug Misuse Elderly Impulsive Behavior Mental Disorders Neurocognitive Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Substance misuse screening

Diagnostic Test

Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)

EQ-5D

Diagnostic Test

Health related Quality of life

Impulsivity screening

Diagnostic Test

Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test

Cognitive screening

Diagnostic Test

Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test

Functional tests

Diagnostic Test

Timed up and go (TUG), Single leg balancing test (SLB)

Cognistat

Diagnostic Test

Assessment of cognitive domains

Neuropsychological profiling

Diagnostic Test

Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test

Clinical interview

Other

Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale

Medication use

Other

Detailed screen of used medications, interactions, side effects in electronic patient registry

Comorbidity

Other

Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry

Primary outcomes

  1. Dependence y/n

    Time frame: Within 2 weeks of admission

    DSM-IV defined substance dependence assessed by MINI interview

  2. 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

  1. MCI - Mild cognitive impairment

    Time frame: Within 2 weeks of admission

    Defined by MMSE < 26

  2. MMSE

    Time frame: Within 2 weeks of admission

    Numerical score of cognitive function

  3. COGNISTAT

    Time frame: Within 2 weeks of admission

    Cognitive profile

  4. EQ-5D

    Time frame: Within 2 weeks of admission

    Quality of life

  5. BIS-11

    Time frame: Within 2 weeks of admission

    Impulsivity score

  6. BIS/BAS score

    Time frame: Within 2 weeks of admission

    Behavioura inhibition/activation score

  7. TUG

    Time frame: Within 2 weeks of admission

    Functional test score (time in secs)

  8. SLB

    Time frame: Within 2 weeks of admission

    Functional test score (time in secs)

  9. Neuropsychological profiles

    Time frame: Within 2 weeks of admission

    Tests as listed

  10. Use of addictive medication y/n

    Time frame: Within 2 weeks of admission

    Prescription use of any of the following: opiates, benzodiazepines, Z-hypnotics

  11. No of days of use of defined addictive medications/month

    Time frame: Within 2 weeks of admission

    No. days of use of any of the following: opiates, benzodiazepines, Z-hypnotics

  12. No. of possible side effects

    Time frame: Within 2 weeks of admission

    No. possible side effects of any of the following: opiates, benzodiazepines, Z-hypnotics

  13. No. of possible serious interactions

    Time frame: Within 2 weeks of admission

    No. possible serious interactions of any of the following: opiates, benzodiazepines, Z-hypnotics

  14. No.of inappropriate medications for elderly at admission

    Time frame: Within 2 weeks of admission

    No.of inappropriate medications as defined by NORGEP criteria (Norwegian general practice criteria)

  15. No.of inappropriate medications for elderly during in-hospital stay

    Time frame: Within 2 weeks of admission

    No.of inappropriate medications as defined by NORGEP criteria

  16. No.of inappropriate medications for elderly at discharge

    Time frame: Within 2 weeks of admission

    No.of inappropriate medications as defined by NORGEP criteria

  17. No.of inappropriate medications for elderly at admission

    Time frame: Within 2 weeks of admission

    No.of inappropriate medications as defined by STOPP criteria (Screening tool of older patients prescriptions)

  18. No.of inappropriate medications for elderly during in-hospital stay

    Time frame: Within 2 weeks of admission

    No.of inappropriate medications as defined by STOPP criteria

  19. No.of inappropriate medications for elderly at discharge

    Time frame: Within 2 weeks (index stay may in some cases be somewhat longer)

    No.of inappropriate medications as defined by STOPP criteria

  20. Substance use disorder

    Time frame: Within 2 weeks

    DSM-IV criteria assessed through additional questions to MINI interview

Other outcomes

  1. Mortality

    Time frame: 2 years

    Crude mortality from patient registry data

  2. Mortality

    Time frame: 5 years

    Crude mortality from patient registry data

  3. Readmission rate

    Time frame: 5 years

    Number of readmissions after index admission

  4. Total readmission days

    Time frame: 5 years

    Total number of readmission days

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • King's College London
  • University of Oslo

Registry information

Official study title

Medication Misuse and Dependence in Elderly Patients

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
May 22, 2017
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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