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Medication Misuse and Dependence Among Elderly

Medication Misuse and Dependence in Elderly Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03162081
Enrollment
500
Registered
2017-05-22
Start date
2017-05-03
Completion date
2024-12-31
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Elderly, Substance-Related Disorders

Keywords

addiction, cognition, impulsivity, neuropsychology, prescription drug misuse, dependence

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.

Interventions

DIAGNOSTIC_TESTSubstance misuse screening

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)

DIAGNOSTIC_TESTEQ-5D

Health related Quality of life

DIAGNOSTIC_TESTImpulsivity screening

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

DIAGNOSTIC_TESTCognitive screening

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

DIAGNOSTIC_TESTFunctional tests

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

DIAGNOSTIC_TESTCognistat

Assessment of cognitive domains

DIAGNOSTIC_TESTNeuropsychological profiling

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

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

OTHERMedication use

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

OTHERComorbidity

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

Sponsors

King's College London
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication misuse y/nPast 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
Dependence y/nWithin 2 weeks of admissionDSM-IV defined substance dependence assessed by MINI interview

Secondary

MeasureTime frameDescription
MMSEWithin 2 weeks of admissionNumerical score of cognitive function
COGNISTATWithin 2 weeks of admissionCognitive profile
EQ-5DWithin 2 weeks of admissionQuality of life
BIS-11Within 2 weeks of admissionImpulsivity score
BIS/BAS scoreWithin 2 weeks of admissionBehavioura inhibition/activation score
TUGWithin 2 weeks of admissionFunctional test score (time in secs)
SLBWithin 2 weeks of admissionFunctional test score (time in secs)
Neuropsychological profilesWithin 2 weeks of admissionTests as listed
MCI - Mild cognitive impairmentWithin 2 weeks of admissionDefined by MMSE \< 26
No.of inappropriate medications for elderly during in-hospital stayWithin 2 weeks of admissionNo.of inappropriate medications as defined by NORGEP criteria
No.of inappropriate medications for elderly at dischargeWithin 2 weeks of admissionNo.of inappropriate medications as defined by NORGEP criteria
Substance use disorderWithin 2 weeksDSM-IV criteria assessed through additional questions to MINI interview
Use of addictive medication y/nWithin 2 weeks of admissionPrescription use of any of the following: opiates, benzodiazepines, Z-hypnotics
No of days of use of defined addictive medications/monthWithin 2 weeks of admissionNo. days of use of any of the following: opiates, benzodiazepines, Z-hypnotics
No. of possible side effectsWithin 2 weeks of admissionNo. possible side effects of any of the following: opiates, benzodiazepines, Z-hypnotics
No. of possible serious interactionsWithin 2 weeks of admissionNo. possible serious interactions of any of the following: opiates, benzodiazepines, Z-hypnotics
No.of inappropriate medications for elderly at admissionWithin 2 weeks of admissionNo.of inappropriate medications as defined by NORGEP criteria (Norwegian general practice criteria)

Other

MeasureTime frameDescription
Mortality2 yearsCrude mortality from patient registry data
Total readmission days5 yearsTotal number of readmission days
Readmission rate5 yearsNumber of readmissions after index admission

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026