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Medication Misuse and Dependence Among Elderly

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ClinicalTrials.gov Identifier: NCT03162081
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
King's College London
University of Oslo
Information provided by (Responsible Party):
Christofer Lundqvist, University Hospital, Akershus

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.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Elderly Substance-Related Disorders Diagnostic Test: Substance misuse screening Diagnostic Test: EQ-5D Diagnostic Test: Impulsivity screening Diagnostic Test: Cognitive screening Diagnostic Test: Functional tests Diagnostic Test: Cognistat Diagnostic Test: Neuropsychological profiling Other: Clinical interview Other: Medication use Other: Comorbidity

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Weeks
Official Title: Medication Misuse and Dependence in Elderly Patients
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Users

Elderly patients who use prescription benzodiazepines/Z-hypnotics or opiates

Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity

Diagnostic Test: Substance 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 Test: EQ-5D
Health related Quality of life

Diagnostic Test: Impulsivity screening
Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test

Diagnostic Test: Cognitive screening
Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test

Diagnostic Test: Functional tests
Timed up and go (TUG), Single leg balancing test (SLB)

Diagnostic Test: Cognistat
Assessment of cognitive domains

Diagnostic Test: Neuropsychological 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

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

Other: Medication use
Detailed screen of used medications, interactions, side effects in electronic patient registry

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

Non-users

Age and gender matched controls not using the above

Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity

Diagnostic Test: Substance 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 Test: EQ-5D
Health related Quality of life

Diagnostic Test: Impulsivity screening
Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test

Diagnostic Test: Cognitive screening
Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test

Diagnostic Test: Functional tests
Timed up and go (TUG), Single leg balancing test (SLB)

Diagnostic Test: Cognistat
Assessment of cognitive domains

Diagnostic Test: Neuropsychological 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

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

Other: Medication use
Detailed screen of used medications, interactions, side effects in electronic patient registry

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

Screening group

Patients over 65 admitted to hospital as in-patients

Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Medication use, Comorbidity

Diagnostic Test: Substance 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 Test: EQ-5D
Health related Quality of life

Diagnostic Test: Impulsivity screening
Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test

Diagnostic Test: Cognitive screening
Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test

Diagnostic Test: Functional tests
Timed up and go (TUG), Single leg balancing test (SLB)

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

Other: Medication use
Detailed screen of used medications, interactions, side effects in electronic patient registry

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All admitted elderly 65-90 years of age are screened, for case-control age and gender-matched pairs of Users and non-users will in addition be examined in depth with neuropsychological tests
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162081


Contacts
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Contact: Christofer Lundqvist, PhD +47-47278881 a.c.lundqvist@medisin.uio.no
Contact: Socheat Cheng, M.D. +47-45063936 socc@ahus.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: C Lundqvist, MD, PhD         
Principal Investigator: Christofer Lundqvist, MD, PhD         
Sub-Investigator: Socheat Cheng, MD         
Sponsors and Collaborators
University Hospital, Akershus
King's College London
University of Oslo
Investigators
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Study Director: Jorunn Rugkåsa, PhD Coordinator of overall research program

Additional Information:

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Responsible Party: Christofer Lundqvist, Principal investigator, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03162081     History of Changes
Other Study ID Numbers: NRC256431WP2
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christofer Lundqvist, University Hospital, Akershus:
addiction
cognition
impulsivity
neuropsychology
prescription drug misuse
dependence

Additional relevant MeSH terms:
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Cognitive Dysfunction
Substance-Related Disorders
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Chemically-Induced Disorders