Medication Misuse and Dependence Among Elderly

August 30, 2024 updated by: Christofer Lundqvist, University Hospital, Akershus

Medication Misuse and Dependence in Elderly Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lørenskog, Norway
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 90 years (Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dependence y/n
Time Frame: Within 2 weeks of admission
DSM-IV defined substance dependence assessed by MINI interview
Within 2 weeks of admission
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
Past year prior to in-hospital stay (data collected within 2 weeks of admission)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MCI - Mild cognitive impairment
Time Frame: Within 2 weeks of admission
Defined by MMSE < 26
Within 2 weeks of admission
MMSE
Time Frame: Within 2 weeks of admission
Numerical score of cognitive function
Within 2 weeks of admission
COGNISTAT
Time Frame: Within 2 weeks of admission
Cognitive profile
Within 2 weeks of admission
EQ-5D
Time Frame: Within 2 weeks of admission
Quality of life
Within 2 weeks of admission
BIS-11
Time Frame: Within 2 weeks of admission
Impulsivity score
Within 2 weeks of admission
BIS/BAS score
Time Frame: Within 2 weeks of admission
Behavioura inhibition/activation score
Within 2 weeks of admission
TUG
Time Frame: Within 2 weeks of admission
Functional test score (time in secs)
Within 2 weeks of admission
SLB
Time Frame: Within 2 weeks of admission
Functional test score (time in secs)
Within 2 weeks of admission
Neuropsychological profiles
Time Frame: Within 2 weeks of admission
Tests as listed
Within 2 weeks of admission
Use of addictive medication y/n
Time Frame: Within 2 weeks of admission
Prescription use of any of the following: opiates, benzodiazepines, Z-hypnotics
Within 2 weeks of admission
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
Within 2 weeks of admission
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
Within 2 weeks of admission
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
Within 2 weeks of admission
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)
Within 2 weeks of admission
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
Within 2 weeks of admission
No.of inappropriate medications for elderly at discharge
Time Frame: Within 2 weeks of admission
No.of inappropriate medications as defined by NORGEP criteria
Within 2 weeks of admission
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)
Within 2 weeks of admission
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
Within 2 weeks of admission
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
Within 2 weeks (index stay may in some cases be somewhat longer)
Substance use disorder
Time Frame: Within 2 weeks
DSM-IV criteria assessed through additional questions to MINI interview
Within 2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 2 years
Crude mortality from patient registry data
2 years
Mortality
Time Frame: 5 years
Crude mortality from patient registry data
5 years
Readmission rate
Time Frame: 5 years
Number of readmissions after index admission
5 years
Total readmission days
Time Frame: 5 years
Total number of readmission days
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Akershus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
University of Oslo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jorunn Rugkåsa, PhD, Coordinator of overall research program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRC256431WP2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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