Medication Misuse and Dependence Among Elderly

Mild Cognitive Impairment Clinical Trial

Official title:

Medication Misuse and Dependence in Elderly Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03162081
• Other study ID #: NRC256431WP2
• Status: Active, not recruiting
• Start date: May 3, 2017
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Elderly
• Mild Cognitive Impairment
• Substance-Related Disorders

Intervention

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)
• EQ-5D
Health related Quality of life
• Impulsivity screening
Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test
• Cognitive screening
Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test
• Functional tests
Timed up and go (TUG), Single leg balancing test (SLB)
• Cognistat
Assessment of cognitive domains
• 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
• Medication use
Detailed screen of used medications, interactions, side effects in electronic patient registry
• Comorbidity
Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	King's College London, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Crude mortality from patient registry data	2 years
Other	Mortality	Crude mortality from patient registry data	5 years
Other	Readmission rate	Number of readmissions after index admission	5 years
Other	Total readmission days	Total number of readmission days	5 years
Primary	Dependence y/n	DSM-IV defined substance dependence assessed by MINI interview	Within 2 weeks of admission
Primary	Medication misuse y/n	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	MCI - Mild cognitive impairment	Defined by MMSE < 26	Within 2 weeks of admission
Secondary	MMSE	Numerical score of cognitive function	Within 2 weeks of admission
Secondary	COGNISTAT	Cognitive profile	Within 2 weeks of admission
Secondary	EQ-5D	Quality of life	Within 2 weeks of admission
Secondary	BIS-11	Impulsivity score	Within 2 weeks of admission
Secondary	BIS/BAS score	Behavioura inhibition/activation score	Within 2 weeks of admission
Secondary	TUG	Functional test score (time in secs)	Within 2 weeks of admission
Secondary	SLB	Functional test score (time in secs)	Within 2 weeks of admission
Secondary	Neuropsychological profiles	Tests as listed	Within 2 weeks of admission
Secondary	Use of addictive medication y/n	Prescription use of any of the following: opiates, benzodiazepines, Z-hypnotics	Within 2 weeks of admission
Secondary	No of days of use of defined addictive medications/month	No. days of use of any of the following: opiates, benzodiazepines, Z-hypnotics	Within 2 weeks of admission
Secondary	No. of possible side effects	No. possible side effects of any of the following: opiates, benzodiazepines, Z-hypnotics	Within 2 weeks of admission
Secondary	No. of possible serious interactions	No. possible serious interactions of any of the following: opiates, benzodiazepines, Z-hypnotics	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly at admission	No.of inappropriate medications as defined by NORGEP criteria (Norwegian general practice criteria)	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly during in-hospital stay	No.of inappropriate medications as defined by NORGEP criteria	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly at discharge	No.of inappropriate medications as defined by NORGEP criteria	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly at admission	No.of inappropriate medications as defined by STOPP criteria (Screening tool of older patients prescriptions)	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly during in-hospital stay	No.of inappropriate medications as defined by STOPP criteria	Within 2 weeks of admission
Secondary	No.of inappropriate medications for elderly at discharge	No.of inappropriate medications as defined by STOPP criteria	Within 2 weeks (index stay may in some cases be somewhat longer)
Secondary	Substance use disorder	DSM-IV criteria assessed through additional questions to MINI interview	Within 2 weeks