Medication Misuse and Dependence Among Elderly

NCT03162081 | Active Not Recruiting

• 1 other identifier: NRC256431WP2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Elderly; Substance-Related Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Dependence y/n

  DSM-IV defined substance dependence assessed by MINI interview

  Within 2 weeks of admission

• 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 Outcomes (20)

• MCI - Mild cognitive impairment

  Within 2 weeks of admission

• MMSE

  Within 2 weeks of admission

• COGNISTAT

  Within 2 weeks of admission

• EQ-5D

  Within 2 weeks of admission

• BIS-11

  Within 2 weeks of admission

Other Outcomes (4)

• Mortality

  2 years

• Mortality

  5 years

• Readmission rate

  5 years

Study Arms (3)

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 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

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 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

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 Test: EQ-5D; Diagnostic Test: Impulsivity screening; Diagnostic Test: Cognitive screening; Diagnostic Test: Functional tests; Other: Clinical interview; Other: Medication use; Other: Comorbidity

Interventions

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)

Non-users; Screening group; Users

EQ-5D DIAGNOSTIC_TEST

Health related Quality of life

Non-users; Screening group; Users

Impulsivity screening DIAGNOSTIC_TEST

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

Non-users; Screening group; Users

Cognitive screening DIAGNOSTIC_TEST

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

Non-users; Screening group; Users

Functional tests DIAGNOSTIC_TEST

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

Non-users; Screening group; Users

Cognistat DIAGNOSTIC_TEST

Assessment of cognitive domains

Non-users; Users

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

Non-users; Users

Clinical interview OTHER

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

Non-users; Screening group; Users

Medication use OTHER

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

Non-users; Screening group; Users

Comorbidity OTHER

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

Non-users; Screening group; Users

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• King's College London: collaborator
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Norway

Location

Related Publications (8)

• Bjelkaroy MT, Simonsen TB, Siddiqui TG, Cheng S, Grambaite R, Benth JS, Lundqvist C. Mortality and health-related quality of life in older adults with long-term use of opioids, z-hypnotics or benzodiazepines: a prospective observational study at 5 years follow-up. BMJ Open. 2024 Feb 21;14(2):e079347. doi: 10.1136/bmjopen-2023-079347.

  PMID: 38387984 DERIVED

• Bjelkaroy MT, Simonsen TB, Siddiqui TG, Halset S, Cheng S, Grambaite R, Benth JS, Gerwing J, Kristoffersen ES, Lundqvist C. Brief Intervention as a Method to Reduce Z-Hypnotic Use by Older Adults: Feasibility Case Series. JMIR Form Res. 2024 Feb 8;8:e51862. doi: 10.2196/51862.

  PMID: 38329779 DERIVED

• Bjelkaroy MT, Benth JS, Simonsen TB, Siddiqui TG, Cheng S, Kristoffersen ES, Lundqvist C. Measuring pain intensity in older adults. Can the visual analogue scale and the numeric rating scale be used interchangeably? Prog Neuropsychopharmacol Biol Psychiatry. 2024 Mar 2;130:110925. doi: 10.1016/j.pnpbp.2023.110925. Epub 2023 Dec 22.

  PMID: 38143014 DERIVED

• Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.

  PMID: 35239678 DERIVED

• Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.

  PMID: 34913326 DERIVED

• Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.

  PMID: 32718926 DERIVED

• Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. Sociodemographic, clinical and pharmacological profiles of medication misuse and dependence in hospitalised older patients in Norway: a prospective cross-sectional study. BMJ Open. 2019 Sep 5;9(9):e031483. doi: 10.1136/bmjopen-2019-031483.

  PMID: 31492795 DERIVED

• Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.

  PMID: 31234786 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Substance-Related Disorders; Behavior, Addictive; Impulsive Behavior; Prescription Drug Misuse

Interventions

Medication Errors; Comorbidity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Behavior; Drug Misuse

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jorunn Rugkåsa, PhD

  Coordinator of overall research program

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 22, 2017
• Study Start: May 3, 2017
• Primary Completion: February 1, 2021
• Study Completion: December 31, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)