Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2017-05-03
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
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
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
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
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
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
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
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)
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
65 Years
90 Years
ALL
No
Sponsors
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King's College London
OTHER
University of Oslo
OTHER
University Hospital, Akershus
OTHER
Responsible Party
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Christofer Lundqvist
Principal investigator
Principal Investigators
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Jorunn Rugkåsa, PhD
Role: STUDY_DIRECTOR
Coordinator of overall research program
Locations
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Akershus University Hospital
Lørenskog, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NRC256431WP2
Identifier Type: -
Identifier Source: org_study_id
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