Sociodemographic Factors and Criminal Behaviour Preceding Neurodegenerative Disease - Retrospective Register Study (DEGERWD)
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ClinicalTrials.gov Identifier: NCT06209515 |
Recruitment Status :
Active, not recruiting
First Posted : January 17, 2024
Last Update Posted : January 31, 2024
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In this retrospective register study, clinically classified individuals with neurodegenerative disease from the years 2010-2021 will be verified from the clinical records from KUH and Oulu University Hospital (OUH). Based on the Finnish social security number, these individuals will be linked to the the national registers of Statistics Finland and Finnish Social and Health Data Permit Authority Findata including incomes, sociodemographic factors, education, occupation, criminal records as well as to the national registers including the bought pharmaceuticals, comorbidities and causes of death. For each study case, 10 randomly selected control cases, matched with age, sex and geographical area, will be used.
The aim of the study is to examine:
- 1) The prevalence of criminal and other disruptive behaviour in groups of different neurodegenerative diseases prior to and after the diagnosis
- 2) Changes in employment, residency,income, and marital status prior to and after the neurodegenerative disease diagnosis
- 3) Hospital diagnoses and reimbursable drugs prior to and after the diagnosis
- 4) Causes of death in patients with neurodegenerative disease to study excess mortality of the patients
Condition or disease |
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Neurodegenerative Diseases Alzheimer Disease Frontotemporal Dementia Lewy Body Disease Vascular Dementia Parkinson Disease Progressive Supranuclear Palsy Corticobasal Degeneration Multiple System Atrophy Amyotrophic Lateral Sclerosis Huntington Disease |
Study Type : | Observational |
Estimated Enrollment : | 61292 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Sociodemographic Factors and Criminal Behaviour Preceding Neurodegenerative Disease - Retrospective Register Study |
Actual Study Start Date : | January 1, 2022 |
Estimated Primary Completion Date : | December 31, 2027 |
Estimated Study Completion Date : | December 31, 2027 |
Group/Cohort |
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Patients with neurodegenerative disease
Patient diagnosed with neurodegenerative disease (ICD-10 diagnosis code) between 2010-2021
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Matched controls
Age, gender, and place of residency matched for those of a patient that was alive at the end of the year of the diagnosis
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- Criminal behaviour: Type of offence, time of offence and other disruptive behaviour [ Time Frame: 1996-2020 ]Statistics Finland, Statistics on offences and coercive measures. Criminal behaviour is investigated utilising the reports of offences received by the police. The classification of offences is based on the three- or six-numbered offence classification by Statistics Finland, which enables the examination of different offences including e.g., violence, property, and traffic offences. The data extracted from the register include the type of the offence and time. Also, other disruptive behaviour based on the captures performed by the police (e.g., captures of intoxicated persons) is extracted.
- Socio-demographic data [ Time Frame: 1987-2021 ]Employment, residency, Income, Marital status. Socio-demographic outcome data is extracted from Statistics Finland, FOLK Basic data module. Possible changes in employment and residency are examined, and mortality and emigration will be considered as censoring factors
- Hospital diagnoses [ Time Frame: 1994-2021 ]Hospital diagnoses from the National Discharge Register. The National Discharge Register contains information of all hospitalizations after 1969, including ICD-8, ICD-9, and ICD-10 classifications to detect comorbidities of the patients. Two registers, "Terveydenhuollon hoitoilmoitusrekisteri (Hilmo)" and "Perusterveydenhuollon avohoidon hoitoilmoitus (Avohilmo)" of the Finnish Institute for Health and Welfare are used.
- Medication use [ Time Frame: 1995-2021 ]Reimbursable drugs from the Social Insurance Institution of Finland (SII). Finnish residents are covered under the National Health Insurance (NHI) scheme run by the SII. SII maintains a nationwide registry of all patients, with dispensed reimbursable drugs 1995-, including opioids and neuropathic pain medications. Data of medication use, cost, and reimbursement data are gathered from the SII database.
- Causes of death [ Time Frame: 2010-2021 ]Causes of death from Statistics Finland. Statistics Finland maintains a registry of causes of death and death certificates, which are supplemented with data from the population information system of the Population Register Centre. Registry data are used to study excess mortality of the patients.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- The diagnosis of neurodegenerative disease (ICD-10) in KUH or OUH between the years 2010-2021
- Age, sex and residency matched controls (Every research patient has 10 controls matched by age, gender, and place of residency)
Exclusion Criteria:
- Patients will be divided into different diagnostic groups based on the accepted diagnostic criteria in use. If some of the formed groups contain less than 5 subjects, the disease group in question is excluded from the analyses in order to ensure the privacy protection of the subjects
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): NCT06209515
Finland | |
Kuopio University Hospital | |
Kuopio, Finland |
Responsible Party: | Kuopio University Hospital |
ClinicalTrials.gov Identifier: | NCT06209515 |
Other Study ID Numbers: |
DEGERWD |
First Posted: | January 17, 2024 Key Record Dates |
Last Update Posted: | January 31, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Alzheimer Disease Dementia Motor Neuron Disease Amyotrophic Lateral Sclerosis Huntington Disease Neurodegenerative Diseases Multiple System Atrophy Shy-Drager Syndrome Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Supranuclear Palsy, Progressive Dementia, Vascular Lewy Body Disease |
Corticobasal Degeneration Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Tauopathies Neurocognitive Disorders Mental Disorders Neuromuscular Diseases Spinal Cord Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |