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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06209515
Other study ID # DEGERWD
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2027

Study information

Verified date January 2024
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 61292
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Finland Kuopio University Hospital Kuopio

Sponsors (1)

Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Criminal behaviour: Type of offence, time of offence and other disruptive behaviour 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. 1996-2020
Primary Socio-demographic data 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 1987-2021
Primary Hospital diagnoses 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. 1994-2021
Primary Medication use 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. 1995-2021
Primary Causes of death 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. 2010-2021
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