NCT05865847

Brief Summary

This is a nationwide cohort study of Finnish adults aged 25 and older, who are followed up for the incidence of an alcohol-attributable hospitalization or death. The primary objective is to examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,950,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

May 3, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (18)

  • Alcohol intoxication - Hospitalization

    Incidence of alcohol intoxication hospitalization (ICD-10 F10.0-1)

    January 1, 2016 to February 28, 2020

  • Alcohol intoxication - Death

    Death due to alcohol intoxication (ICD-10 F10.0-1)

    January 1, 2016 to February 28, 2020

  • Alcohol dependence - Hospitalization

    Incidence of hospitalization due to alcohol dependence (F10.2)

    January 1, 2016 to February 28, 2020

  • Alcohol dependence - Death

    Death due to alcohol dependence (F10.2)

    January 1, 2016 to February 28, 2020

  • Psycho-organic syndrome caused by alcohol - Hospitalization

    Incidence of hospitalization due to psycho-organic syndrome caused by alcohol (F10.3-9)

    January 1, 2016 to February 28, 2020

  • Psycho-organic syndrome caused by alcohol - Death

    Death due to psycho-organic syndrome caused by alcohol (F10.3-9)

    January 1, 2016 to February 28, 2020

  • Alcoholic liver disease - Hospitalization

    Incidence of hospitalization due to alcoholic liver disease(K70)

    January 1, 2016 to February 28, 2020

  • Alcoholic liver disease - Death

    Death due to alcoholic liver disease(K70)

    January 1, 2016 to February 28, 2020

  • Pancreatic diseases caused by alcohol - Hospitalization

    Incidence of hospitalization due to pancreatic diseases caused by alcohol (K85.2, K86.0)

    January 1, 2016 to February 28, 2020

  • Pancreatic diseases caused by alcohol - Death

    Death due to pancreatic diseases caused by alcohol (K85.2, K86.0)

    January 1, 2016 to February 28, 2020

  • Gastritis caused by alcohol - Hospitalization

    Incidence of hospitalization due to gastritis caused by alcohol (K29.2)

    January 1, 2016 to February 28, 2020

  • Gastritis caused by alcohol - Death

    Death due to gastritis caused by alcohol (K29.2)

    January 1, 2016 to February 28, 2020

  • Alcoholic cardiomyopathy - Hospitalization

    Incidence of hospitalization due to alcoholic cardiomyopathy (I42.6)

    January 1, 2016 to February 28, 2020

  • Alcoholic cardiomyopathy - Death

    Death due to alcoholic cardiomyopathy (I42.6)

    January 1, 2016 to February 28, 2020

  • Nervous system disorders caused by alcohol - Hospitalization

    Incidence of hospitalization due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)

    January 1, 2016 to February 28, 2020

  • Nervous system disorders caused by alcohol - Death

    Death due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)

    January 1, 2016 to February 28, 2020

  • Alcohol poisoning - Hospitalization

    Incidence of hospitalization due to alcohol poisoning (T51, X45)

    January 1, 2016 to February 28, 2020

  • Alcohol poisoning - Death

    Death due to alcohol poisoning (T51, X45)

    January 1, 2016 to February 28, 2020

Study Arms (1)

Lowest income groups

Deciles of equivalized net household income. The method compares the whole socioeconomic distribution.

Other: Not applicable, this is an observational study

Interventions

Not applicable, this is an observational study

Lowest income groups

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All permanent residents in Finland older than 25 years old and without an alcohol-attributable hospital admission during the past three years

You may qualify if:

  • Permanent residents (defined by Statistics Finland as those Finnish and foreign nationals who have a legal domicile in Finland and intend to stay (or have stayed) for at least one year) alive in Finland by December 31, 2015
  • Age 25 years or older by January 1, 2016
  • Not having an alcohol-attributable hospitalization during the past three years ((January 2013-December 2015

You may not qualify if:

  • Temporary residents, including foreign nationals living in Finland for less than a year, asylum seekers who have not been granted a legal domicile, temporary migrant workers and Finnish nationals living temporarily abroad by December 31, 2015

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23.

    PMID: 30146330BACKGROUND
  • Manthey J, Hassan SA, Carr S, Kilian C, Kuitunen-Paul S, Rehm J. What are the Economic Costs to Society Attributable to Alcohol Use? A Systematic Review and Modelling Study. Pharmacoeconomics. 2021 Jul;39(7):809-822. doi: 10.1007/s40273-021-01031-8. Epub 2021 May 10.

    PMID: 33970445BACKGROUND
  • Room R, Ferris J, Laslett AM, Livingston M, Mugavin J, Wilkinson C. The drinker's effect on the social environment: a conceptual framework for studying alcohol's harm to others. Int J Environ Res Public Health. 2010 Apr;7(4):1855-71. doi: 10.3390/ijerph7041855. Epub 2010 Apr 21.

    PMID: 20617064BACKGROUND
  • Probst C, Lange S, Kilian C, Saul C, Rehm J. The dose-response relationship between socioeconomic deprivation and alcohol-attributable mortality risk-a systematic review and meta-analysis. BMC Med. 2021 Nov 5;19(1):268. doi: 10.1186/s12916-021-02132-z.

    PMID: 34736475BACKGROUND
  • Probst C, Kilian C, Sanchez S, Lange S, Rehm J. The role of alcohol use and drinking patterns in socioeconomic inequalities in mortality: a systematic review. Lancet Public Health. 2020 Jun;5(6):e324-e332. doi: 10.1016/S2468-2667(20)30052-9.

    PMID: 32504585BACKGROUND
  • Syden L, Sidorchuk A, Makela P, Landberg J. The contribution of alcohol use and other behavioural, material and social factors to socio-economic differences in alcohol-related disorders in a Swedish cohort. Addiction. 2017 Nov;112(11):1920-1930. doi: 10.1111/add.13889. Epub 2017 Jul 17.

    PMID: 28556302BACKGROUND
  • Makela P, Paljarvi T. Do consequences of a given pattern of drinking vary by socioeconomic status? A mortality and hospitalisation follow-up for alcohol-related causes of the Finnish Drinking Habits Surveys. J Epidemiol Community Health. 2008 Aug;62(8):728-33. doi: 10.1136/jech.2007.065672.

    PMID: 18621959BACKGROUND
  • Pena S, Makela P, Laatikainen T, Harkanen T, Mannisto S, Heliovaara M, Koskinen S. Joint effects of alcohol use, smoking and body mass index as an explanation for the alcohol harm paradox: causal mediation analysis of eight cohort studies. Addiction. 2021 Aug;116(8):2220-2230. doi: 10.1111/add.15395. Epub 2021 Jan 28.

    PMID: 33404149BACKGROUND
  • Katikireddi SV, Whitley E, Lewsey J, Gray L, Leyland AH. Socioeconomic status as an effect modifier of alcohol consumption and harm: analysis of linked cohort data. Lancet Public Health. 2017 May 10;2(6):e267-e276. doi: 10.1016/S2468-2667(17)30078-6. eCollection 2017 Jun.

    PMID: 28626829BACKGROUND
  • Makela P. Alcohol-related mortality as a function of socio-economic status. Addiction. 1999 Jun;94(6):867-86. doi: 10.1046/j.1360-0443.1999.94686710.x.

    PMID: 10665076BACKGROUND
  • Pena S, Makela P, Harkanen T, Heliovaara M, Gunnar T, Mannisto S, Laatikainen T, Vartiainen E, Koskinen S. Measurement error as an explanation for the alcohol harm paradox: analysis of eight cohort studies. Int J Epidemiol. 2021 Jan 23;49(6):1836-1846. doi: 10.1093/ije/dyaa113.

    PMID: 32995840BACKGROUND
  • Sadler S, Angus C, Gavens L, Gillespie D, Holmes J, Hamilton J, Brennan A, Meier P. Understanding the alcohol harm paradox: an analysis of sex- and condition-specific hospital admissions by socio-economic group for alcohol-associated conditions in England. Addiction. 2017 May;112(5):808-817. doi: 10.1111/add.13726. Epub 2017 Feb 6.

    PMID: 27981670BACKGROUND
  • Mackenbach JP, Kulhanova I, Bopp M, Borrell C, Deboosere P, Kovacs K, Looman CW, Leinsalu M, Makela P, Martikainen P, Menvielle G, Rodriguez-Sanz M, Rychtarikova J, de Gelder R. Inequalities in Alcohol-Related Mortality in 17 European Countries: A Retrospective Analysis of Mortality Registers. PLoS Med. 2015 Dec 1;12(12):e1001909. doi: 10.1371/journal.pmed.1001909. eCollection 2015 Dec.

    PMID: 26625134BACKGROUND
  • Mackenbach JP. Should we aim to reduce relative or absolute inequalities in mortality? Eur J Public Health. 2015 Apr;25(2):185. doi: 10.1093/eurpub/cku217. No abstract available.

    PMID: 25818489BACKGROUND

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sebastián Peña, MD, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR
  • Sonja Lumme, PhD

    Finnish Institute for Health and Welfare

    STUDY CHAIR
  • Päivikki Koponen, PhD

    Finnish Institute for Health and Welfare

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 19, 2023

Study Start

January 1, 2015

Primary Completion

February 28, 2020

Study Completion

September 30, 2023

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The investigators will share the harmonization protocol to define the variables and the statistical code. Individual participant data is available upon request at FinData, following national data protection procedures.