Prevalence of Hazardous Alcohol Use in a Population With Hypertension in Primary Care

NCT05580549 | Unknown

• 1 other identifier: SLSO2022-0143
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cross-sectional study is to map the prevalence of hazardous alcohol use in 270 adult patients with hypertension in Primary Health Care (PHC). The main question it aims to answer is: What is the prevalence of hazardous alcohol use in a population with hypertension in primary care detected with PEth and AUDIT, analysed in relation to patients with controlled, uncontrolled and treatment resistant hypertension? Participants will, in conjunction with annual control of hypertension with a General Practitioner (GP) at their Primary Health Care Centre (PHCC), visit a study nurse. The study nurse will collect following data: • Physical measurements• Lifestyle habits• Quality of life and demographic data • Drugs for hypertension and comorbidity • Laboratory tests including Phosphatidylethanol (PEth).

Conditions

Hypertension; Alcohol Drinking; Alcohol Use, Unspecified

Keywords

Phosphatidylethanol; Alcohol Use Disorders Identification Test (AUDIT); Primary Health Care; Health promotion

Outcome Measures

Primary Outcomes (2)

• Hazardous alcohol use

  Measured PEth-value. Defined as \> 0,3 µmol/L on PEth.

  baseline

• Hazardous alcohol use

  Selfreported values. Defined as 6-13 points for women and 8-15 points for men on Alcohol Use Disorders Identification Test (AUDIT).

  Baseline

Study Arms (1)

Essential Hypertension

A representative sample of adult patients, with hypertension (ICD-10 diagnose code I10.9) from 2-3 PHCC in Stockholm Region, Sweden. Age 30-85 years old.

Diagnostic Test: Alcohol biomarker Phosphatidylethanol (PEth)

Interventions

Alcohol biomarker Phosphatidylethanol (PEth) DIAGNOSTIC_TEST

The prevalence of hazardous alcohol use will be mapped through the biomarker PEth and the questionnaire AUDIT.

Also known as: Alcohol Use Disorders Identification Test (AUDIT)

Essential Hypertension

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From 2-3 PHCCs, in Stockholm region in Sweden, we will find patients with the extraction tool Medrave4. Patients with hypertension from the last two years will be extracted and the criteria for inclusion will be applied. A stratified and random sample will be created of three different groups of hypertension: Controlled, Uncontrolled and, Treatment resistant hypertension.

You may qualify if:

• Hypertension ICD-10 code I10.9.
• Age 30-85 years.

You may not qualify if:

• Not able to come to the primary health care centre
• Not understanding swedish
• Not speaking swedish
• Severe disease
• Dementia
• Serious mental illness

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• Forte: collaborator
• Sophiahemmet University: collaborator

Study Sites (1)

Region Stockholm

Stockholm, 10431, Sweden

RECRUITING

Related Publications (21)

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Related Links

• The National Board of Health and Welfare 2018: National guidelines for disease prevention methods
• The Central Association for Alcohol and Narcotic Information (CAN): Self-reported alcohol habits in Sweden 2004-2020. CAN report 204

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood fats (P-Cholesterol, P-HDL, P-LDL, fP-Triglycerides) Glucose (fP-glucose) Blood status (B-Hemoglobin, B-EVF, B-MCV, B-MCH, B-MCHC, B-Leucocytes, B-Thrombocytes Kidney function (P-Creatinine, P-Potassium, U-Albumin/Creatinine, Pt-eGFR) Phosphatidylethanol ( B-PEth 16:0/18:1)

MeSH Terms

Conditions

Hypertension; Alcohol Drinking

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Drinking Behavior; Behavior

Study Officials

• Lena Lund, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Lund, PhD

CONTACT

+46701655182; lena.lund@ki.se

Åsa Thurfjell, MD

CONTACT

asa.thurfjell@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)