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

October 18, 2022 updated by: Region Stockholm

Prevalence of Hazardous Alcohol Use in a Population With Hypertension in Primary Care Detected With PEth and AUDIT - Observational Cross-sectional Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypertension, tobacco smoking, and alcohol use are the three leading risk factors for global disease burden. Treatment of hypertensive disease is important for the prevention of atherosclerotic disease, atrial fibrillation, heart failure, stroke, and dementia. In Sweden 27 % of adults have hypertension and a majority are treated in PHC but only 37 % reach target blood pressure. Alcohol can be one factor behind the low number of goal completion of blood pressure level.

Prevalence of hazardous alcohol use in Sweden is between 10-30 % in adults. Alcohol has an important role for over 200 diagnoses. There is a causal and dose dependent relationship between blood pressure levels and regular alcohol intake. Previous studies have reported hypertension to be attributable to alcohol in a wide range, depending on for example population, sex, and cultural context. But studies about the prevalence of hazardous alcohol use in patients with hypertension is few or even lacking.

General Practitioners (GPs) miss to identify a majority (60-70%) of patients with hazardous alcohol use even though guidelines on hypertension include risk stratification and detection of harmful lifestyle and the fact that general practitioners find it important to talk about alcohol with their patients.

Alcohol Use Disorders Identification Test (AUDIT) is a validated screening test for hazardous and harmful use in PHC setting, although concerns have been raised to its sensitivity. GPs experience that patient underestimate their consumption and that AUDIT does not meet the requirements to be a useful tool to detect hazardous alcohol use and AUDIT is seldomly used in PHC.

The alcohol biomarker Phosphatidylethanol (PEth) has high sensitivity and specificity to detect alcohol use. PEth can detect chronic heavy consumption. PEth is one of the newest alcohol biomarkers, but despite promising characteristics of PEth it is not routinely applied in clinical practice. PEth is used in a variety of settings like addiction care, emergency rooms, treatment of HIV-patients and patients with liver disease. PEth has started to be used in PHC but few studies on the use of biomarkers for alcohol consumption have been carried out in PHC.

The Swedish National Board of Health and Welfare has presented methods to use for supporting patients to change hazardous alcohol use. First the GPs need to identify if the patient has hazardous alcohol use. To our knowledge studies on whether PEth is a useful tool to detect hazardous use in patients with hypertension, in a primary health care context, is scarce or missing.

Study design

Based on that 12% of the hypertensive patients is related to alcohol intake and a presumed prevalence of hazardous drinking of 15 % the required sample size, given an effect size of 21%, significance level 5%, and power of 80% using contingency tables with 2 degrees of freedom, the study will require 270 patients with an included 10 % to compensate for missing values.

To perform an effective recruitment of patients we will invite patients from three well-functioning PHCCs with approximately 15.000 listed patients. Criteria for well-functioning is stable management and staff, routines for handling hypertension as well as unhealthy life-style habits and ability to offer locals for the project. By using the tool Medrave4 all patients 30-85 years old with hypertension (ICD-10 diagnose code I10.9) will be extracted from the PHCCs. The patients will be stratified to three groups of hypertension: •Controlled (blood pressure < 140/90), •Uncontrolled (blood pressure ≥ 140/90) and, •Treatment resistant hypertension (≥ 140/90 with three or more drugs against hypertension). Strata groups will be randomised, and the patients will be invited top to bottom. Recruitment will stop when 30 patients from each group has been included.

The PHCCs operations manager invites patients by letter. Patients have the opportunity to register their interest in participating in the study by letter or phone. Patients can also notify that they do not wish to be contacted. After 2-3 weeks the study nurse calls the patients and ask if they want to participate. The study nurse makes an initial assessment of the inclusion and exclusion criteria over the phone.

At the visit with the study nurse the final assessment of inclusion and exclusion criteria will be made. Finally the patients will be included after written informed consent. At the visit following data will be collected and stored at the digital platform REDCap:• Physical measurements (Blood pressure, pulse, weight, height, and waist measurement) • Lifestyle habits ( Alcohol, tobacco, food, and physical activity) • Quality of life (EQ-5D-5L) •Comorbidity with relevance to hypertension (Diabetes type 1 or 2, atrial fibrillation, angina pectoris, heart failure, myocardial infarction, stroke, and Transient ischemic attack) • Socioeconomic data (year of birth, gender, education, employment, occupation, people in the household) • Drugs for hypertension (Beta blockers, Calcium blockers, Thiazides, ACE inhibitors, ARB blockers, and Potassium-sparing diuretic) • Blood- and urine tests for hypertension and Phosphatidylethanol (PEth).

Patients will then visit their GP for an usual annual control of hypertension. The patients will receive results of blood tests and if needed adjustment of treatment will be done. Study nurse and GPs will talk about life style factors, including alcohol, with the patient. If hazardous alcohol use they will give short advice and offer more support if the patient needs and wants it. Before the start of the study GPs from the PHCCs will attend a short education of how to interpret PEth and AUDIT.

Detection of hazardous alcohol use, by the two methods PEth and AUDIT, will be described in the three strata (controlled, uncontrolled and treatment resistant hypertension) of the whole cohort. We will adjust for possible confounders (lifestyle factors, socio-economic data and patients' perceived health). We will relate our calculations to established risk stratification models for cardiovascular disease. All patients with hypertension and the drop-out population will be analysed according to what is ethically possible. Usual statistical presentation methods based on the scale level of collected data and other properties will be used.

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 10431
        • Recruiting
        • Region Stockholm
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Åsa Thurfjell, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
The prevalence of hazardous alcohol use will be mapped through the biomarker PEth and the questionnaire AUDIT.
Other Names:
  • Alcohol Use Disorders Identification Test (AUDIT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazardous alcohol use
Time Frame: baseline
Measured PEth-value. Defined as > 0,3 µmol/L on PEth.
baseline
Hazardous alcohol use
Time Frame: Baseline
Selfreported values. Defined as 6-13 points for women and 8-15 points for men on Alcohol Use Disorders Identification Test (AUDIT).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet
Forte
Sophiahemmet University

Investigators

  • Principal Investigator: Lena Lund, PhD, Region Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLSO2022-0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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