Health Dialogue Intervention Versus Opportunistic Screening for Type 2 Diabetes and Cardiovascular Disease Prevention

Summary

Chronic diseases such as cardiovascular disease and diabetes type 2 are major causes of death worldwide. Preventive interventions can be delivered through primary care, as this is the first-line healthcare with which a considerable proportion of the population comes into contact every year. The goal of this cluster-randomized trial is to compare the effects of a Health Dialogue Intervention (HDI) to Opportunistic Screening (OS) in primary care among middle-aged adults with low socioeconomic status. The main questions it aims to answer are:

* What is the short-term change in cardiovascular risk factors, lifestyle behaviors, and perceived quality-of-life among participants offered HDI, as compared to participants offered OS?
* What is the long-term risk of ischemic heart disease, stroke, type 2 diabetes, and death due to cardiovascular disease or type 2 diabetes, among participants offered HDI, as compared to participants offered OS?

Conditions

• Cardiovascular Diseases
• Type 2 Diabetes

Interventions

BEHAVIORAL

Health Dialogue Intervention

1. Lifestyle assessment: All participants fill out a questionnaire to assess behavioral risk factors for CVD and undergo blood tests for cholesterol and blood glucose. 2. Lifestyle health dialogue: When presenting in person at the primary care center, blood pressure, BMI, and waist-hip ratio will be measured. The results from the questionnaire, blood tests, blood pressure, and body measurements will be summarized using a visual tool, in which risk factors are graded into risk levels to estimate CVD risk. The visual tool will then be used in the health dialogue to discuss risk factors. The health dialogue is conducted by a licensed healthcare professional who has been trained in the methodology. The dialogue will be conducted in a person-centered manner and will aim to motivate and support lifestyle behavior changes when needed. If necessary, medical treatment will be provided according to existing guidelines.

OTHER

Opportunistic Screening

1. Risk factor assessment: Opportunistic screening entails screening for risk factors (blood pressure, BMI, blood tests for cholesterol and blood glucose, and smoking) among patients visiting the primary care center for another reason. Screening is conducted by a healthcare professional at which the patient has an appointment. 2. Detected risk factors for CVD are treated according to the existing care programs and guidelines at the primary care center, which should always include lifestyle advice as the first intervention and medication if hypertension is established. In this intervention, there is a more limited assessment of behavioral risk factors; that is, patients are asked about smoking, but assessment of diet, physical activity, or alcohol consumption is not included in the opportunistic screening.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  lead OTHER_GOV

Principal Investigators

• Hanna Augustsson, PhD · Center for epidemiology and community medicine, Region Stockholm

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2025-04-30

Completion

2025-04-30

Countries

• Sweden

Study Locations