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

NCT06067178 | Unknown

• 1 other identifier: NSV22252
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure (mmHg)

  Measured by care providers in accordance with routine guidelines

  Baseline (defined as time of HDI/OS), 6 months post intervention, 12 months post intervention

Other Outcomes (14)

• Change in blood cholesterol levels

  Baseline, 6 months post intervention, 12 months post intervention

• Change in blood glucose levels

  Baseline, 6 months post intervention, 12 months post intervention

• Change in body-mass-index

  Baseline, 6 months post intervention, 12 months post intervention

Study Arms (2)

Health Dialogue Intervention

EXPERIMENTAL

Behavioral: Health Dialogue Intervention

Opportunistic Screening

EXPERIMENTAL

Other: Opportunistic Screening

Interventions

Health Dialogue Intervention BEHAVIORAL

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.

Health Dialogue Intervention

Opportunistic Screening OTHER

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.

Opportunistic Screening

Eligibility Criteria

• Age: 50 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary care centres with a Care Need Index above 1.0
• Patients listed at the participating primary care centers.

You may not qualify if:

• None.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Center for epidemiology and community medicine, Region Stockholm

Stockholm, 10435, Sweden

Location

Related Publications (1)

• Ballin M, Backman Enelius M, Dini S, Galanti MR, Hagstromer M, Heintz E, Lager A, de Leon AP, Lundh L, Nystrand C, Walldin C, Augustsson H. Health dialogue intervention versus opportunistic screening in primary care for type 2 diabetes and cardiovascular disease prevention in settings with low socioeconomic status (DETECT): study protocol for a pragmatic cluster-randomized trial. Trials. 2024 Oct 12;25(1):672. doi: 10.1186/s13063-024-08533-8.

  PMID: 39394167 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hanna Augustsson, PhD

  Center for epidemiology and community medicine, Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pragmatic, cluster-randomized trial

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)