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

Study Overview
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Brief Summary
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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?

Detailed Description
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DETECT (health Dialogue intErvention versus opporTunistic scrEening in primary Care for Type 2 diabetes and cardiovascular disease prevention) targets the challenges of primary prevention for individuals with low socioeconomic status by implementing and evaluating two preventive interventions, a Health Dialogue Intervention (HDI) and an Opportunistic Screening (OS), conducted in primary care, specifically targeting settings with low socioeconomic status. The interventions will focus on detecting risk factors for CVD and supporting changes in unhealthy lifestyle behaviors. The study is designed as a parallel cluster-randomized trial with two conditions, with primary care centers (PCCs) serving as the unit of randomization and individual patients as units of observation for primary and secondary outcomes. Participants randomized to the HDI intervention will be invited to partake in a systematic screening of cardiovascular and metabolic risk factors using questionnaires, blood sampling, and clinical examinations, all of which together form the risk profile. Next, they will be invited to an individually oriented health dialogue which is prescribed by a care provider. The dialogue focuses on promoting healthy lifestyle behaviors and is based on the screening results and the given risk profile. The effects of HDI will be compared to that from OS, wherein participants will be recruited upon scheduling of an appointment at their PCC for any reason, except for individuals with pre-scheduled appointments related to hypertension, T2D, and CVD. Participants receiving OS will be screened for hypertension, overweight/obesity, tobacco usage, blood-lipid profile, and blood glucose. Short-term outcomes will be assessed at baseline, and 6 and 12-months after receiving the intervention, and long-term outcomes (i.e. 5 and 10 years post intervention) using nationwide registers. The goal is to recruit a total of 30 PCCs (n=15 in each arm) in the county of Stockholm. Based on real observed variance in levels of systolic blood pressure in the county of Stockholm and accounting for clustering effects, the investigators calculate that a minimum of 840 participants (n=420 in each arm and n=28 per cluster) would yield 80% power to detect a reduction of 5 mmHg systolic blood pressure in the HDI group. To allow for the expected difficulties with recruitment and subsequent attrition, the investigators therefore aim to recruit n=100 patients per cluster, yielding a total study population of 3000. The data will be primarily analyzed according to an intention-to-treat approach; that is, individuals will be considered exposed to the intervention to which their PCC has been randomized. The two experimental groups will be compared to estimate the effectiveness. Intention-to-treat analyses will be complemented by per-protocol analyses, where the effects of the interventions will be estimated only among participants who will receive the intervention according to the protocol foreseen. Linear regression will be used to estimate differences at follow-up in the means of continuous outcomes, whereas logistic regression was used in the analysis of dichotomous outcomes. In the intention-to-treat analyses the investigators will also estimate the number needed to treat to achieve one unit of the projected change in the corresponding outcome as 1/ARR (absolute risk reduction). The hierarchical structure of the data due to the cluster design will be considered through the use of mixed regression models, with random effects at the PCC level and fixed effects at the intervention level.

Official Title
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Effectiveness of a Health Dialogue Intervention Versus Opportunistic Screening in Primary Care for Type 2 Diabetes and Cardiovascular Disease Prevention in Low Socioeconomic Settings - The DETECT Trial

Conditions
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Cardiovascular Diseases, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Health Dialogue Intervention
* Other: Opportunistic Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary care centres with a Care Need Index above 1.0 Patients listed at the participating primary care centers. Exclusion Criteria: • None.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, cluster-randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Dialogue Intervention<br> | Behavioral: Health Dialogue Intervention<br>* Lifestyle assessment: All participants fill out a questionnaire to assess behavioral risk factors for CVD and undergo blood tests for cholesterol and blood glucose. 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.<br>|
| Experimental: Opportunistic Screening<br> | Other: Opportunistic Screening<br>* 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. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |