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Enrolling by Invitation

NCT Number: NCT03395509

The Intersectional Viborg Screening Program: Cost-(Effectiveness) of Screening for Diabetes and Cardiovascular Diseases

This is an intersectional and interdisciplinary screening program in Viborg Municipality, including 67 years old citizens. This observational study will estimate the cost-effectiveness of a combined screening program for the following conditions: Abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, arrhythmia, and type-2-diabetes. Furthermore, the incidence of the outlined conditions will be described and so will the result of the intervention initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

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Key information

Conditions

Aging Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arrhythmias, Cardiac Arrythmia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Atherosclerosis Central Nervous System Diseases Cerebrovascular Disorders Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Mass Screening Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

67 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular research Center (KVC), Viborg Hospital

Viborg, 8800, Denmark

About this study

Description of the cohort: All Viborg municipality citizen are invited to the combined screening program around there 67th birthday. Participants with positive screening results are offered following up consultations and prophylactic interventions are initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

67 years-old citizens from the surrounding municipalities without the offer of the combined screening are used as a control group (1 case: 5 controls).

There are no exclusion criteria.

The screening examination includes: Blood pressure in both arms, ankle brachial blood pressure index (ABI), ultrasound for carotid plaque and abdominal aortic aneurysm, HbA1c and pulmonary function test. Furthermore, a questionnaire on lifestyle parameters, BMI, medical history, walking-related pain and self-rated quality of life (EQ-5D).

One year after the screening examination, the participants will receive a questionnaire in order to evaluate the effect from a participant perspective. The cost(-effectiveness) of the screening program will be estimated after 5 years based on prevalence of diseases, response rate, data extraction from nationwide registries and existing evidence of disease prevention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Viborg municipality citizen are invited to the combined screening program around there 67th birthday.

Exclusion criteria

There are no exclusion criteria.

Treatment and study plan

Primary outcomes

  1. Baseline prevalence of peripheral arterial disease (PAD) in men and women aged 67 years from a population screening study on the Municipal of Viborg.

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    Ankel Brachial Index

  2. Baseline prevalence of abdominal aortic aneurysm (AAA)

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    Ultra sound examination (AP diameter (mm))

  3. Baseline prevalence of diabetes

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    Bedside HbA1c

  4. Baseline prevalence of hypertension

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    BP(mmhg)

  5. Baseline prevalence of cardiac arrythmia

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    ECG

  6. Baseline prevalence of carotic plaques

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

    Ultra sound examination of A. carotis (IMT in mm)

Secondary outcomes

  1. The cost(-effectiveness) of the screening program

    Time frame: 5 years after ending inclusion

    Socio-economic evaluation (national register data), QALY

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

Intersectional Screening Program for Diabetes and Cardiovascular Diseases Among 67-years Old Citizens of the Municipal of Viborg

Acronym: VISP

Important dates

Study start
2014
Primary completion
2027
Study completion
2029
First posted
Jan 10, 2018
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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