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NCT03395509 Clinical Trial

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

Hypertension Clinical Trial

— VISP  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03395509
Other study ID # VISP-dk
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 1, 2014
Est. completion date August 1, 2029

Study information
Verified date January 2024
Source Central Jutland Regional Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.)

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 4500
Est. completion date August 1, 2029
Est. primary completion date August 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 67 Years to 67 Years
Eligibility Inclusion Criteria: All Viborg municipality citizen are invited to the combined screening program around there 67th birthday. Exclusion Criteria: There are no exclusion criteria.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Cardiovascular research Center (KVC), Viborg Hospital Viborg

Sponsors (2)
Lead Sponsor Collaborator
Central Jutland Regional Hospital Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline prevalence of peripheral arterial disease (PAD) in men and women aged 67 years from a population screening study on the Municipal of Viborg. Ankel Brachial Index Inclusion will take place from sep. 2014 to sep. 2020
Primary Baseline prevalence of abdominal aortic aneurysm (AAA) Ultra sound examination (AP diameter (mm)) Inclusion will take place from sep. 2014 to sep. 2020
Primary Baseline prevalence of diabetes Bedside HbA1c Inclusion will take place from sep. 2014 to sep. 2020
Primary Baseline prevalence of hypertension BP(mmhg) Inclusion will take place from sep. 2014 to sep. 2020
Primary Baseline prevalence of cardiac arrythmia ECG Inclusion will take place from sep. 2014 to sep. 2020
Primary Baseline prevalence of carotic plaques Ultra sound examination of A. carotis (IMT in mm) Inclusion will take place from sep. 2014 to sep. 2020
Secondary The cost(-effectiveness) of the screening program Socio-economic evaluation (national register data), QALY 5 years after ending inclusion
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