The Intersectional Viborg Screening Program: Cost-(Effectiveness) of Screening for Diabetes and Cardiovascular Diseases (VISP)
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|ClinicalTrials.gov Identifier: NCT03395509|
Recruitment Status : Enrolling by invitation
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
|Condition or disease|
|Aging Aortic Aneurysm, Abdominal Hypertension Mass Screening Peripheral Arterial Disease Arrythmia Diabetes Carotid Atherosclerosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||4500 participants|
|Official Title:||Intersectional Screening Program for Diabetes and Cardiovascular Diseases Among 67-years Old Citizens of the Municipal of Viborg|
|Actual Study Start Date :||August 1, 2014|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2025|
- 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
- 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))
- Baseline prevalence of diabetes [ Time Frame: Inclusion will take place from sep. 2014 to sep. 2020 ]Bedside HbA1c
- Baseline prevalence of hypertension [ Time Frame: Inclusion will take place from sep. 2014 to sep. 2020 ]BP(mmhg)
- Baseline prevalence of cardiac arrythmia [ Time Frame: Inclusion will take place from sep. 2014 to sep. 2020 ]ECG
- 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)
- The cost(-effectiveness) of the screening program [ Time Frame: 5 years after ending inclusion ]Socio-economic evaluation (national register data), QALY
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395509
|Cardiovascular research Center (KVC), Viborg Hospital|
|Viborg, Denmark, 8800|
|Study Chair:||Annette Høgh, MD, PhD||Steering Committee|
|Study Director:||Marie Dahl, MSc(nurse)||Steering Committee|