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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
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Annette Langager Hoegh, Central Jutland Regional Hospital

Brief 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.)

Condition or disease
Aging Aortic Aneurysm, Abdominal Hypertension Mass Screening Peripheral Arterial Disease Arrythmia Diabetes Carotid Atherosclerosis

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  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 Outcome Measures :
  1. The cost(-effectiveness) of the screening program [ Time Frame: 5 years after ending inclusion ]
    Socio-economic evaluation (national register data), QALY



Information from the National Library of Medicine

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Ages Eligible for Study:   67 Years to 67 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

There are no exclusion criteria.


Information from the National Library of Medicine

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


Locations
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Denmark
Cardiovascular research Center (KVC), Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Central Jutland Regional Hospital
Odense University Hospital
Investigators
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Study Chair: Annette Høgh, MD, PhD Steering Committee
Study Director: Marie Dahl, MSc(nurse) Steering Committee
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Responsible Party: Annette Langager Hoegh, MD, PhD, Associated professor, Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT03395509    
Other Study ID Numbers: VISP-dk
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Annette Langager Hoegh, Central Jutland Regional Hospital:
Mass screening
cardiovascular disease
diabetes
Additional relevant MeSH terms:
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Carotid Artery Diseases
Atherosclerosis
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Aneurysm
Arteriosclerosis
Arterial Occlusive Diseases
Aortic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases