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

January 31, 2024 updated by: Annette Langager Hoegh, Central Jutland Regional Hospital

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

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.)

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Viborg, Denmark, 8800
        • Cardiovascular research Center (KVC), Viborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

67 years to 67 years (Older Adult)

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Inclusion will take place from sep. 2014 to sep. 2020
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))
Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of diabetes
Time Frame: Inclusion will take place from sep. 2014 to sep. 2020
Bedside HbA1c
Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of hypertension
Time Frame: Inclusion will take place from sep. 2014 to sep. 2020
BP(mmhg)
Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of cardiac arrythmia
Time Frame: Inclusion will take place from sep. 2014 to sep. 2020
ECG
Inclusion will take place from sep. 2014 to sep. 2020
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)
Inclusion will take place from sep. 2014 to sep. 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cost(-effectiveness) of the screening program
Time Frame: 5 years after ending inclusion
Socio-economic evaluation (national register data), QALY
5 years after ending inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Jutland Regional Hospital

Collaborators

Odense University Hospital

Investigators

  • Study Chair: Annette Høgh, MD, PhD, Steering Committee
  • Study Director: Marie Dahl, MSc(nurse), Steering Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISP-dk

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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