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AgingVISPNCT03395509

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

An observational study of Aging and Aortic Aneurysm, Abdominal, run by Central Jutland Regional Hospital at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 67 to 67 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Aortic Aneurysm, Abdominal, Hypertension
How many people
4,500 participants
Where
1 siteDenmark
Study dates
1 Aug 2014to 1 Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 67 to 67 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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).

Who may be able to join

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

Who cannot join

  • There are no exclusion criteria.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site
  • Cardiovascular research Center (KVC), Viborg Hospital

    Viborg, 8800

Other trials in Denmark

About this study

Official title: 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.)

Read the 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.

Keywords
Mass screening, cardiovascular disease, diabetes
Medical subject headings
Aortic Aneurysm, Abdominal, Hypertension, Peripheral Arterial Disease, Arrhythmias, Cardiac, Diabetes Mellitus, Carotid Artery Diseases, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Ankel Brachial Index

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

  2. Baseline prevalence of abdominal aortic aneurysm (AAA)

    Ultra sound examination (AP diameter (mm))

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

  3. Baseline prevalence of diabetes

    Bedside HbA1c

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

  4. Baseline prevalence of hypertension

    BP(mmhg)

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

  5. Baseline prevalence of cardiac arrythmia

    ECG

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

  6. Baseline prevalence of carotic plaques

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

    Measured: Inclusion will take place from sep. 2014 to sep. 2020

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

    Socio-economic evaluation (national register data), QALY

    Measured: 5 years after ending inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start1 Aug 2014
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395509
Sponsor's protocol ID
VISP-dk
Acronym
VISP
Status last verified
Jan 2024
First submitted
15 Mar 2017
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Van Der Giessen D, Hogh A, Svenstrup D, Lindholt JS, Dahl M. Clinical relevance of screening for ECG abnormalities in 67-year-old Danes: a population-based cohort study from the Viborg Screening Programme (VISP). BMJ Open. 2025 Dec 23;15(12):e104169. doi: 10.1136/bmjopen-2025-104169.

    PubMed 41436274
  • Gras Hojgaard H, Hogh AL, Lindholt JS, Frederiksen K, Dahl M. Effect of nurse-led telephone follow-up to optimize adherence to preventive medication after screen-detected cardiovascular disease: a randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Jul 21;24(5):748-759. doi: 10.1093/eurjcn/zvaf047.

    PubMed 40130283
  • Andersen JW, Hogh A, Lindholt JS, Sogaard R, Stovring H, Yderstraede KB, Sandbaek A, Dahl M. Impact of Population-Based Screening for Diabetes and Prediabetes Among 67-Year-Olds Using Point-of-Care HbA1c on Healthcare Ultilisation, Results from the VISP Cohort. Clin Epidemiol. 2025 Feb 5;17:75-85. doi: 10.2147/CLEP.S487825. eCollection 2025.

    PubMed 39926308
  • Dahl M, Andersen JW, Lindholt J, Krarup NT, Borregaard B, Uberg N, Hogh A. Prevalence of interarm blood pressure difference is notably higher in women; the Viborg population-based screening program (VISP). BMC Public Health. 2024 Jul 12;24(1):1868. doi: 10.1186/s12889-024-19388-8.

    PubMed 38997668
  • Hogh A, Lindholt JS, Sogaard R, Refsgaard J, Svenstrup D, Moeslund NJ, Bredsgaard M, Dahl M. Protocol for a cohort study to evaluate the effectiveness and cost-effectiveness of general population screening for cardiovascular disease: the Viborg Screening Programme (VISP). BMJ Open. 2023 Feb 28;13(2):e063335. doi: 10.1136/bmjopen-2022-063335.

    PubMed 36854592

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Aortic Aneurysm, Abdominal, run by Central Jutland Regional Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395509, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.

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VISP Clinical Trial NCT03395509 | AzTrials