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Enrolling by invitationNCT03395509VISPUpdated Feb 1, 2024

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

An observational study in Aging, Aortic Aneurysm, Abdominal and Hypertension, sponsored by Central Jutland Regional Hospital. Enrolling by invitation at 1 site in Denmark. Open to participants aged 67 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by Central Jutland Regional Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,500
Ages
67 Years to 67 Years
Sex
All
01

Study 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.)

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.

02

Conditions studied

  • Aging
  • Aortic Aneurysm, Abdominal
  • Hypertension
  • Mass Screening
  • Peripheral Arterial Disease
  • Arrythmia
  • Diabetes
  • Carotid Atherosclerosis

Keywords

  • Mass screening
  • cardiovascular disease
  • diabetes
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 4,500 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Central Jutland Regional Hospital is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
67 Years to 67 Years
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

There are no exclusion criteria.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

  2. Baseline prevalence of abdominal aortic aneurysm (AAA)

    Ultra sound examination (AP diameter (mm))

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

  3. Baseline prevalence of diabetes

    Bedside HbA1c

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

  4. Baseline prevalence of hypertension

    BP(mmhg)

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

  5. Baseline prevalence of cardiac arrythmia

    ECG

    Time frame: 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)

    Time frame: Inclusion will take place from sep. 2014 to sep. 2020

Secondary outcomes

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

    Socio-economic evaluation (national register data), QALY

    Time frame: 5 years after ending inclusion

07

Study locations

1 site
  • Cardiovascular research Center (KVC), Viborg Hospital
    Viborg, 8800, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2014 (actual). Primary completion is estimated for Aug 2027, 156 months after the start.

Of 67 non-industry observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 156 months is above that.

Counting every sponsor, half of 91 studies reached it within 48 months; a quarter within 24 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2017
First posted
Jan 10, 2018
StartActual
Aug 1, 2014
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2029
Last update
Feb 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03395509
Lead sponsor
Central Jutland Regional Hospital
Responsible party
Annette Langager Hoegh (MD, PhD, Associated professor, Central Jutland Regional Hospital) — Principal investigator
First posted
Jan 10, 2018
Start date
Aug 1, 2014
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Feb 1, 2024

Study contacts

Annette Høgh, MD, PhD
study chair · Steering Committee
Marie Dahl, MSc(nurse)
study director · Steering Committee

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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