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.
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
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.
- Conditions
- Aging, Aortic Aneurysm, Abdominal, Hypertension, Mass Screening, Peripheral Arterial Disease, Arrythmia
- 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.
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
Baseline prevalence of abdominal aortic aneurysm (AAA)
Ultra sound examination (AP diameter (mm))
Measured: Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of diabetes
Bedside HbA1c
Measured: Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of hypertension
BP(mmhg)
Measured: Inclusion will take place from sep. 2014 to sep. 2020
Baseline prevalence of cardiac arrythmia
ECG
Measured: Inclusion will take place from sep. 2014 to sep. 2020
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)
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.
- First posted10 Jan 2018
- Study start1 Aug 2014
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Annette Langager Hoegh, Central Jutland Regional Hospital
- Investigators
- Annette Høgh, MD, PhD, Study chair, Steering CommitteeMarie Dahl, MSc(nurse), Study director, Steering Committee
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 41436274Gras 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 40130283Andersen 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 39926308Dahl 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 38997668Hogh 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intersectional Screening Program for Diabetes and Cardiovascular Diseases Among 67-years Old Citizens of the Municipal of Viborg
- ClinicalTrials.gov ID
- NCT03395509
- Acronym / sponsor ID
- VISP / VISP-dk
- Conditions
- Aging, Aortic Aneurysm, Abdominal, Hypertension, Mass Screening, Peripheral Arterial Disease, Arrythmia
- Keywords
- Mass screening, cardiovascular disease, diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 67 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (1 listed)
- All Viborg municipality citizen are invited to the combined screening program around there 67th birthday.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
The cost(-effectiveness) of the screening program
Time frame: 5 years after ending inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 41436274Van 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.
- Derived from this study: PubMed 40130283Gras 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.
- Derived from this study: PubMed 39926308Andersen 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.
- Derived from this study: PubMed 38997668Dahl 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.
- Derived from this study: PubMed 36854592Hogh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annette Høgh, MD, PhD study chair
Steering Committee
Marie Dahl, MSc(nurse) study director
Steering Committee
1 site in 1 country: see every site and its status.
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.