Clinical trial NCT03395509: The Intersectional Viborg Screening Program: Cost-(Effectiveness) of Screening for Diabetes and Cardiovascular Diseases
Official title: Intersectional Screening Program for Diabetes and Cardiovascular Diseases Among 67-years Old Citizens of the Municipal of Viborg
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aging
Aortic Aneurysm, Abdominal
Hypertension
Mass Screening
Peripheral Arterial Disease
Arrythmia
Diabetes
Carotid Atherosclerosis
Keywords: Mass screening
cardiovascular disease
diabetes
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2018-01-10
Enrollment: 4500
Sex: ALL
Minimum age (years): 67
Maximum age (years): 67
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.)

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
measure: Baseline prevalence of abdominal aortic aneurysm (AAA)
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
measure: Baseline prevalence of diabetes
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
measure: Baseline prevalence of hypertension
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
measure: Baseline prevalence of cardiac arrythmia
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
measure: Baseline prevalence of carotic plaques
timeFrame: Inclusion will take place from sep. 2014 to sep. 2020
Secondary outcomes:
measure: The cost(-effectiveness) of the screening program
timeFrame: 5 years after ending inclusion
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Cardiovascular research Center (KVC), Viborg Hospital
Study officials:
affiliation: Steering Committee
name: Annette Høgh, MD, PhD
role: STUDY_CHAIR
affiliation: Steering Committee
name: Marie Dahl, MSc(nurse)
role: STUDY_DIRECTOR
References: