Cardiovascular Diseases Clinical Trial
Official title:
Early Detection and Prevention of Lifestyle Related Diseases - a Pilot Study
The continuously increasing prevalence of cardiovascular diseases, type-2 diabetes, and COPD
is a major health problem in developed countries and is mainly caused by an unhealthy
lifestyle. Most important lifestyle related causes of morbidity and mortality are smoking,
obesity and physical inactivity, and increasing rates of obesity and physical inactivity in
combination with smoking will lead to an increase in the number of patients with lifestyle
related diseases in the coming decades. There is, therefore, an urgent need to identify and
establish strategies and to implement interventions, allowing for the identification and
management of citizens at increased risk of disease.
Two recent systematic reviews of general practice based health checks suggest that people at
increased risk of a chronic disease may benefit from a targeted approach to health checks.
Targeted or selective preventive actions are a generally accepted and well integrated part of
the health care system (e.g. treatment of hypertension and hyperlipidemia). However,
selective prevention is challenged in terms of how to identify citizens at increased risk of
disease in the general population in order to start the indicated preventive actions.
The aim of the present pilot study is to test the acceptability, feasibility and short-term
effect of a selective preventive program that systematically helps citizens evaluate
individual risk of lifestyle related disease and offers targeted and coordinated preventive
services in the primary health care sector.
The intervention comprises four elements: 1) Systematic collection of information on
lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk
groups based on questionnaire data and information from the electronic patient record (EPR)
using validated risk estimation models, 3) An individual electronic health profile with
personalized advise on lifestyle change and 4) targeted preventive services at the general
practitioner (GP) or the municipality for citizens at risk of lifestyle disease and citizens
with risk behavior, respectively.
The intervention is supported by a patient-centered health information system that
facilitates informed patient action and integrates general practice and municipality health
care providers.
Recruitment strategy:
The study is carried out in two municipalities in the Region of Southern Denmark (Haderslev
and Varde municipality. Total number of inhabitants: 98.925). All general practitioners in
the two municipalities (n=68) have been invited, and a total of 47 have agreed to participate
in the study. A total of 200 citizens born 1957-1986 are selected from the patient list of
each participating GP. Before selection, the citizens are stratified into households, and
subsequently households are randomly selected until the total number of citizens per enrolled
GP reaches 200. In selection of households the proportion of citizens living alone and the
proportion of citizens living with one or more potential participants is taken into account.
No disease-related criteria for excluding a citizen are defined prior to the study. The
selected citizens are invited to participate and asked to sign a declaration of consent.
Risk stratification and preventive services offered:
Enrolled participants receive a 15-item questionnaire on lifestyle, familiar disposition of
lifestyle disease and selected symptoms. From the individual electronic patient records (EPR)
at the GP information on diagnoses and treatment of COPD, type-2 diabetes, hyperlipidemia,
hypertension and ischemic heart disease are drawn. Based on questionnaire and EPR data the
participants are stratified into four groups: 1) Citizens with an already diagnosed lifestyle
related disease, 2) Citizens with an increased risk of lifestyle related disease, 3) Citizens
with risk behavior and 4) Citizens with a healthy lifestyle.
Citizens in group 1 are already being treated and/or receive behavioral interventions and are
therefore not the primary target of this study. Citizens in group 2 has a calculated
increased risk of lifestyle related disease(s) based on validated predictive models for risk
of COPD, type-2 diabetes and cardiovascular disease. The risk of COPD is calculated using the
COPD-PS screener algorithm taking into account information on age, total cigarette
consumption and respiratory symptoms. The risk of type-2 diabetes is calculated based on the
algorithm used in the Addition study including information on age, gender, BMI, history of
hypertension, physical activity and family history of diabetes. The cut-off value for being
at risk of type-2 diabetes, and COPD follows the recommendations of the two models. The risk
of cardiovascular disease is calculated using the Heart Score BMI score based on information
about age, gender, smoking status and BMI. An increased risk of cardiovascular disease is
defined in citizens with a ≥5% risk of dying of cardiovascular disease within the next 10
years. Citizens in group 2 are offered a preventive program at the GP including an initial
health examination and subsequent behavior counselling. Citizens in group 3 are defined by
having a BMI>35, being daily smoker, having a high risk alcohol consumption, having unhealthy
eating habits and/or low physical activity. Evaluation of eating habits is based on the
recommendations in the Swedish National Guidelines on Disease Prevention, and evaluation of
alcohol consumption and physical activity is based on recommendations from the Danish Health
Authority. Citizens in group 3 are offered behavior counselling in the municipality and
community health services, if necessary. Citizens in group 4 are not offered any further
services.
Electronic health information system:
The intervention is supported by a patient-centered health information system that
facilitates informed patient action based on the predictive model for identification and
stratification of citizens to the appropriate care providers and that supports the initiation
and follow up of preventive care through the provision of health information resources,
decision aids, risk calculators, personalized motivational messages and integrates primary
care and municipality health care providers.
Common training course:
Before the study commences enrolled GPs, practice staff and health professionals from the
municipalities are offered a common training course. The aim of the course is to train the
specific intervention elements and to improve the inter-sectoral knowledge and collaboration
on prevention of lifestyle diseases.
Evaluation:
Evaluation of the study will be carried out using quantitative as well as qualitative
research methods. Details on evaluation methods are included in section 9.
Results of the present pilot study will be used for the adjustment of the intervention prior
to a large scale study comprising 10 municipalities, up to 360 GPs and 200.000 citizens.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|