EUROACTION - A European wide effort to raise the standards of preventive cardiology

ISRCTN	ISRCTN71715857
DOI	https://doi.org/10.1186/ISRCTN71715857
Secondary identifying numbers	N/A

Submission date: 05/07/2005
Registration date: 12/09/2006
Last edited: 04/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof David Wood
Scientific

5th Floor Laboratory Block
Imperial College
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Phone	+44 (0)20 8846 1258
Email	d.wood@imperial.ac.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	EUROACTION - A European wide effort to raise the standards of preventive cardiology
Study acronym	EUROACTION
Study objectives	The aim of the study is to raise standards of preventive cardiology in Europe by demonstrating that the recommended European lifestyle, risk factor and therapeutic goals in cardiovascular prevention are achievable and sustainable in everyday clinical practice. EUROACTION is organised as a cluster randomised controlled intervention trial. In each of six countries a pair of general hospitals (12 in total) and a pair of general practices (12 in total) are recruited. Hospitals and general practices are randomised within pairs to receive the EUROACTION programme or to be monitored for usual care. The proportion of patients and family members achieving the European lifestyle, risk factor and therapeutic goals in the EUROACTION programme will be compared with usual care at one year. On completion, the EUROACTION programme will be offered to national professional societies and heart foundations, as an evaluated practice model for preventive cardiology.
Ethics approval(s)	Ethics approval not yet gained as of 12th September 2006.
Health condition(s) or problem(s) studied	Coronary Heart Disease (CHD)
Intervention	EUROACTION brings together a multidisciplinary team, comprising cardiologists, general practitioners, specialist nurses, dieticians, and physiotherapists and physical activity specialists to show that the Guidelines can be followed and lifestyle, risk factor and therapeutic goals achieved.
Intervention type	Other
Primary outcome measure	Hospital arm: 1. Coronary patients: Proportions of patients achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 1.1. Smoking habit (self reported, breath carbon monoxide (CO) 1.2. Diet/nutrition (self reported, food habit questionnaire, 24 hour recall with analysis) 1.3. Physical activity (self reported, step counter, incremental shuttle walk test, international physical activity questionnaire) 1.4. Overweight/obesity (Body Mass Index [BMI], waist circumference) 1.5. Diabetes (known/new, fasting and random plasma glucose, glycated haemoglobin (Hb A1c), Glucose Tolerance Test (GTT) 1.6. Blood pressure (automatic sphygmomanometer) 1.7. Total cholesterol, High-Density Lipoprotein (HDL) cholesterol, triglycerides, calculated Low-Density Lipoprotein (LDL) cholesterol) 1.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, Angiotensin Converting Enzyme (ACE)-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs 2. Partners and first-degree relatives of patients with premature coronary disease living in the same household: Proportions of partners and first degree relatives achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 2.1. Smoking habit (self reported, breath CO) 2.2. Diet/nutrition (self reported, food habit questionnaire, 24 hour recall with analysis) 2.3. Physical activity (self reported, step counter, international physical activity questionnaire) 2.4. Overweight/obesity (BMI, waist circumference) 2.5. Diabetes (known/new, fasting and random plasma glucose, Hb A1c) 2.6. Blood pressure (automatic sphygmomanometer) 2.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol) 2.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, ACE-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs 3. First-degree relatives of patients with premature coronary disease not living in the same household: Proportions of first degree relatives achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 3.1. Smoking habit (self reported) 3.2. Diet/nutrition (self reported) 3.3. Physical activity (self reported) 3.4. Overweight/obesity (BMI) 3.5. Diabetes (known/new, fasting and random plasma glucose) 3.6. Blood pressure 3.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol 3.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, ACE-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs Primary Care: 1. High-risk individuals: Proportions of high risk individuals achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 1.1. Smoking habit (self reported, breath CO) 1.2. Diet/nutrition (self reported, food habit questionnaire) 1.3. Physical activity (self reported, step counter, Chester step test) 1.4. Overweight/obesity (BMI, waist circumference) 1.5. Diabetes (known/new, fasting and random plasma glucose, HBA1c) 1.6. Blood pressure (automatic sphygmomanometer) 1.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol 1.8. Prophylactic drug therapies: antiplatelets, ACE-inhibitors, lipid-lowering drugs, hypoglycaemic drugs, nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs 2. Partners of high-risk individuals living in the same household: Proportions of partners achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 2.1. Smoking habit (self reported, breath CO) 2.2. Diet/nutrition (self reported, food habit questionnaire) 2.3. Physical activity (self reported, step counter) 2.4. Overweight/obesity (BMI, waist circumference) 2.5. Diabetes (known/new, fasting and random plasma glucose, HbA1c) 2.6. Blood pressure (automatic sphygmomanometer) 2.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol 2.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, ACE-inhibitors, lipid-lowering drugs, hypoglycaemic drugs
Secondary outcome measures	Hospital arm: 1. Coronary patients: 1.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), compliance (self reported), health beliefs (health beliefs questionnaire), emotional state (global mood scale), illness perception (illness perception questionnaire), functional limitation (SF 36 questions) 1.2. Return to work 1.3. Service use 1.4. Health economics (EuroQoL questionnaire) 1.5. Cardiovascular events (recurrent nonfatal coronary and cardiovascular events and cardiovascular/total mortality) 2. Partners and first-degree relatives of patients with premature coronary disease living in the same household: 2.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), compliance (self reported), health beliefs (health beliefs questionnaire), emotional state (global mood scale), illness perception (illness perception questionnaire), functional limitation (SF 36 questions) 2.2. Service use 2.3. Health economics (EuroQoL questionnaire) 2.4. Cardiovascular events (recurrent nonfatal coronary and cardiovascular events and cardiovascular/total mortality) Primary Care: 1. High-risk individuals: 1.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), health beliefs and views about heart disease (health beliefs questionnaire), risk perception (risk perception questionnaire), functional limitation (SF 36 questions) 1.2. Service use 1.3. Health economics (EuroQoL questionnaire) 1.4. Cardiovascular events (nonfatal coronary and cardiovascular events and cardiovascular/total mortality) 2. Partners of high-risk individuals living in the same household: 2.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), health beliefs and views about heart disease (health beliefs questionnaire), risk perception (risk perception questionnaire), functional limitation (SF 36 questions) 2.2. Service use 2.3. Health economics (EuroQoL questionnaire) 2.4. Cardiovascular events (nonfatal coronary and cardiovascular events and cardiovascular/total mortality)
Overall study start date	08/04/2003
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	10,000
Key inclusion criteria	Hospital arm: 1. In- and out-hospital patients who meet the inclusion criteria and who agree to participate in the trial. Within each hospital (both intervention and usual care) all consecutive new patients with medical diagnosis of Coronary Heart Disease (CHD) (see below), men and women under 80 years of age, will be identified: 1.1. Acute coronary syndromes, unstable angina, non Q wave Myocardial Infarction (MI), Q wave MIb 1.2. Stable angina pectoris 2. Partners of patients living in the same household 3. First degree blood relatives of patients with premature CHD Primary Care arm: 1. High risk individuals who meet the following inclusion criteria and who agree to participate in the trial. Men and women, 50 years of age or older, but less than 80 years, without history of coronary heart disease were identified in three categories as follows: 1.1. High multifactorial risk individuals: CVD risk more than or equal to 5% over ten years (now or projected to age 60 years), according to the HeartScore risk estimation system 1.2. Antihypertensive and/or lipid-lowering therapies initiated in the last year 1.3. New or known diabetes diagnosed in the last three years 2. Partners of high-risk individuals living in the same household
Key exclusion criteria	Hospital arm: 1. Aged 80 years of age or older 2. Severe heart failure 3. Impaired cognitive function 4. Severe physical disability Primary Care arm: 1. Under 50 and over 80 years of age 2. Mentally or physically incapable
Date of first enrolment	08/04/2003
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

Denmark
England
France
Italy
Netherlands
Poland
Spain
Sweden
United Kingdom

Study participating centre

5th Floor Laboratory Block

London
W6 8RF
United Kingdom

Sponsor information

European Society of Cardiology (France)
Other

European Heart House
2035 Route des Colles
Les Templiers - BP 179
F-06903 Sophia Antipolis Cedex
Nice
F-06903
France

Phone	+33 4 92 94 76 00
Email	fheraud@escardio.org
Website	http://www.escardio.org
"ROR"	https://ror.org/02ahe3232

Funders

Funder type

Industry

European Society of Cardiology (France)
Private sector organisation / International organizations

Alternative name(s): ESC
Location: France

AstraZeneca International - unconditional educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/06/2008		Yes	No
Other publications	cost-effectiveness	11/10/2012		Yes	No
Results article		31/03/2022	04/04/2022	Yes	No

Editorial Notes

04/04/2022: Publication reference added.