Condition category
Circulatory System
Date applied
05/07/2005
Date assigned
12/09/2006
Last edited
16/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.escardio.org/Policy/Pages/EuroAction.aspx

Contact information

Type

Scientific

Primary contact

Prof David Wood

ORCID ID

Contact details

5th Floor Laboratory Block
Imperial College
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)20 8846 1258
d.wood@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EUROACTION

Study hypothesis

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

Ethics approval not yet gained as of 12th September 2006.

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

08/04/2003

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant 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

Recruitment start date

08/04/2003

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Denmark, France, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom

Trial participating centre

5th Floor Laboratory Block
London
W6 8RF
United Kingdom

Sponsor information

Organisation

European Society of Cardiology (France)

Sponsor details

European Heart House
2035 Route des Colles
Les Templiers - BP 179
F-06903 Sophia Antipolis Cedex
Nice
F-06903
France
+33 4 92 94 76 00
fheraud@escardio.org

Sponsor type

Other

Website

http://www.escardio.org

Funders

Funder type

Industry

Funder name

European Society of Cardiology (France)

Alternative name(s)

ESC

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

France

Funder name

AstraZeneca International - unconditional educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18555911
2. 2012 cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/23065443

Publication citations

  1. Results

    Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O, , Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial., Lancet, 2008, 371, 9629, 1999-2012, doi: 10.1016/S0140-6736(08)60868-5.

  2. Mistry H, Morris S, Dyer M, Kotseva K, Wood D, Buxton M, , Cost-effectiveness of a European preventive cardiology programme in primary care: a Markov modelling approach., BMJ Open, 2012, 2, 5, doi: 10.1136/bmjopen-2012-001029.

Additional files

Editorial Notes