Contact information
Type
Scientific
Primary contact
Prof Neree Claes
ORCID ID
Contact details
University Hasselt
Faculty of Medicine-MMC
Agoralaan Building D
BE-3590
Diepenbeek
3590
Belgium
+32 (0)477291588
neree.claes@uhasselt.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PreCardio
Study hypothesis
A multidisciplinary electronic cardiovascular prevention programme at GP and patient level will lead to changes in medical and cardiovascular risk factors resulting in a lower overall cardiovascular risk
Ethics approval
Ethical Committee of University Hasselt, date of approval 18th January 2007
Study design
A prospective clinical trial with an intervention group and a matched control group
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Prevention of Cardiovascular diseases
Intervention
1. Medical interventions by GPs: determination of cardiovascular risk using a new computer tool, medical interventions aimed at medical risk factors (e.g. hypertension, high blood glucose level, high cholesterol) and a reduction of overall risk, follow-up dependent on cardiovascular risk
2. Interventions aimed at behaviour change (physical activity, diet, smoking): personalised website with guidelines based on theories on behaviour change + multidisciplinary support based on prinicples from behaviour therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. The effects of medical and behavioural interventions on medical parameters such as systolic blood pressure, diastolic blood pressure, total blood cholesterol level, blood glucose level (HbA1c), overweight and obesity, BMI
2. The effects of medical and behavioural interventions on health related behaviour such as physical activity; fat; fruit and vegetable intake; and smoking behaviour
3. The effects of medical and behavioural interventions on overall cardiovascular risk mediated by changes in medical and/or behavioural risk factors
4. The proportion of study participants with a 10% reduction in systolic blood pressure with participants with hypertension
5. The proportion of study participants with a 10% reduction in diastolic blood pressure with participants with hypertension
6. The proportion of study participants with a 10% reduction in total cholesterol with patients with hypercholesterol
7. The proportion of study participants with a 10% reduction in HB1Ac with initial HB1Ac >7% (high risk)
8. The proportion study participants with a 10% reduction in weight with initial BMI >25 kg/m²
Secondary outcome measures
1. The incidence of cardiovascular events
2. Number and total costs of cardiovascular events leading to loss of productivity
3. The effects of medical and behavioural interventions on psychological constructs as stage of change, attitude towards behaviour, self-identity, perceived behavioural control, autonomous motivation, intention
4. The effects of medical and behavioural interventions on Health Related Quality of Life
5. The effects of social support on health related behaviour (physical activity, fat and fibre intake and smoking behaviour) and psychological constructs (stage of change, attitude towards behaviour, self-identity, perceived behavioural control, autonomous motivation, intention)
6. A cost-effectiveness analysis of the medical and behavioural interventions using incremental cost-effectiveness ratios
Overall trial start date
23/03/2007
Overall trial end date
23/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 25-65
2. Insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed
3. Inhabitants of Limburg
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
350
Participant exclusion criteria
People with a high cardiovascular risk are not excluded from the PreCardio-study, given the constant supervision GPs and a cardiologist involved in PreCardio. However, high risk participants are advised not to take part in certain rigourous training schemes available to the participants of the study
Recruitment start date
23/03/2007
Recruitment end date
23/03/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
University Hasselt
Diepenbeek
3590
Belgium
Sponsor information
Organisation
De Onderlinge Ziekenkas (Belgium)
Sponsor details
Louis Mettewielaan 64-76
BE-1080
Brussels
1080
Belgium
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
De Onderlinge Ziekenkas (Belgium)
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23725092
Publication citations
-
Results
Claes N, Jacobs N, Clays E, Schrooten W, De Bourdeaudhuij I, Comparing the effectiveness of two cardiovascular prevention programmes for highly educated professionals in general practice: a randomised clinical trial., BMC Cardiovasc Disord, 2013, 13, 38, doi: 10.1186/1471-2261-13-38.