A prospective clinical trial of a multidisciplinary electronic cardiovascular prevention programme

ISRCTN	ISRCTN23940498
DOI	https://doi.org/10.1186/ISRCTN23940498
Protocol serial number	N/A
Sponsor	De Onderlinge Ziekenkas (Belgium)
Funder	De Onderlinge Ziekenkas (Belgium)

Submission date: 21/01/2007
Registration date: 06/03/2007
Last edited: 04/02/2014

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

Contact information

Prof Neree Claes
Scientific

University Hasselt
Faculty of Medicine-MMC
Agoralaan Building D
BE-3590
Diepenbeek
3590
Belgium

Phone	+32 (0)477291588
Email	neree.claes@uhasselt.be

Study information

Primary study design	Interventional
Study design	A prospective clinical trial with an intervention group and a matched control group
Secondary study design	Non randomised controlled trial
Scientific title
Study acronym	PreCardio
Study objectives	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(s)	Ethical Committee of University Hasselt, date of approval 18th January 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	23/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	350
Key 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
Key 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
Date of first enrolment	23/03/2007
Date of final enrolment	23/03/2010

Locations

Countries of recruitment

Belgium

Study participating centre

University Hasselt

Diepenbeek
3590
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013		Yes	No