Condition category
Circulatory System
Date applied
21/01/2007
Date assigned
06/03/2007
Last edited
04/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ozcm.be/

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

  1. 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.

Additional files

Editorial Notes