A prospective clinical trial of a multidisciplinary electronic cardiovascular prevention programme
| ISRCTN | ISRCTN23940498 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23940498 |
| Secondary identifying numbers | N/A |
- 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
Scientific
University Hasselt
Faculty of Medicine-MMC
Agoralaan Building D
BE-3590
Diepenbeek
3590
Belgium
| Phone | +32 (0)477291588 |
|---|---|
| neree.claes@uhasselt.be |
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Prevention |
| 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 | 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 study start date | 23/03/2007 |
| Completion date | 23/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
3590
Belgium
Sponsor information
De Onderlinge Ziekenkas (Belgium)
Industry
Industry
Louis Mettewielaan 64-76
BE-1080
Brussels
1080
Belgium
| Website | http://www.ozcm.be/ |
|---|
Funders
Funder type
Industry
De Onderlinge Ziekenkas (Belgium)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
