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Randomised controlled trial on the effects of a broad healthy life-style intervention to minimise the cardiovascular disease risk of individuals with Familial Hypercholesterolemia (FH)

Projectomschrijving

Iemand met Familiaire Hypercholesterolemie (FH) loopt een sterk verhoogde kans op een hart- en/of vaatziekte, vergeleken met iemand zonder FH. Dit onderzoek kijkt of het geven van leefstijladviezen de kans op een hart- en/of vaatziekte bij mensen met FH kan verlagen. De leefstijladviezen gaan over stoppen met roken, een gezond voedingspatroon, voldoende bewegen en therapietrouw met cholesterolverlagende medicijnen. Door loting werden 340 volwassenen met FH ingedeeld in een controlegroep en een interventiegroep. De interventie bestond uit advisering over leefstijl en was een combinatie van een advies op maat via het internet, een persoonlijk gesprek en meerdere telefoongesprekken. De controlegroep kreeg deze interventie niet. Na 12 maanden hebben we onder andere de concentratie LDL cholesterol in het bloed en de leefstijl gemeten. Er hebben 340 mensen met FH meegedaan aan het onderzoek. Momenteel zijn de laatste metingen afgerond en worden de effecten geanalyseerd.

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Samenvatting van de aanvraag

The Netherlands accounts for approximately 40,000 men, women and children with Familial Hypercholesterolaemia (FH). This most frequent dominant monogenetic disorder is causing a high LDL-cholesterol level, and thereby a seriously elevated risk of developing cardiovascular disease (CVD) at an early age. Without the correct diagnosis and treatment, 70% will suffer from a myocardial infarction before their 60th birthday. In 2003, the Dutch government decided to introduce a national programme for the detection of Dutch people with FH within the coming decade (the StOEH project). As a result, some tens of thousands of Dutch men, women and children will be notified that they have FH. Notification of belonging to this high-risk group must be followed rapidly by adequate treatment of biological and lifestyle risk factors. Improvement of lifestyle is likely to result in substantial health gains among the FH population, but this has never been studied. The present project therefore aims at examining the (cost-)effectiveness of an intensive 12 months personalised intervention to promote a healthy lifestyle (no smoking, proper nutritional pattern, sufficient physical activity, compliance to pharmaceutical therapy). To this end, 400 individuals that have been notified recently about their FH-positive status will be randomised to either receive or not receive a personalised health coaching intervention which is a combination of person-to person, telephone, brochures and web-based counselling based on principles of motivational interviewing, behavioural and normative feedback, and teaching of specific behavioural change skills. The intervention aims at getting the CVD risk as low as possible by attaining specific lifestyle improvements. The ultimate goal is proper self-management of risk factors. The intervention will be provided by a lifestyle counsellor, who pays a visit to the individuals randomised to the intervention group. In addition to this visit, that will be informative for both the study participant and his or her household members, incentives that facilitate healthy lifestyle behaviours -of the study participant and his or her household members- will be sent to the participants, telephone communication between the counsellor and the participants in the intervention group will be scheduled, and web-based counselling will be initiated and monitored. The effectiveness of the intervention will be evaluated on the basis of attained changes in LDL-cholesterol and secondarily, on other biological risk indicators and on changes in lifestyle and psychological lifestyle determinants. Emphasis will also be paid to the cost-effectiveness, to factors that modify the effectiveness of the intervention, and to increasing the potential for public health impact. The experience of the combined personalised and household approach in a high-risk group can be transferred to other groups in which the presence of a high risk situation is clustered, such as Familial Combined Hyperlipidaemia, and the metabolic syndrome.

Onderwerpen

Kenmerken

Projectnummer:
120610016
Looptijd: 100%
Looptijd: 100 %
2007
2011
Onderdeel van programma:
Projectleider en penvoerder:
Dr. L.L.J. Koppes
Verantwoordelijke organisatie:
Amsterdam UMC - locatie VUmc