To quantify the impact of outpatient nurse-led prevention clinics on the risk of future clinical events in patients with symptomatic coronary artery disease.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Glucose metabolism disorders (incl diabetes mellitus)
- Lifestyle issues
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in status of Copenhagen Risk score and modifiable risk factors for
coronary heart disease: smoking, exercise, excess weight, dyslipidaemia,
hypertension, diabetes mellitus compared with group receiving usual care.
Secondary outcome
- Quality of life
- Evaluation of efficiency of reaching treatment targets
- Compliance with medical treatment
- Risk scores: Europa-score, PROCAM-score, Euroscore
Background summary
Treatments in secondary prevention of clinical events in patients with coronary
artery disease are are based on robust evidence but are sub-optimally
implemented in the current 2nd line setting. The modifiable risk factors that
are form the base prevention of cornary artery disease are smoking, lack of
exercise, excess weight, dyslipidaemia, hypertension and diabetes mellitus.
Nurses are potentially better suited for this type of care, and outpatient
nurse-led prevention clinics (NLPC) are being initiated in many centres across
the country and abroad. However, the impact of this new approach remains
largely unknown.
Study objective
To quantify the impact of outpatient nurse-led prevention clinics on the risk
of future clinical events in patients with symptomatic coronary artery disease.
Study design
A randomized clinical trial where patients are randomised into one of two
groups; one intervention group that will be seen by the NLPC, one control group
which will receive usual care in accordance with national guidelines
Intervention
Patients randomised to the intervention group will, in addition to usual care,
be seen at the NLPC. Here they receive counselling and support to promote a
healthy lifestyle, including cessation of smoking, regular exercise, healthy
food choices and weight control. They will receive educational materials to be
studied at home. In subsequent visits, these materials will be discussed. In
addition, patients in the intervention group will be actively screened for
diabetes and hypertension
Intervention group is seen 5 times in 6 months following occurrence of acute
coronary syndrome at a nurse-led outpatient clinic in addition to usual care
(according to national guidelines).
Study burden and risks
No experimental treatments are performed during study.
Main burdens are time investment (controls 3x 30 minutes, interventions 7x 30
minutes) and discomfort inherit in the taking of blood samples (controls 3x
16.2 mL, interventions 7x 16.2 mL). Blood pressure, weight, lenght and
waist-to-hip ratio will be measured during each visit.
Meibergdreef 9 P.O. Box 22660
1100 DD Amsterdam
NL
Meibergdreef 9 P.O. Box 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• Age 18-80 years
• Hospitalisation for an acute coronary syndrome (instabiele angina/acuut hartinfarct) less than 8 weeks before inclusion.
Exclusion criteria
• Clinic visits not feasible
• Not available for follow-up
• Surgery/percutaneous coronary intervention expected within 8 weeks
• Limited life expectancy
• Previously enrolment in nurse-led prevention clinic
• NYHA class 3 or 4 caused by heart failure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11272.018.06 |