Primary objective: The primary purpose of the study is to investigate the effect of the Heart Coach program (in addition to usual care) on the individual risk factors body mass index, waist circumference, blood pressure, cholesterol, physical…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-BMI
-waist size
-Physical activity
-Food intake
- Blood Pressure
-Cholesterol (total, HDL and LDL)
.
Secondary outcome
Secundary outcomes
- Bloodglucose
- HbA1c
- Smoking
- Medication adherence
.
Background summary
Patients who have coronary heart disease lead a high probability of future
clinical events. To prevent this, it is important that patients are aware of
the risk factors for cardiovascular event and of the potential for better
control through adapting their lifestyle. However, current treatments are not
sufficiently successful in facilitating a lifestyle change so that the risk of
coronary heart disease decreases. Therefore, there is a need for effective
lifestyle management interventions. A program that stimulates peoples*
self-awareness of their personal risk factors and values they should pursue is:
Coaching Patients On Achieving Cardiovascular Health (Heartcoach). In this
program, a trained professional coaches patients achieving targets of the
influential risk factors, while focusing on lifestyle factors and drug use. In
Australia good results have been achieved with Heartcoach. Heartcoach is also
expected to have a beneficial effect on the health of patients with coronary
artery disease in the Netherlands.
.
Study objective
Primary objective: The primary purpose of the study is to investigate the
effect of the Heart Coach program (in addition to usual care) on the individual
risk factors body mass index, waist circumference, blood pressure, cholesterol,
physical activity and diet in patients with a coronary event (ACS or stable
angina which PCI and / or CABG).
Secondary goal: Secondary purpose of this study is to see to what extent the
Heart Coach program, compared to usual care, affects glucose, HbA1c, smoking,
compliance, self-management, anxiety, depression and quality of life.
The effect of the Heart Coach program on the cardiovascular risk profile of the
patient is also evaluated using two risk scores, calculated from several
individual risk factors. For this, the SCORE (gender, age, smoking,
cholesterol, (systolic) blood pressure, Conroy et al, 2003) and the Framingham
coronary risk score (age, smoking, cholesterol, (systolic) blood pressure,
treatment for hypertension, and diabetes status; D'Agostino et al, 2008) is
used.
Study design
A randomized controlled clinical trial. The experimental group (Heartcoach +
usual care) is compared with a control group (delayed heartcoach + usual care).
In total, 400 patients with coronary disease are included, 200 in each group.
These patients are recruited through the participating hospitals. During the
study, we will try to find additional funding for a measurement at 12 months.
This will provide a follow-up measurement and will change the study design into
a cross-over design.
Intervention
The experimental group receives the Heartcoach program in addition to usual
care (that is: care that all patients with coronary artery disease receive from
the hospital, doctor, physiotherapist etc. and possibly a rehabilitation
phase). The control group recieves usual care.
Study burden and risks
The measurements of height and weight, blood pressure (by sphygmomanometer),
cholesterol and blood glucose (by taking blood) are performed once at week 0
and once after 6 monthsin the treating hospital . For physical activity,
smoking, diet, disease perception, self-management, quality of life, depression
and adherence a questionnaire completed by the participants in the same week .
In principle, patients fill in these questionnaire themselves, but if
necessary, the research assistant can help the participants to fill in the
questionnaires by telephone. Participation in research takes time from
patients, but little additional effort or discomfort.
.
.
Schipholweg 81
Leiden 2316 ZL
NL
Schipholweg 81
Leiden 2316 ZL
NL
Listed location countries
Age
Inclusion criteria
1. The patient was admitted to one of the participating hospitals because of an acute coronary syndrome (STEMI, NSTEMI, IAP) or stable angina pectoris. The patients were treated with a corinary artery bypass (CABG), percutaneous coronary intervention (PCI) or with medication.
Exclusion criteria
1. have no telephone
2. do not speak the Dutch language
3. are, according to their doctors to ill to participate in the programme ((NYHA 3 or 4, prognosis of death < 2 year)
4. participate in another, comparable programme
5. refuse to sign the informed consent
6. are incapable to attend the 6 months measurement
Design
Recruitment
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 | NL32896.018.11 |