|- candidate number||8166|
|- NTR Number||NTR2388|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jun-2010|
|- Secondary IDs||B264 Achmea Zorg|
|- Public Title||Evaluation Program “Coaching patients On Achieving Cardiovascular Health” (COACH).|
|- Scientific Title||Evaluation Program “Coaching patients On Achieving Cardiovascular Health” (COACH).|
|- hypothesis||Participation in the COACH program has positive effects on the health of patients with coronary heart disease.|
|- Healt Condition(s) or Problem(s) studied||Coronary artery disease|
|- Inclusion criteria||1. The patient was admitted to one of the participating hospitals because of coronary heart disease (acute myocardial infarction or chronical/instable angina). The patients were treated with a corinary artery bypass, percutaneous coronary intervention'or with medication;|
2. The patient has finished the hospitals rehabilitation programme.
|- Exclusion criteria||1. Have no telephone;|
2. Do not speak the Dutch language;
3. Are, according to their doctos to ill to participate in the programme;
4. Participate in another, comparable programme.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-jun-2012|
|- Target number of participants||400|
|- Interventions||Coaching Patients On Achieving Cardiovascular Health (COACH) is a program that stimulates peoples’ self-awareness of their personal risk factors and values they should pursue. In this program, a trained professional coaches patients achieving targets of the influential risk factors, while focusing on lifestyle factors and drug use.
The intervention in the experimental COACH-group consists of providing a COACH program in addition to the usual care that patients normally receive during this period from the hospital, general practitioner, physiotherapist etc. The COACH program consists of an intensive period of six months, followed by a maintenance phase. This study focuses on the effects of the intensive phase. In the intensive phase, coaches approach patients to participate in the program and ensure that the start values for risk factors and medication use are known. Within two weeks after inclusion, the patient is contacted by the coach by telephone for the first session. During the COACH-programme, the patients is contacted at least once every six weeks by the coach. Each session contains the next cycle (Vale et al 2002a):
1. Education - 1: The patient is asked what he/she knows about the risk factors, treatment and goals of treatment. About cholesterol, for example, it is asked whether the patient knows its own values, knows the risks for high cholesterol and knows what his / her targets are;
2. Education - 2: The patient is informed about those risk factors that are not yet fully known or understood by the patient;
3. Assertiveness training / empowerment: The patient is stimulated to request his/her doctor information about his / her health and treatment. Examples of questions that a patient may ask are: what cholesterol levels do I have? How appropriate is the prescribed medication? Is the prescribed dosage (still) true? Is there another drug with less side effects?
4. Setting goals / action plan: The coach is negotiating with the patient on an action plan containing targets to be accomplished at the next coaching session;
5. Monitoring during the next coaching session: It is checked whether the patient has taken actions as agreed during the previous session. This information is then used as the basis for the next session which implies the same cycle (steps 1 through 4).
The control-group receives the usual care that patients with coronary heart disease normally receive from the hospital, general practitioner, physiotherapist etc.
|- Primary outcome||1. BMI;|
2. Physical activity;
3. Blood Pressure;
4. Cholesterol (total, HDL and LDL).
|- Secondary outcome||1. Glucose;|
2. Food intake;
4. Health Perception;
5. Quality of life in heart failure;
6. Adherence (medication);
|- Timepoints||All outcomes will be measured twice: Once in week 0 (start of COACH-programme) and at week 26 (after the Coach-programme).
BMI will be measured with a balance and a tape measure, blood pressure with a sphygmometer, cholesterol and glucose by bloodsamples. Alle other variables are measured through written questionnaires:
1. Physical activity: SQUASH (Short Questionnaire to Assess Health Enhancing Physical Activity);
2. Depression: CAD (cardiac depression score);
3. Adherence to medication: MARS (Medication Adherence Rating Scale);
4. Health perception: IPQ-R (The revised illness perception questionnaire);
5. Food intake (Voedingsvragenlijst Universiteit Maastricht, van Assema);
6. Quality of life: SF-12.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Chantal Leemrijse|
|- CONTACT for SCIENTIFIC QUERIES|| Chantal Leemrijse|
|- Sponsor/Initiator ||Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL)|
(Source(s) of Monetary or Material Support)
|- Brief summary||After treatment of cardiovascular disease, patients continue to face physical limitations. Of the people who have had a heart attack, about 15% experiences a second one. To avoid these relapses is it is important that patients are aware of the risk factors for cardiovascular disease 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 (COACH). 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 the programme. The purpose of the present study is to evaluate the impact of the COACH program on the health of patients with coronary heart disease evaluation in the Netherlands. |
The study design is a randomized controlled clinical trial. Participants are patients that have been treated with bypass surgery, angioplasty or medication for an acute myocardial infarction or chronic or unstable angina. The experimental group (n=200) receives the COACH program during 6 months in addition to usual care (that is: care that all patients with coronary artery disease receive from the hospital, doctor, physiotherapist etc. after they have completed the rehabilitation phase). The control group (n=200) receives usual care. Patients are recruited through the participating hospitals. We will look at the impact of the COACH program at the Body Mass Index (BMI), physical activity, cholesterol and blood pressure (primary outcome measures) and at the impact on a number of other risk factors for cardiovascular disease such as glucose concentration, smoking and medication intake (secondary outcomes).
|- Main changes (audit trail)|
|- RECORD||21-jun-2010 - 7-jul-2010|