|- candidate number||14680|
|- NTR Number||NTR3937|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-apr-2013|
|- Secondary IDs||2012_272 / NL41645.018.12; METC / CCMO|
|- Public Title||Effects of a nurse coordinated program of lifestyle interventions aimed at reducing the risk of recurrent events in patients who have suffered a heart attack. |
|- Scientific Title||Effects of a nurse coordinated program of lifestyle interventions aimed at reducing the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome:
Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2
Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2.
|- ACRONYM||RESPONSE 2|
|- hypothesis||A comprehensive multisiciplinary lifestyle intervention program reduces the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome.|
|- Healt Condition(s) or Problem(s) studied||Acute coronary syndrome (ACS), Nurse coordinated care, Secundary prevention, Coronary artery disease|
|- Inclusion criteria||Patients aged 18-80 years who have been hospitalized for an acute coronary syndrome less than 4 weeks before inclusion and who have at least one of the following lifestyle related risk factors:|
1. Smoking (including smoking of any tobacco product in the 6 months preceding hospitalisation);
2. BMI≥27 kg/m2;
3. Physical activity below recommended levels (self reported, 5 times 30 minutes/week)
|- Exclusion criteria||Patients are ineligible if they meet any of the following exclusion criteria:|
1. Visits to the prevention programs not feasible;
2. Not available for follow-up;
3. Coronary arterial bypass graft surgery expected within 8 weeks after inclusion;
4. Limited life expectancy (≤2 years);
5. New York Heart Association class III or IV heart failure;
6. Patients with a HADS (Hospital Anxiety Depression Scale) score ≥ 14 will also be excluded from randomisation, but they will be included in a separate registry and invited for follow-up measurements after 12 months.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2013|
|- planned closingdate||1-aug-2016|
|- Target number of participants||1000|
|- Interventions||On top of usual care, the intervention group will receive a comprehensive, modular, tailored lifestyle intervention, involving the partner where appropriate, using e-health support and referral to up to three existing commercial programs for weight reduction (Weight Watchers®), physical exercise (DirectLife®, Philips) and smoking cessation (Luchtsignaal®).
Each intervention program lasts at least 3 months.
Weight Watchers and DirectLife can be offered for a longer period than 3 months if necessary.
Weight Watchers offers a program aimed at reducing weight and at improving awareness of healthy foods.
DirectLife offers a commercial activity program, to improve more awareness of the daily physical activity. This program consists of an accelerometer and a personal coach in a web based system.
Luchtsignaal offers personal telephone based coaching during 3 months, including drug intervention where appropriate.
The control group will receive care as usual; patients randomized in this group will not be offered a commercial program in order to improve their lifestyle. As per current guidelines, they will be advised by their nurse (practitioner) to improve their lifestyle. If necessary, patients may be referred to existing smoking cessation programs.
|- Primary outcome||The following parameters are compared between the intervention group and the control group at 12 months: |
1. Smoking status (binary, non-smoking is defined as urinary cotinine < 200 ng/ml);
2. Body Mass Index (kg/m2);
3. 6 Minute walking distance (meters).
Treatment success in an individual patient is defined as a significant improvement in at least one of the suboptimal lifestyle factors, without deterioration in any of the other two.
|- Secondary outcome||Comparison between baseline and 12 months of:|
1. Smoking status (urinary cotinine < 200 ng /ml);
2. Body Mass Index (kg/m2);
3. Waist circumference (cm);
4. 6 Minute walking distance (meters).
The following parameters are compared between the intervention group and the control group at 12 months:
1. Fasting serum LDL level (mmol /l);
2. Systolic blood pressure (mmHg);
3. Incidence of newly diagnosed diabetes mellitus;
4. Control of existing diabetes mellitus (fasting blood glucose and plasma HbA1c levels);
5. Body composition (fat and muscle mass by impedance scales);
6. Hospital readmission rates;
7. Signs of depression (Hospital Anxiety and Depression score).
|- Timepoints||After 12 months each patient will be invited for 12 month follow-up.
In this research there will be specific visits for measurements:
Five nurse led visits will be offered, including the baseline visit and the 12 months follow-up visit. During each visit the cardiovascular risk profile will be evaluated including of lifestyle related risk factors.
During a year patients in the intervention group have the opportunity to attend the offered commercial programs in order to improve their lifestyles, with their partner where appropriate.
Full study measurements will be performed at baseline and at 12 months follow-up.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, Research Fellow Sangeeta Lachman|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD, R.J.G. Peters|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Cardiology|
(Source(s) of Monetary or Material Support)
|Philips, Weight Watchers, Philips Consumer Lifestyle Nederland|
|- Brief summary||A previous trial, RESPONSE 1, demonstrated that a practice oriented, hospital-based nurse coordinated prevention program on top of usual care leads to an important reduction in the risk of recurrent events in patients who have been hospitalised for an acute coronary syndrome. This improvement was achieved by better control of targets for drug treatment, including blood pressure and serum lipids. Lifestyle improvements were not achieved, however particularly regarding smoking cessation, physical exercise or weight loss.|
The RESPONSE 2 trial will focus on lifestyle improvements by offering existing commercial programs regarding the lifestyles mentioned above. The study design consists of a multicenter randomised controlled trial, in at least 10 participating centres in the Netherlands
The primary outcome of RESPONSE 2 is the achievement of successful management of lifestyle related risk factors in the intervention group compared to the control group after 12 months follow-up.
|- Main changes (audit trail)||'Patients aged 18-80 years who have been ….. less than 8 weeks (instead of 4) before inclusion and who have at least one of the following lifestyle related risk factors'|
Added the folowing sentence to interventions: Patients with a HADS > 14 will be included in a separate registry.They will not participate in the randomization and their results will not contribute to the primary outcome of the study.
Timepoints: Up to six, instead of five, nurse led visits will be offered, including the baseline visit and the 12 months follow-up visit.
The study design consists of a multicenter randomised controlled trial, in 1000 patients in approximately 10-15 participating centres in the Netherlands
10-jul-2014: Inclusion criterium changed into: "Patients aged 18years and older who have been hospitalized for an acute coronary syndrome or patients who have recently undergone coronary artery bypass surgery or a percutaneous coronary intervention less than 8 (instead of 4) weeks before inclusion and who have at least one of the following lifestyle related risk factors:"
Additional of secondary outcome:
8. Heart Rate Recovery after the 6 Minute Walk test - AB
5-nov-2014: "The following lifestyle-related CAD risk factor combinations are possible at the individual level at baseline:
1. Smoking only
2. BMI ≥ 27 kg/m2 only
3. Physical inactivity only
4. Smoking and BMI ≥ 27 kg/m2
5. Smoking and physical inactivity
6. BMI ≥ 27 kg/m2 and physical inactivity
7. Smoking, BMI ≥ 27 kg/m2 and physical inactivity
At 12 month follow-up treatment success is defined as achieving the target for at least one of the three
lifestyle-related risk factors, without deterioration in any of the other. Note that if smoking cessation is
accomplished, an increase of ≤ 2.5% in the BMI or BMI remaining < 25 kg/m2 will be classified as no
An increase of ≤ 2.5% in the BMI or BMI remaining < 25 kg/m2 in case of significantly improved level
for physical activity is also classified as no deterioration, because of the possibility that exercise may
increase muscle mass." - AB
|- RECORD||8-apr-2013 - 24-jun-2015|