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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.

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: RESPONSE 2 Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 RESPONSE 2: Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20582
Enrollment
1000
Registered
2013-04-08
Start date
2013-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary intervention, nurse coordinated care, acute coronary syndrome Secondaire interventie, verpleegkundig gecoördineerd spreekuur, acuut coronair syndroom

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
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

Sponsors

Department of cardiology
Lead Sponsor

Eligibility

Inclusion criteria

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) 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:"

Exclusion criteria

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.

Design outcomes

Secondary

MeasureTime frame
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). 8. Heart Rate Recovery after the 6 Minute Walk test

Primary

MeasureTime frame
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.

Contacts

Public ContactSangeeta Lachman

Department of Cardiology, F3-241, AMC P.O Box 22660

s.lachman@amc.uva.nl+31 (0)20 5661720

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)