OPTImal CArdiac REhabilitation (OPTICARE) Following Acute Coronary Syndromes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Erasmus Medical Center
Sponsor:
Information provided by (Responsible Party):
Ron T van Domburg, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01395095
First received: July 14, 2011
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard cardiac rehabilitation.


Condition Intervention
Risk Factor Reduction
Lifestyle Changes
Other: rehabilitation+telephonic coaching
Other: OPTICARE-B
Other: OPTICARE-C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPTImal CArdiac REhabilitation (OPTICARE)Following Acute Coronary Syndromes: A Randomized, Controlled Trial to Investigate the Benefits of an Expanded Educational and Behavioural Intervention Program.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Reduction of the SCORE Risk Score [ Time Frame: 12 months after the intervention ] [ Designated as safety issue: No ]
    Healthy lifestyle is quantified by the SCORE Risk Score (7). Apart from age, sex, the SCORE includes the modifiable risk factors total cholesterol, HDL cholesterol, systolic blood pressure and smoking status.


Secondary Outcome Measures:
  • improved physical fitness [ Time Frame: 12 months after the intervention ] [ Designated as safety issue: No ]

    increased level of everyday physical activity, reduction of health care consumption in the intervention groups and improved cost-effectiveness in the intervention groups.

    Earlier return to work and improved social participation, improved physical fitness, improved quality of life and less anxiety and depression. On the long-term, patients will be followed up for adverse clinical outcome, defined as mortality and major adverse cardiac events,



Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPTICARE-A
Intervention starts 2 weeks after ending standard cardiac rehabilitation (CR) and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.
Other: rehabilitation+telephonic coaching
intervention starts 2 weeks after ending standard CR and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.
Other Name: cardiac rehabilitation
Active Comparator: OPTICARE-B
Standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions)
Other: OPTICARE-B
standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions).
Other Name: cardiac rehabilitation
Experimental: OPTICARE-C
(a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.
Other: OPTICARE-C
(a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.
Other Name: cardiac rehabilitation

Detailed Description:

Rationale: Throughout the western world, healthy life style management is becoming increasingly important. Therefore, secondary prevention with an emphasis on lifestyle adjustments should be the cornerstone of modern cardiac rehabilitation (CR). This study may demonstrate the benefits of extended CR with respect to achieving optimal long term secondary prevention goals.

Objective: The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions (OPTICARE and COACH) and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard CR.

Study design: The proposed trial is a singlecenter, multi-disciplinary randomized controlled trial with a 24-month follow-up. In total 1200 patients will be randomized into 3 arms:(1) Standard CR according to the Dutch guidelines; (2) OPTICARE intervention: standard CR and participation in multifactorial lifestyle sessions during rehabilitation and additional sessions at 4, 6 and 12 months and a personalized program to promote an active lifestyle; (3) COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone delivered coaching sessions starting at 6 weeks intervals (up to 6 months). The enrollment period will be 24 months, the intervention period is 12 months and the duration of the follow-up will be another 12 months. Assessments will take place at 4 time points: at baseline, 12 weeks after inclusion (end standard CR), at 12 and at 24 months.

Study population: Patients referred for standard CR will be included to participate in this trial. ACS patients treated with primary or elective PCI or CABG, with a stable medical condition and providing written informed consent are eligible to participate.

Intervention: OPTICARE intervention: Standard CR and obligation to participate in multifactorial lifestyle and risk factor sessions (medical information, dietary advises, risk factors and emotional advises). Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counsellor during and after completion of rehabilitation. If applicable, patients will participate in smoking cessation, dietary and stress management programs. Additional supervised multifactorial lifestyle and risk management training sessions of each 2 hours are provided at 4, 6 and 12 months. COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone based coaching sessions starting at 6 weeks intervals up to 6 months. The coaching sessions include assertiveness training, goal setting and reassessment.

Main study parameters/endpoints: The main objective is to investigate whether in patients randomized to extended CR (OPTICARE or COACH) cardiac risk profile will be improved, if these patients maintain healthier life style habits and do achieve an increase in daily activity level compared to patients randomized to standard CR.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an acute coronary syndrome treated with primary or elective PCI or coronary surgery (CABG), with a stable medical condition and providing written informed consent are eligible to participate.
  • Men and women who signed informed consent.
  • Patients are eligible to participate in the study if they are: able to regularly attend a supervised exercise programme and able to complete Dutch language questionnaires.

Exclusion Criteria:

  • Patients with heart failure
  • Impaired left ventricular function (LVEF<40%)
  • Psychic or cognitive impairments
  • Severe arrhythmias
  • Heart valve disease
  • Congenital disease
  • Severe co-morbidities which limit the CR (e.g. severe COPD, severe diabetes or locomotive disorder) and patients with an ICD will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395095

Contacts
Contact: Ron T van Domburg, PhD +31-10-7033933 r.vandomburg@erasmusmc.nl
Contact: Madoka Sunamura, MD +31-10-4366988 sunamurarscr@live.nl

Locations
Netherlands
Capri hartrevalidatie Recruiting
Rotterdam, Netherlands, 3016 BC
Contact: Ron T van Domburg, PhD    +31-10-7033933    r.vandomburg@erasmusmc.nl   
Contact: Madoka Sunamura, MD    +31-10-4366988    sunamurarscr@live.nl   
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Ron T van Domburg, PhD ErasmusMC, Thoraxcenter
Study Director: Felix Zijlstra, MD, PhD ErasmusMC, Thoraxcenter
  More Information

No publications provided

Responsible Party: Ron T van Domburg, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01395095     History of Changes
Other Study ID Numbers: MEC-2010-391
Study First Received: July 14, 2011
Last Updated: March 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
cardiac rehabilitation
risk factor
lifestyle

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014