Primary objective of the OPTICARE study is to evaluate whether patients with acute coronary syndrome (ACS) will derive additional benefit from an extended CR program compared to standard CR.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in cardiac risk factors, higher physical activity and better quality
of life in the intervention group.
Secondary outcome
Earlier return-to-work, less health care consumption, less anxiety and
depression in the intervention group.
Background summary
Throughout the western world, healthy life style management is becoming
increasingly important as the incidence of obesity,
hypertension, and diabetes is rising, taking on epidemic proportions. According
to the World Health Organisation 75 % of
cardiovascular diseases could be prevented by optimal life style management.
Since the introduction of primary angioplasty
(primary PCI) more patients not only survive an acute myocardial infarction
(AMI) but also have a better preserved cardiac
function. Hence, the number of patients requiring long time medical care is
growing, leading to a concomitant burden on the
health care system. Therefore, secondary prevention with an emphasis on
lifestyle adjustments should be the cornerstone of
modern cardiac rehabilitation (CR). Guidelines for healthy life style
management as part of CR are based on results of previous
studies. According to these guidelines important goals of CR are smoking
cessation, improved dietary and stress management
and increased daily activity levels. However, there is a considerable gap
between these guidelines and their actual
implementation. This gap could be the cause of the poor adherence to lifestyle
modifications often seen after completion of
standard CR. The life style modifications are often not incorporated into daily
routine. This study may demonstrate the benefits
of extended CR with respect to achieving optimal long term secondary prevention
goals. Implementation of this extended CR
should result in a cost-effective program. If the hypothesis of the proposed
study is confirmed, relative small adjustments to the
current CR program may enhance secondary prevention in patients after an acute
coronary event, improve their quality of life
and reduce health care consumption
Study objective
Primary objective of the OPTICARE study is to evaluate whether patients with
acute coronary syndrome (ACS) will derive additional benefit from an extended
CR program compared to standard CR.
Study design
A sample size of 500 patients in the three treatment arms is needed to detect a
difference of 20% in the main outcome
measures based on a two-sided alpha and a power of 80%.
Patients will be randomized into 2 arms:
1) Control arm: standard CR according to the guidelines: (a) consisting of 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). There is also the possibility for individually based psychological
programs during these 12 weeks.
2) First treatment arm: extended CR: (a) standard CR consisting of 2 times a
week exercise program of 1.5 hours during 12 weeks.
(b) 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.
3) Second treatment arm: COACH intervention arm: 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
Intervention
Extended cardiac rehabilitation
Study burden and risks
none
's-Gravendijkwal 230
Rotterdam 3012 CE
NL
's-Gravendijkwal 230
Rotterdam 3012 CE
NL
Listed location countries
Age
Inclusion criteria
Patients who are referred after an acute coronary syndrome for cardiac rehabilitation.
Be able to complete the Dutch language questionnaires.
Able to attend regularly the supervised exercise program.
Exclusion criteria
Hart failure, heart valve disease, congenital disease, psychic or cognitive impairment, severe arrhythmias
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 |
|---|---|
| ClinicalTrials.gov | NCT01395095 |
| CCMO | NL34278.078.10 |