Clinical trial NCT05385341: Rehabilitation Exercise with MObile Technology and Education After Acute Coronary Syndrome
Official title: Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Cardiac rehabilitation
Tele-health
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.

Detailed description: After acute coronary syndrome (ACS), it is recommended to propose a cardiac rehabilitation (CR) program in order to reduce the risk of recidive, to improve the quality of life and to reduce the risk of disabilities. Traditional CR which is most of the time center-based, is underutilized with less than 30% of patients addressed en France. Therefore, Télé-Cardiac Rehabilitation (Télé-RCV) has been developped progressively since the eighties showing comparable efficacity compared with CR concerning physical fitness. The investigative team, had previously published results showing that telephone support guided by accelerometers could improve physical activity. However, In France, device allowing telemonitoring online of heart rate are not available. Moreover, the investigators have not yet developped remote therapeutic education which is proposed in CR programs. Thus, the present study planned to develop and evaluate aTele-RCV solution aimed to monitor exercise training at home and to educate remotely patient after ACS.

The device is an association of a heart rate monitor, a blood pressure testing, a balance linked with a full web secured application connecting patient and caregivers. In the intervention group, Tele-RCV is proposed during 20 sessions containing 2h of exercise training combined with 6h of therapeutic tele-education. In the control group, CR is proposed during 20 sessions with the same volume of exercise training and therapeutic education. After randomisation, patient are allocated to one of the two groups. The evaluation of the primary and secondary outcomes are realized at the beginning, at one month (only walking tests) and at 2 months. A social evaluation is done in parallel to test the acceptability for the Télé-RCV compared with CR.

Eligibility criteria: Inclusion Criteria:

* Patient with acute coronary syndrome less than 6 months,
* Addressed to ambulatory cardiac rehabilitation,
* Equipped with a smartphone compatible with the protocol's application, connected to web
* Having signed an informed consent,
* Affiliated to the french national health insurance.

Exclusion Criteria:

* Incapacity to use application on smartphone,
* Contraindication to exercise training,
* Pregnancy,
* Juridic protection
* Left ventricular ejection fraction \< 45%
* Significate ventricular arrhythmia (frequent or polymorph PVC during initial exercise testing, ventricular tachycardia or sudden cardiac death at the beginning)
* Flutter or atrial fibrillation (transient or permanent)
* Coronary revascularization needing supplementary procedure
* Residual myocardial ischemia determined by initial exercise testing or alternative testing (nuclear imaging or stress echocardiography)
* Mini Mental State \< 26
* Patients living alone at home
* Comorbidities limiting participation to the protocol: kidney dialysis, insulin-requiring diabetes, residuals sequels of central and/or peripheral nervous system injuries

Primary outcomes:
measure: Effect analysis 2 month after inclusion
timeFrame: 2 months
Secondary outcomes:
measure: Effect analysis 1 month after inclusion
timeFrame: 1 month
measure: Effect analysis 1 month after inclusion
timeFrame: 1 month
measure: Effect analysis 2 months after inclusion
timeFrame: 2 months
measure: Effect analysis 2 months after inclusion
timeFrame: 2 months
measure: Health economics criteria
timeFrame: 26 months
measure: Health economics criteria
timeFrame: 26 months
measure: Production cost of the REMOTE-ACS device
timeFrame: 26 months
measure: Acceptability of the device
timeFrame: 26 months
measure: Satisfaction of the device
timeFrame: 26 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Meyer ELBAZ, MD
role: PRINCIPAL_INVESTIGATOR
References: