Clinical trial NCT04294940: Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
Official title: Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: CardiCare
Coronary heart disease
Application
Mobile
Acute coronary syndrome
Lead sponsor: Ad scientiam
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost.

After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting.

Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle.

A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement.

Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max.

The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR.

The mobile application CardiCare™ consists of several modules:

* A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm
* Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life
* Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit
* Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years old.
* Diagnosis of an Acute Coronary Syndrome in the last 3 months, documented by angiographically-proven coronary artery disease or hospitalisation report.
* Graduated from a phase 2 cardiac rehabilitation, ready to enter a phase 3 CR at home.
* Having agreed to perform a cardiopulmonary exercise testing and blood count at the inclusion or having performed a cardiopulmonary exercise testing and blood count within the last week.
* Owning a personal smartphone (Android 5.0 or beyond / iPhone 5s and newer supporting IOS 12 and beyond) with Wifi or a data plan (3G/4G).
* Able to use a smartphone (e.g. no vision, hearing, cognitive or dexterity impairment).
* Having agreed to install CardiCare™ application on their own smartphone.
* Having agreed to wear an actigraph at all times and install the actigraph application (CenterPoint Sync) on their smartphone.
* Enrolled in or benefiting of a national health system.
* Having read the information sheet and signed the informed consent form.

Non-inclusion Criteria:

* Treated with Coronary Artery Bypass Grafting.
* Cardiac surgery in the last 12 weeks.
* Planned revascularisation or surgery in the next 6 months.
* Clinical heart failure or Left Ventricular Ejection Fraction \< 40% documented within the last 2 months.
* Severe valvular disease.
* Severe pulmonary disease.
* Chronic kidney disease (stages III-V).
* Drug or/and alcohol abuse (as per clinician's judgment).
* Unstable angina.
* Osteoarticular condition or other reasons that limit exercise for more than 4 months (clinician's judgment).
* Uncontrolled hypertension (resting Diastolic BP\>100 mmHg and resting Systolic BP \>200 mmHg).
* Severe/uncontrolled arrhythmia.
* Systemic medical diseases that are likely to affect cognitive functioning.
* Pregnant women confirmed by a pregnancy test at the inclusion.
* Participation to another interventional clinical trial (category 1).
* Illiterate or not proficient in the language of the study country (French, Italian, Spanish or Portuguese according to the country).
* Person under guardianship or curatorship.

Primary outcomes:
measure: To evaluate the efficacy at 6 months of CardiCare™ in stabilising or improving the Cardiorespiratory Fitness of patients after acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program, versus standard care.
timeFrame: From day 0 to month 6
Secondary outcomes:
measure: To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up.
timeFrame: From day 0 to month 6
measure: To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups.
timeFrame: From day 0 to month 3
measure: To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate medication compliance in both groups.
timeFrame: From day 0 to month 6
measure: To compare differences of reported cardiovascular events at 3 and 6 months, in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors.
timeFrame: From day 0 to month 3 and month 6
measure: To assess the cost-effectiveness to reduce 30-day, 3 months and 6 months readmission rates using CardiCare™ as an intervention compared to standard care.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on exercise performed in group B.
timeFrame: From day 0 to month 6
measure: To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups.
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B.
timeFrame: From day 0 to month 6
measure: To identify patterns of VO2max evolution between D0, M3 and M6, between both groups
timeFrame: From day 0 to month 3 and month 6
measure: To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up.
timeFrame: From day 0 to month 6
measure: To evaluate the safety of the CardiCare™ use.
timeFrame: From day 0 to month 6
measure: To collect patients and investigators feedback on the CardiCare™ application.
timeFrame: From day 0 to month 6
Other outcomes:
Locations:
city: Issy les Moulineaux
country: France
facility: Corentin Celton hospital
city: Paris
country: France
facility: Lariboisière hospital
city: Rennes
country: France
facility: Saint-Yves clinic
city: Villeneuve-Saint-Denis
country: France
facility: Brie Cardiac Readaptation Centre
city: Pavia
country: Italy
facility: Maugeri Scientific Clinical Institutes
city: Roma
country: Italy
facility: Scientific Institute of Hospitalization and Care San Raffaele Pisana
city: Carnaxide
country: Portugal
facility: CHOL - Santa Cruz hospital
city: Lisboa
country: Portugal
facility: CHULN - Santa Marta hospital
city: Madrid
country: Spain
facility: Carlos III - La Paz Hospital
city: Santiago De Compostela
country: Spain
facility: Santiago University Hospital
Study officials:
affiliation: Lariboisière Hospital
name: Alain Cohen Solal, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.