Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Ad scientiam
- 试验地点
- 10
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Group A: standard of care
The patient will follow the hygiene-dietetic recommendations given by their centre and wear an actigraph night and day.
干预措施: Wear an actigraph (Other)
Group B: standard of care + mobile application CardiCare™
The patient will follow the hygiene-dietetic recommendations given by their centre, wear an actigraph night and day and use the mobile application CardiCare™
干预措施: Use the mobile application CardiCare™ and wear an actigraph (Other)
结局指标
主要结局
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.
时间窗: From day 0 to month 6
Proportion of participants with stabilised or improved VO2max 6 months, as measured by Cardiopulmonary Exercise Test in group B versus group A
次要结局
- To evaluate, for each session, the correlation between self-reported physical activities in CardiCare™ and those collected by the actigraph in group B.(From day 0 to month 6)
- To identify patterns of VO2max evolution between D0, M3 and M6, between both groups(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on sleep quality between groups over time of follow-up.(From day 0 to month 6)
- To evaluate CardiCare™ impact on exercise performed in group B.(From day 0 to month 6)
- To evaluate CardiCare™ impact on change in weight at 3 months and 6 months versus baseline in both groups.(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on global physical activity between both groups over time of follow-up.(From day 0 to month 6)
- To evaluate CardiCare™ impact on change in cardiorespiratory fitness at 3 months versus baseline in both groups.(From day 0 to month 3)
- To evaluate CardiCare™ impact on change in other cardiorespiratory fitness parameters at 3 and 6 months versus baseline, in both groups(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on change in lipid levels at 3 and 6 months versus baseline, in both groups.(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on change in glucose levels at 3 and 6 months versus baseline, in both groups.(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on change in Body Mass Index at 3 months and 6 months versus baseline in both groups.(From day 0 to month 3 and month 6)
- To compare differences of reported cardiovascular events at 3 and 6 months, in both groups.(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on change in Hip and waist circumference at 3 months and 6 months versus baseline in both groups.(From day 0 to month 3 and month 6)
- To evaluate the impact of CardiCare™ on anxiety at 3 and 6 months versus baseline, in both groups.(From day 0 to month 3 and month 6)
- To evaluate the impact of CardiCare™ on quality of life at 3 and 6 months versus baseline, in both groups.(From day 0 to month 3 and month 6)
- To evaluate medication compliance in both groups.(From day 0 to month 6)
- 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.(From day 0 to month 3 and month 6)
- To evaluate CardiCare™ impact on cardiovascular risk factors control at 3 and 6 months versus baseline in both groups.(From day 0 to month 3 and month 6)
- To compare time to first hospital readmission among both groups (all-cause, cardiac, and noncardiac) and their predictors.(From day 0 to month 3 and month 6)
- To evaluate the impact of CardiCare™ on employment status at 3 and 6 months versus baseline in both groups.(From day 0 to month 3 and month 6)
- To collect patients and investigators feedback on the CardiCare™ application.(From day 0 to month 6)
- To evaluate the safety of the CardiCare™ use.(From day 0 to month 6)