Acute Myocardial Infarction (AMI), Cardiac Rehabilitation
Conditions
Brief summary
The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors
Detailed description
The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; Adherence to cardiac rehabilitation program; Adherence to pharmacological treatment; Quality of Life improvement ; Anxiety and depression; Satisfaction rate; Functional capacity; Cardiac cause hospitalization; Emergency visits; and Angioplasty revascularization procedure.
Interventions
BEHAVIORALExperimental: Cardiac tele-rehabilitation
Patients will connect to their health care provider via a tele-call
BEHAVIORALOther: Control, in person cardiac rehabilitation
Patients will attend an ambulatory cardiac rehabilitation unit
Sponsors
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarct prior to 2 months * Killip I-II classification * No previous myocardial infarction * No angina pectoris * No ischemia in complementary explorations * Normal arterial pressure response during stress test. * No relevant arrythmias * Left ventricular ejection fraction \>= 35% * Functional capacity \>5 METS * Signing of the inform consent
Exclusion criteria
* Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program * Impossibility for digital media use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits | • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days] | Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits 1. Blood pressure \<140/90 mmHg 2. Maintaining normal weight or a 5% reduction in body weight if BMI \> 25 kg/m2 3. Abdominal circumference \<88 cm in women and \<102 cm in men 4. LDL \<50 mg/dl and a reduction of \>50% in initial LDL levels 5. Smoking cessation 6. Adherence to a heart-healthy diet (PREDIMED Questionnaire\* ≥7) 7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ\*\* result (International Physical Activity Questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to cardiac rehabilitation program | 2 months +-30 day | % of patients adherent to cardiac rehabilitation program |
| Adherence to pharmacological treatment | 0-2months +- 30 days-6 months +-7days | Adherence to pharmacological treatment by Morinsky Green Questionnaire, Dichotomous variable: yes means adherent to treatment wich is a better score and no means non adherent to treatment wich is a worse score. |
| Quality of Life improvement | 0-2months +- 30 days-6 months +-7days | Quality of Life by EuroQol-5D questionnaire. EuroQoL-5D index (0-1) 0: Represent the worse state of Health, equivalent to death. 1: Represents the best state of Health ( no problems in any dimension of the questionnaire). |
| Anxiety and depression | 0-2months +- 30 days-6 months +-7days | Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire: 0-42: Higher values are worse than lower values. |
| Functional capacity | 0-2months +- 30 days | Functional capacity by cardiac stress test (METS) |
| Cardiac cause hospitalization | 6 months +-7days | Cardiac cause hospitalization |
| Emergency visits | 6 months +-7days | Emergency visits |
| Angioplasty revascularization procedure | 0-2months +- 30 days | Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better |
| Satisfaction rate | 2months +- 30 days | Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost analysis | 6 months +-7days | Analyze in terms of economic cost (euros) whether there are differences between both programs ( total cost of Telerehabilitation program and total cost of in person program) Total cost includes: direct costs, indirect costs, and intangible costs. |
Countries
Spain
Outcome results
None listed