The study will assess the efficacy of a web-based application as a complement to traditional exercise-based cardiac rehabilitation for improvement of secondary prevention outcomes in post-myocardial infarction patients, compared with usual care. The hypothesis is that the intervention enhances patient adherence to lifestyle advice (exercise training, daily physical activity, healthy diet and tobacco abstinence) and medication, resulting in better risk factor control and prognosis as well as increased self-rated health.
It is well documented that participation in cardiac rehabilitation (CR) programs improves risk factor control and therapy adherence, enhances quality of life and reduces recurrent events. However, the current incomplete fulfilment of guideline recommended CR targets is a matter of concern. Also, while international recommendations advocate program flexibility and individual tailoring, most of the current CR programs are rigid, time-limited and demand substantial health care resources. Therefore, all main international heart associations have claimed for the reengineering of CR to enhance access, adherence, and effectiveness. The general call is for the development of innovative and cost-effective CR programs oriented to modify lifestyle and behaviour with sustainable results and that may be easily integrated in the pre-existing health care structures.eHealth i.e. the use of electronic communication and information technologies in health care, offers a whole new array of possibilities to provide clinical care. These include for example distance monitoring via telecommunication and sensors, interactive computer programs and smart phone applications. While there are thousands of available eHealth applications on the market, only a small minority have been tested in a controlled manner with proper guidance from health care personnel. The study will assess the efficacy of a web-based patient support application as a complement to traditional exercise-based CR for improvement of secondary prevention outcomes in post-MI patients, compared with usual care. The hypothesis is that the intervention enhances patient adherence to lifestyle advice (exercise training, daily physical activity, healthy diet and tobacco abstinence) and medication, resulting in better risk factor control and prognosis as well as increased self-rated health. A secondary hypothesis is that complementing the application with an activity tracker (accelerometer in a smart bracelet) will enhance the effect of the intervention.
Study Type
INTERVENTIONAL
Allocation
The software is a web-based application designed to support persons adhering to lifestyle advice and medication. The patient can log information about lifestyle (i.e. diet, exercise, and smoking), measurements (i.e. weight, pulse and blood pressure), symptoms and medication and can review data in graphs displaying registered values in relation to recommended targets. The software provides positive feedback on healthy choices and gives general recommendations on exercise training, physical activity and healthy diet. Reminders are generated in the case of decreasing registrations. Finally, short text messages (SMS) will be sent out 2-3 times a week with tips on healthy lifestyle.
Dept of Cardiology, Skane University Hospital
Lund, Sweden
Dept of Cardiology, Skane University Hospital
Malmo, Sweden
Dept of Cardiology
Umeå, Sweden
Change in submaximal exercise capacity in watts (W)
Submaximal exercise capacity reflects the patients´ level of physical fitness.The submaximal exercise test is performed on a bicycle ergometer according to the World Health Organisation (WHO) protocol, with an increased workload of 25W every 4.5 minutes The initial starting load, 25W or 50W, is decided, based on the patient's exertion history. After two and four minutes of each workload; heart rate, rate of perceived exertion according to Borg's rating of perceived exertion scale (RPE) and subjective symptoms, including chest pain and dyspnea according to Borg's Category Ratio Scale, CR-10, scale are rated. After three minutes, the systolic blood pressure is registered. The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 on Borg's CR-10 scale.
Time frame: Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits
Change in self-reported health
Self-reported Health is measured using the Visual Analogue Scale (0-100)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in healthy diet index
The healthy diet index is a four-item questionnaire used to evaluate dietary habits within the Swedish Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Smoking habits
Whether the patient is a non-smoker, prior smoker or current smoker (self-report)
Time frame: First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in weight
Weight measured in kg
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RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in BMI
Weight in kilograms (kg) divided by height in meters (m) square
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in waist circumference
Waist circumference measured in cm
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in systolic blood pressure
Systolic blood pressure measured after 5 minutes of rest in supine position (mmHg)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in diastolic blood pressure
Diastolic blood pressure measured after 5 minutes of rest in supine position (mmHg)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in total cholesterol
Fasting plasma total cholesterol
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in LDL cholesterol
Fasting plasma LDL cholesterol (mmol/L)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in HDL cholesterol
Fasting plasma HDL cholesterol (mmol/L)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in triglycerides
Fasting plasma triglycerides (mmol/L)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in fasting plasma glucose
Fasting plasma glucose (mg/dL)
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in hemoglobin A1c
Whole-blood hemoglobin A1c (mmol/mol) by International Federation of Clinical Chemistry (IFCC) standards
Time frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Changes in self-reported physical activity
Self-reported physical activity, as measured by Haskell and Frändin \& Grimby
Time frame: Change between baseline, first (2-4 weeks post-MI) and second (4-6 months post-MI) physiotherapist visits post-MI
Uptake
The proportion of patients who log on to the patient interface at least once
Time frame: Six months
Adherence
The proportion of patients registering data at least twice per week on a weekly basis throughout the intervention period
Time frame: Six months
Number of contacts with the CR staff
Number of telephone and physical contacts with the CR staff during the follow-up period
Time frame: 12-14 months
Incident cardiovascular events at one year
Incidence of cardiovascular events at one year after the index event: hospitalization for a new MI, heart failure or stroke and cardiovascular death
Time frame: One year
Incident cardiovascular events at three years
Incidence of cardiovascular events at three years after the index event: hospitalization for a new MI, heart failure or stroke and cardiovascular death
Time frame: Three years