Implementation and Assessment of a Life-style Focused Patient Support Application in Myocardial Infarction Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation and Assessment of a Life-style Focused Patient Support Application (App) and Activity Trackers for Improving Risk Factor Management, Physical Activity, Quality of Life and Prognosis in Post-myocardial Infarction Patients

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: LifePod®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age < 75 years. This cut-off is set as only those < 75 years of age are followed in the national Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry Has suffered an MI within the last 2 weeks Owns a smartphone and/or has access to internet via a computer or surf pad and can handle the software Exclusion criteria Expected survival < 1 year Dementia, severe psychiatric illness or drug abuse Severe physical handicap limiting the patient´s ability to participate in exercise-based CR Not able to speak or understand the Swedish language Three-vessel disease requiring coronary artery bypass grafting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm (n=50)<br>Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction. | |
| Experimental: Intervention arm: LifePod arm (n=100)<br>In addition to usual cardiac rehabilitation care, patients randomized to the LifePod arm will receive access to the LifePod® support software for six months. | Other: LifePod®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported health | Self-reported Health is measured using the Visual Analogue Scale (0-100) | 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 | 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) | First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI | 
| Change in weight | Weight measured in kg | 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 | 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 | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | Six months | 
| Adherence | The proportion of patients registering data at least twice per week on a weekly basis throughout the intervention period | Six months | 
| Number of contacts with the CR staff | Number of telephone and physical contacts with the CR staff during the follow-up period | 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 | 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 | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, eHealth, smartphone application