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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lund University
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Change in submaximal exercise capacity in watts (W)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control arm (n=50)
Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction.
Intervention arm: LifePod arm (n=100)
In addition to usual cardiac rehabilitation care, patients randomized to the LifePod arm will receive access to the LifePod® support software for six months.
Intervention: LifePod® (Other)
Outcomes
Primary Outcomes
Change in submaximal exercise capacity in watts (W)
Time Frame: Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits
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.
Secondary Outcomes
- Change in BMI(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in waist circumference(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(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(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in 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(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in HDL cholesterol(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in self-reported health(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(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Smoking habits(First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in weight(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in triglycerides(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(Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI)
- Change in hemoglobin A1c(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(Change between baseline, first (2-4 weeks post-MI) and second (4-6 months post-MI) physiotherapist visits post-MI)
- Uptake(Six months)
- Adherence(Six months)
- Number of contacts with the CR staff(12-14 months)
- Incident cardiovascular events at one year(One year)
- Incident cardiovascular events at three years(Three years)