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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260582
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2019

Study information

• Verified date: October 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• LifePod®
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.

Locations

Country	Name	City	State
Sweden	Dept of Cardiology, Skane University Hospital	Lund
Sweden	Dept of Cardiology, Skane University Hospital	Malmo
Sweden	Dept of Cardiology	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Uptake	The proportion of patients who log on to the patient interface at least once	Six months
Secondary	Adherence	The proportion of patients registering data at least twice per week on a weekly basis throughout the intervention period	Six months
Secondary	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
Secondary	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
Secondary	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

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