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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: LifePod®

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 222 41
    • Dept of Cardiology, Skåne University Hospital
  • Malmo, Sweden, 20502
    • Dept of Cardiology, Skåne University Hospital
  • Umeå, Sweden, 907 46
    • Dept of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm (n=50); Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction.
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Margret Leosdottir, MD, PhD, Skane University Hospital and Lund University, Malmo, Sweden

Publications and helpful links

General Publications

• Ogmundsdottir Michelsen H, Sjolin I, Back M, Gonzalez Garcia M, Olsson A, Sandberg C, Schiopu A, Leosdottir M. Effect of a Lifestyle-Focused Web-Based Application on Risk Factor Management in Patients Who Have Had a Myocardial Infarction: Randomized Controlled Trial. J Med Internet Res. 2022 Mar 31;24(3):e25224. doi: 10.2196/25224.
• Gonzalez M, Sjolin I, Back M, Ogmundsdottir Michelsen H, Tanha T, Sandberg C, Schiopu A, Leosdottir M. Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial. Trials. 2019 Jan 24;20(1):76. doi: 10.1186/s13063-018-3118-1.

Helpful Links

• Cross Technology Solutions home page

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: eHealth; smartphone application; cardiac rehabilitation
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No