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

October 24, 2019 updated by: Lund University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in self-reported health
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
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
Time Frame: Change between baseline, first (2-4 weeks post-MI) and second (4-6 months post-MI) physiotherapist visits post-MI
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
Time Frame: Six months
The proportion of patients who log on to the patient interface at least once
Six months
Adherence
Time Frame: Six months
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
Time Frame: 12-14 months
Number of telephone and physical contacts with the CR staff during the follow-up period
12-14 months
Incident cardiovascular events at one year
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lund University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margret Leosdottir, MD, PhD, Skane University Hospital and Lund University, Malmo, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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