Myocardial InfarctionNCT03260582
Implementation and Assessment of a Life-style Focused Patient Support Application in Myocardial Infarction Patients
A study testing LifePod® in people with Myocardial Infarction, run by Lund University at 3 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- LifePod®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesSweden
- Study dates
- Apr 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Dept of Cardiology, Skane University Hospital
Lund, 222 41
Dept of Cardiology, Skane University Hospital
Malmö, 20502
Dept of Cardiology
Umeå, 907 46
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- LifePod®
- Keywords
- cardiac rehabilitation, eHealth, smartphone application
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePod®Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm (n=50) | No intervention | Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction. |
| Intervention arm: LifePod arm (n=100) | Experimental | In addition to usual cardiac rehabilitation care, patients randomized to the LifePod arm will receive access to the LifePod® support software for six months. Receives: Other: LifePod® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits
Secondary outcomes (20)
Change in self-reported health
Self-reported Health is measured using the Visual Analogue Scale (0-100)
Measured: 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
Measured: 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)
Measured: First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
Change in weight
Weight measured in kg
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Six months
Adherence
The proportion of patients registering data at least twice per week on a weekly basis throughout the intervention period
Measured: Six months
Number of contacts with the CR staff
Number of telephone and physical contacts with the CR staff during the follow-up period
Measured: 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
Measured: 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
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startApr 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margret Leosdottir, MD, PhD, Principal investigator, Skane University Hospital and Lund University, Malmo, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260582
- Status last verified
- Oct 2019
- First submitted
- 14 Jun 2017
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35357316Gonzalez 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.
PubMed 30678709
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03260582
- Conditions
- Myocardial Infarction
- Keywords
- cardiac rehabilitation, eHealth, smartphone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm (n=50) | No intervention | –Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction. |
| Intervention arm: LifePod arm (n=100) | Experimental | Other: LifePod®In addition to usual cardiac rehabilitation care, patients randomized to the LifePod arm will receive access to the LifePod® support software for six months. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention arm: LifePod arm (n=100) |
Primary outcome
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.
20 secondary outcomes
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
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
Smoking habits
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
Uptake
Time frame: Six months
Adherence
Time frame: Six months
Number of contacts with the CR staff
Time frame: 12-14 months
Incident cardiovascular events at one year
Time frame: One year
Incident cardiovascular events at three years
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 35357316Ogmundsdottir 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.
- Derived from this study: PubMed 30678709Gonzalez 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.
- Cross Technology Solutions home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margret Leosdottir, MD, PhD principal investigator
Skane University Hospital and Lund University, Malmo, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifePod® in people with Myocardial Infarction, run by Lund University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.