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Trial record 1 of 1 for:    NCT03260582 | Sweden
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Implementation and Assessment of a Life-style Focused Patient Support Application in Myocardial Infarction Patients

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ClinicalTrials.gov Identifier: NCT03260582
Recruitment Status : Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: LifePod® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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

  15. 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

  16. Uptake [ Time Frame: Six months ]
    The proportion of patients who log on to the patient interface at least once

  17. Adherence [ Time Frame: Six months ]
    The proportion of patients registering data at least twice per week on a weekly basis throughout the intervention period

  18. 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

  19. 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

  20. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260582


Locations
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Sweden
Dept of Cardiology, Skane University Hospital
Lund, Sweden, 222 41
Dept of Cardiology, Skane University Hospital
Malmo, Sweden, 20502
Dept of Cardiology
Umeå, Sweden, 907 46
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Margret Leosdottir, MD, PhD Skane University Hospital and Lund University, Malmo, Sweden

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03260582     History of Changes
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:
cardiac rehabilitation
eHealth
smartphone application

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases