Clinical trial NCT03260582: Implementation and Assessment of a Life-style Focused Patient Support Application in Myocardial Infarction Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: cardiac rehabilitation
eHealth
smartphone application
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in submaximal exercise capacity in watts (W)
timeFrame: Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits
Secondary outcomes:
measure: Change in self-reported health
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in healthy diet index
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Smoking habits
timeFrame: First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in weight
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in BMI
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in waist circumference
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in systolic blood pressure
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in diastolic blood pressure
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in total cholesterol
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in LDL cholesterol
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in HDL cholesterol
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in triglycerides
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in fasting plasma glucose
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Change in hemoglobin A1c
timeFrame: Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI
measure: Changes in self-reported physical activity
timeFrame: Change between baseline, first (2-4 weeks post-MI) and second (4-6 months post-MI) physiotherapist visits post-MI
measure: Uptake
timeFrame: Six months
measure: Adherence
timeFrame: Six months
measure: Number of contacts with the CR staff
timeFrame: 12-14 months
measure: Incident cardiovascular events at one year
timeFrame: One year
measure: Incident cardiovascular events at three years
timeFrame: Three years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Dept of Cardiology, Skane University Hospital
city: Malmo
country: Sweden
facility: Dept of Cardiology, Skane University Hospital
city: Umeå
country: Sweden
facility: Dept of Cardiology
Study officials:
affiliation: Skane University Hospital and Lund University, Malmo, Sweden
name: Margret Leosdottir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.