NCT03260582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

June 14, 2017

Last Update Submit

October 24, 2019

Conditions

Myocardial Infarction

Keywords

cardiac rehabilitationeHealthsmartphone application

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • Change in self-reported health

    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

    Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI

  • Smoking habits

    First (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI

  • Change in weight

    Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI

  • Change in BMI

    Change between baseline, first (6-8 weeks post-MI) and second (12-14 months post-MI) nurse visits post-MI

  • +15 more secondary outcomes

Study Arms (2)

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.

Other: LifePod®

Interventions

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.

Intervention arm: LifePod arm (n=100)

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dept of Cardiology, Skane University Hospital

Lund, 222 41, Sweden

Location

Dept of Cardiology, Skane University Hospital

Malmo, 20502, Sweden

Location

Dept of Cardiology

Umeå, 907 46, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 35357316DERIVED

  • 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.

    PMID: 30678709DERIVED

Related Links

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Margret Leosdottir, MD, PhD

    Skane University Hospital and Lund University, Malmo, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

August 24, 2017

Study Start

April 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

SE(3)