What is the clinical evidence from this study?

Study design: RCT. Population: Myocardial Infarction (n=150). Intervention: LifePod web-based application vs. Usual care (center-based cardiac rehabilitation only). Primary outcome: Change in submaximal exercise capacity (Watts) between 2-4 weeks and 4-6 months (95% CI -12.0 to 2.8, p=0.22).

December 28, 2021Open Access

Effect of a Lifestyle-Focused Web-Based Application on Risk Factor Management in Patients Who Have Had a Myocardial Infarction: Randomized Controlled Trial

Key Result

Complementing cardiac rehabilitation with a web-based application resulted in a nonsignificant trend toward a larger change in exercise capacity compared with usual care (+14.4 W vs +10.3 W).

Study Design

Type

RCT (n=150)

Blinding

Open-label

Randomization

Opaque sealed envelopes

Multicenter

Yes

Structured PICO

Does adding a lifestyle-focused web-based application to standard cardiac rehabilitation improve submaximal exercise capacity and risk factor management in patients who have recently had a myocardial infarction?

Population

150 adults aged 18-74 years who had a myocardial infarction within the last 2 weeks, followed for 25 weeks.

Intervention

LifePod web-based mobile device application for 25 weeks (allowing patients to log diet, physical activity, weight, heart rate, blood pressure, smoking, and symptoms, while providing automated feedback and lifestyle advice) added to a comprehensive center-based cardiac rehabilitation program.

Comparator

Usual care consisting of a comprehensive center-based cardiac rehabilitation program only (5 outpatient follow-up visits with a nurse, physician, and physiotherapist).

Outcome

Change in submaximal exercise capacity (measured in Watts) between two submaximal exercise tests performed on a bicycle ergometer at 2 to 4 weeks and at 4 to 6 months.surrogate

Main Result

Absolute Event Rate: 14.4% vs 10.3%

p-value: p=0.22

Limitations

Unblinded study design
Missing data for the primary outcome as not all patients completed the submaximal exercise tests
Adherence to the web-based application declined over the 25-week intervention period
Self-reported data for dietary and physical activity outcomes
Low number of smokers limited statistical power for smoking cessation outcomes

Abstract

BACKGROUND: Cardiac rehabilitation is central in reducing mortality and morbidity after myocardial infarction. However, the fulfillment of guideline-recommended cardiac rehabilitation targets is unsatisfactory. eHealth offers new possibilities to improve clinical care. OBJECTIVE: This study aims to assess the effect of a web-based application designed to support adherence to lifestyle advice and self-control of risk factors (intervention) in addition to center-based cardiac rehabilitation, compared with cardiac rehabilitation only (usual care). METHODS: All 150 patients participated in cardiac rehabilitation. Patients randomized to the intervention group (n=101) received access to the application for 25 weeks where information about lifestyle (eg, diet and physical activity), risk factors (eg, weight and blood pressure BP), and symptoms could be registered. The software provided feedback and lifestyle advice. The primary outcome was a change in submaximal exercise capacity (Watts W) between follow-up visits. Secondary outcomes included changes in modifiable risk factors between baseline and follow-up visits and uptake and adherence to the application. Regression analysis was used, adjusting for relevant baseline variables. RESULTS: There was a nonsignificant trend toward a larger change in exercise capacity in the intervention group (n=66) compared with the usual care group (n=40; +14.4, SD 19.0 W, vs +10.3, SD 16.1 W; P=.22). Patients in the intervention group achieved significantly larger BP reduction compared with usual care patients at 2 weeks (systolic -27.7 vs -16.4 mm Hg; P=.006) and at 6 to 10 weeks (systolic -25.3 vs -16.4 mm Hg; P=.02, and diastolic -13.4 vs -9.1 mm Hg; P=.05). A healthy diet index score improved significantly more between baseline and the 2-week follow-up in the intervention group (+2.3 vs +1.4 points; P=.05), mostly owing to an increase in the consumption of fish and fruit. At 6 to 10 weeks, 64% (14/22) versus 46% (5/11) of smokers in the intervention versus usual care groups had quit smoking, and at 12 to 14 months, the respective percentages were 55% (12/22) versus 36% (4/11). However, the number of smokers in the study was low (33/149, 21.9%), and the differences were nonsignificant. Attendance in cardiac rehabilitation was high, with 96% (96/100) of patients in the intervention group and 98% (48/49) of patients receiving usual care only attending 12- to 14-month follow-up. Uptake (logging data in the application at least once) was 86.1% (87/101). Adherence (logging data at least twice weekly) was 91% (79/87) in week 1 and 56% (49/87) in week 25. CONCLUSIONS: Complementing cardiac rehabilitation with a web-based application improved BP and dietary habits during the first months after myocardial infarction. A nonsignificant tendency toward better exercise capacity and higher smoking cessation rates was observed. Although the study group was small, these positive trends support further development of eHealth in cardiac rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03260582; https://clinicaltrials.gov/ct2/show/NCT03260582. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-3118-1.

Mark Helpful

Bookmark

Relay

View Full Paper