Impact of Mobile Health in Improving Lifestyle and Therapeutic Adherence in Coronary Heart Disease

NCT05247606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-05-10

No results posted yet for this study

Summary

Cardiovascular diseases are the leading cause of death worldwide. In high-income countries, approximately seventy percent of cardiovascular diseases cases are attributable to modifiable risk factors, with metabolic risk factors (obesity, cholesterol) and tobacco use being the most closely associated.

Secondary prevention of coronary disease is considered essential, since it has contributed significantly to the reduction of morbidity and mortality, by facilitating the adoption and adherence to healthy behaviors, promoting an active lifestyle, and increasing adherence to pharmacological treatment.

Information and communication technologies have been increasingly incorporated into health care systems, including the innovative provision of Cardiac Rehabilitation through a mobile phone or m-health interventions. M-health technology can provide evidence-based guidance in an interactive format that is attractive, easy to use, and reduces healthcare costs.

The objective of this study is to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a web application of health, mobile Health, on lifestyle (diet, physical activity, and nicotine dependence) and therapeutic adherence in people with coronary heart disease.

The sample will consist of 200 participants, 100 in the intervention group and 100 in the usual care group that will be evaluated at the beginning and 3, 6, and 12 months after hospital discharge regarding sociodemographic, clinical, cardiovascular risk factors, lifestyle, and therapeutic adherence characteristics. The educational intervention, monitoring, and self-monitoring will be carried out using a web-based m-Health tool, mobile phone application. The quantitative primary results will be compared between the two groups using analysis of covariance, adjusting for age and sex. Multivariate analysis will be carried out to examine the association of the intervention with life habits, control of cardiovascular risk factors as well as the evolution after discharge in respect of cardiovascular events, emergency and re-entry views.

Conditions

  • Coronary Disease

Interventions

DEVICE

Mobile application

Lifestyle intervention through web-based mobile application

Sponsors & Collaborators

  • University of Cadiz

    lead OTHER

Principal Investigators

  • MJ Santi, MD · University of Cadiz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247606 on ClinicalTrials.gov