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Intervention in Lifestyle and Therapeutic Adherence After Coronary Event Based on Web Application

NCT04118504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-08-08

No results posted yet for this study

Summary

Ischemic heart disease is the most frequent cause of mortality in the surrounding countries. Once a coronary event is over, there is a high risk of readmission, recurrence and, mortality, attributed to a sub-optimal control of cardiovascular risk factors (CVRF), highlighting the need to improve secondary prevention strategies aimed at changing lifestyle and therapeutic adherence. Preventive measures should be initiated during hospitalization as recommended by the clinical guidelines. 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 (e-Health) on lifestyle (diet, physical activity and tobacco consumption) and medication adherence in people with coronary heart disease after percutaneous coronary intervention.

The sample will consist of 240 participants, 120 in the intervention group and 120 in the usual care group that will be evaluated at the beginning and nine months after hospital discharge regarding sociodemographic, clinical, CVRF, lifestyle and therapeutic adherence characteristics. The educational intervention, monitoring and self-monitoring will be carried out using a web-based e-Health tool, mobile phone application. The quantitative primary results will be compared between the two groups using ANCOVA adjusting for age and sex. Multivariate analysis will be carried out to examine the association of the intervention with life habits, control of CVRF, as well as with the evolution after discharge in respect of cardiovascular events, emergency and re-entry views.

Conditions

  • Coronary Disease

Interventions

DEVICE

Mobile application

Lifestyle intervention on through mobile application

Sponsors & Collaborators

  • Instituto de investigación e innovación biomédica de Cádiz

    lead OTHER

Principal Investigators

  • MJ Santi, MD · Instituto de investigación e innovación biomédica de Cádiz

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
2020-07-30
Primary Completion
2021-09-30
Completion
2022-06-30

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 NCT04118504 on ClinicalTrials.gov