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

NCT04118504 | Completed

• 1 other identifier: PI-0067-2018
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary disease; Life style; Mobile application; Clinical trial

Outcome Measures

Primary Outcomes (7)

• Adherence to the Mediterranean diet

  14-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 14 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet.

  9 months

• Frequency of food consumption

  Food-frequency questionnaire with 137 food items (unit of measure: number of times per month, week and day)

  9 months

• Level of physical activity

  Minnesota Leisure Time Physical Activity Questionnaire (unit of measure: Metabolic equivalents-minutes per day. Minimum: 150 metabolic equivalents-minutes per day; active, those with energy expenditure in physical activity equal or greater than 150 metabolic equivalents-minutes per day). Do higher values represent a better outcome.

  9 months

• The concentration of carbon monoxide in exhaled air

  Smoking cessation: Value \< 6 parts per million of carbon monoxide in exhaled air. Smoker: Value \> 6 parts per million of carbon monoxide in exhaled air.

  9 months

• Therapeutic adherence

  A 4 items questionnaire (Total score: 4 points. Good therapeutic adherence= 4 points.Poor therapeutic adherence= 1-3 points)

  9 months

• Knowledge about cardiovascular disease using a questionnaire

  24-item questionnaire (scale 0-5 each item. Do higher values represent a better outcome)

  9 months

• Usability and satisfaction with the application: 22 item questionnaire

  22 item questionnaire to assess user acceptability of mobile health interventions. (6-point scale, level of disagreement to agreement with each item concerning the usability of the apps. Do higher values represent a better outcome)

  9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Lifestyle intervention on through mobile application

Device: Mobile application

Control group

NO INTERVENTION

Usual care

Interventions

Mobile application DEVICE

Lifestyle intervention on through mobile application

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with coronary heart disease
• Under the age of 75
• Have a mobile phone
• with the ability to receive text messages
• with internet access

You may not qualify if:

• Severe heart failure
• Physical disability
• Dementia
• Congenital heart disease
• Rheumatic etiology disease

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz: lead

Study Sites (1)

Hospital Puerta del Mar

Cadiz, 11010, Spain

Location

Related Publications (1)

• Bernal-Jimenez MA, Calle G, Gutierrez Barrios A, Gheorghe LL, Cruz-Cobo C, Trujillo-Garrido N, Rodriguez-Martin A, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Apr 22;12:e48756. doi: 10.2196/48756.

  PMID: 38648103 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• MJ Santi, MD

  Instituto de investigación e innovación biomédica de Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 8, 2019
• Study Start: July 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)