NCT05247606

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 3, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

February 3, 2022

Last Update Submit

May 9, 2024

Conditions

Coronary Disease

Keywords

Coronary DiseaseMobile applicationLifestyleClinical trial

Outcome Measures

Primary Outcomes (7)

  • Change in Adherence to the Mediterranean diet

    A 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.

    Month 3, 6 and 12

  • Change in Frequency of food consumption

    A Food-frequency questionnaire with 20 food items (unit of measure: number of times per month, week and day

    Month 3, 6 and 12

  • Change in Level of physical activity

    International Physical Activity Questionnaire (IPAQ) (unit of measure: minutes of exercise/ day. Minimum: Walk at least 30 minutes a day, 5 times a week (150 minutes a week). Do higher values represent a better outcome.

    Month 3, 6 and 12

  • Change in Test for nicotine dependence

    (Unit of measure: points. Less than 4 points, low dependency; between 4 and 6 points, medium dependency; equal to or greater than 7 points, high dependency).

    Month 3, 6 and 12

  • Change in Therapeutic adherence

    A 8 items questionnaire (Total score: 8 points. Good therapeutic adherence= 8 points. Poor therapeutic adherence= 1-7 points)

    Month 3, 6 and 12

  • Change in Knowledge about cardiovascular disease using a questionnaire

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

    Month 3, 6 and 12

  • Change in Usability and satisfaction with the application

    A 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)

    Month 3, 6 and 12

Study Arms (2)

Intervention group

EXPERIMENTAL

Mobile application

Device: Mobile application

Control group

NO INTERVENTION

Usual care

Interventions

Mobile applicationDEVICE

Lifestyle intervention through web-based mobile application

Intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 and with internet access

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Related Publications (2)

  • Cruz-Cobo C, Bernal-Jimenez MA, Calle G, Gheorghe LL, Gutierrez-Barrios A, Canadas D, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial. JMIR Mhealth Uhealth. 2024 Jul 25;12:e55421. doi: 10.2196/55421.

    PMID: 39052330DERIVED

  • Cruz-Cobo C, Bernal-Jimenez MA, Calle-Perez G, Gheorghe L, Gutierrez-Barrios A, Canadas-Pruano D, Rodriguez-Martin A, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Impact of mHealth application on adherence to cardiac rehabilitation guidelines after a coronary event: Randomised controlled clinical trial protocol. Digit Health. 2024 Mar 19;10:20552076241234474. doi: 10.1177/20552076241234474. eCollection 2024 Jan-Dec.

    PMID: 38510574DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • MJ Santi, MD

    University of Cadiz

    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

February 3, 2022

First Posted

February 21, 2022

Study Start

March 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)