Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05247606 |
| Other study ID # |
PI-0014-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Cadiz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Design: A randomized single-blind, parallel-group, controlled clinical trial performed on
patients with coronary heart disease who underwent a percutaneous coronary intervention with
stent placement in the Cardiology Service of a public reference hospital complex providing
specialist care in the province of Cadiz, Spain, in which 1500 coronary interventions
procedures are performed per year.
Randomization and Blinding: The randomization and allocation to each group (1:1, intervention
and usual care) are based on computer-generated random numbers. The researchers responsible
for the study do not participate in the allocation of the participants. Due to the kind of
intervention, blinding is not possible when the participants are allocated to groups. To
minimize any bias, objective clinical variables are measured in the evaluation visit and the
analyses are performed by blinded researchers.
Study Sample: The participants are eligible to participate if they have a confirmed diagnosis
of coronary heart disease and undergo percutaneous coronary intervention. Furthermore, the
participants must comply with the criteria explained in the section.
Sample Size: To detect a medium effect size of Cohen's d of 0.5 regarding adherence to the
Mediterranean diet (8.6 ± 2.0 points), physical activity (216 ±92 minutes/day), nicotine
dependence (1.50± 2.14 points), and therapeutic adherence (6.47±1.23 points), a 95%
confidence interval and a power of 80%, the sample size is estimated at 80 patients in each
group. Assuming a 20% loss to follow-up, 200 participants will be recruited, 100 in each arm,
intervention and usual care.
Recruitment: After the percutaneous coronary intervention and during admission, the nurse
will recruit eligible patients and their care partners, will ask them to sign the informed
consent, perform the initial assessment and organize a programmed visit after 3,6 and 12
months. A card will be provided with the dates of the appointments and a telephone number for
any changes.
The participants allocated to the usual care group receive the standard prescribed care and
advice about medication, and lifestyle.
Both groups will be provided with written recommendations and an explanation about the
standard Mediterranean diet, physical activity, stopping smoking and treatment adherence.
Before hospital discharge, all the patients will be encouraged to follow a healthy lifestyle.
Stages of change strategies will be used in addition to a motivational and behavior changing
interview. Written information will be provided about risk factors, lifestyle goals, a
suggested healthy menu, recommendations about the daily intake of food groups, and the other
behavior that the intervention is targeting.
Intervention: The intervention begins during the patient's stay in hospital immediately after
a coronary event. The participants from the intervention group and their partner/carer will
complete a short online tutorial describing the mobile application accessed using a mobile
telephone or tablet. They will be advised to use the application for at least 15 min per day.
This time has been considered sufficient for the daily recording of data in the pilot study.
The intervention and follow-up will last 12 months. If the patient does not record data for a
week, he/she receives a message through the app encouraging him to use it. The patients may
resolve any queries using the application's built-in messaging function, to which the nurse
will reply through this messaging service or with a telephone call. This avoids many patient
visits to the doctor for consultations and reduces human resource needs.
Before the trial, a pilot study was performed with 20 participants to test the application
and make any necessary adjustments.
Technical Data of the Website and Application: The responsive online application (user
registration, data management, downloading records) is managed via the project website, which
acts as an access platform after validation with a password. The web environment enables the
application to be executed using any browser. Operating environment: it is an application
with remote access to a My Structured Query Language (MySQL) database. Technology
development: (a) uses Personal Home Page (PHP ) scripting language ; (b) Asynchronous
JavaScript and XML (AJAX) web development techniques. The application runs in the user's
browser while it communicates with the server in the background; and (c) Bootstrap
open-source tools for designing websites and online applications. Data storage: MySQL
database is fast enough to deploy web applications. Data protection: in addition to on-demand
backups performed by the software, the web server performs daily backups of all the files, so
the data and program are doubly protected. Access privacy: The data are not stored in a local
computer but on a web server, meaning they can only be accessed with a password. This web
server works with anonymous data and is located in the country to comply with the regulations
for the protection of high-level data.
Application Contents: The application has educational texts and videos on healthy lifestyle
and therapeutic adherence and allows users to set goals and monitor their food consumption,
physical exercise, blood pressure, tobacco use, and compliance with their treatment. It is
based on the phases of change theory (attention, retention, memory, action, and motivation),
and on making the process pleasing. The user's attention is caught through warnings and
bright, attractive colors on the user interface; retention is encouraged by reminders,
repetition, and graphs; action is prompted by instructions, advice, and feedback; and
motivation to change is boosted by internal comparisons (progress graphs), setting goals,
self-monitoring, and feedback. Through its different components participants are encouraged
to (1) follow a healthy eating pattern based on the Mediterranean diet aligned with national
dietary guidelines; (2) perform a physical activity of duration and intensity in line with
the recommendations of their cardiologist; (3) stop smoking; (4) monitor their blood
pressure; (5) adhere to their treatment by associating taking medication with daily
activities, establishing set times for taking it and with support from a relative, etc.
Components of the Application: A) Provide information encouraging a healthy lifestyle.
Through the website, the participants will have access to information on their screens that
they can print to help them plan a healthier lifestyle and adhere to their treatment. The
application also has a training section for the patient with videos and information about the
recommended therapeutic objectives in the clinical practice guidelines regarding food,
physical activity, body weight, blood pressure, blood sugar, stopping smoking and adhering to
treatment.
B) Self-monitoring. The application has a recording and self-checking function to help
patients to self-monitor the skills for each behavioral goal about nutrition, physical
activity, tobacco consumption, blood pressure, body weight, capillary blood glucose in
patients with diabetes mellitus and treatment adherence.
Training: Session about the Application for patient and carer. The nurse will install the
shortcut to the application on the screen of the participant's mobile phone and will record
the prescribed treatment including the name, dose, and timetable in the application. The
nurse will update the prescription in the application if the doctor changes the treatment.
During the training session, the participants learn to use the functions of the application:
confirm when medication is taken, record the food consumed and physical activity performed
(daily), blood pressure, weight, and tobacco consumption (weekly), and capillary blood
glucose in participants with diabetes mellitus (twice a week). The participants can follow
their evolution and progress through the graphics generated with the information they have
recorded over the previous weeks.
Ethical Considerations:The study will be conducted in agreement with the guidelines and
protocols established in the Helsinki Declaration as revised in Fortaleza (Brazil) in October
2013, and complies with Law 14/2007 on Biomedical Research and with European Data Protection
Regulations. The Biomedical Research Ethics Committee of the Costa del Sol, Andalusian,
approved the project with the reference: 002_jun20_PI-RECAMAR-19. The informed written
consent of all the patients will be requested. The application guarantees the security
measures regarding the current General Data Protection Regulations in Europe. It also
includes data encryption mechanisms.
