Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04118504 |
| Other study ID # |
PI-0067-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Instituto de investigación e innovación biomédica de Cádiz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Design
1. A randomized single-blind, parallel-group, controlled clinical trial performed on
patients with coronary heart disease who underwent a percutaneous coronary intervention
(PCI) 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.
2. 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.
3. Study Sample The participants are eligible to participate if they have a confirmed
diagnosis of coronary heart disease and undergo stenting with PCI. Furthermore, the
participants must comply with the criteria explained in the section.
4. 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 puntos), food consumption, vegetables (471.4 g/day ±
230.0 g/day), fruit (308.4 g/day ± 188.6 g/day), meat and derived products (149.7 g/day
± 63.7 g/day), fish (122.3 g/day ± 73.5 g/day), physical activity (210.2 METs-min/day
-metabolic equivalents- ±221.8 METs-min/day) and a 12% decrease in smoking habits
(prevalence of 21% in pilot study), a 95% confidence interval and a power of 90%, the
sample size is estimated at 100 patients in each group. Assuming a 20% loss to follow-up
with 240 participants, 120 in each arm: intervention and usual care.
5. Recruitment After the PCI 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 36 weeks. A card will be provided with
the date of the appointment 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.
6. 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 will last 36 weeks. 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.
7. 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 MySQL (My Structured Query Language) database.
Technology development: (a) uses PHP scripting language (Personal Home Page Tools); (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.
8. Application Contents The application 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 (website, messages, emails, and calls), participants
are encouraged to (1) follow a healthy eating pattern based on the Mediterranean diet
aligned with national dietary guidelines; (2) perform 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.
9. 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 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.
10. 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 eight weeks.
11. 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. It was approved by the Biomedical Research Ethics Committee
of the Costa del Sol, Andalusian, with the reference: 003_ene19_PI-EVITE-18. 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.
