Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601478
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Development and Implementation of a Tool for the Evaluation and Monitoring of the Mediterranean Lifestyle in the Clinical Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle At Clinical Settings MEDLIFE Index a Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MedLIFE
Brief Summary:
The main goal is to develop a health online app based on a Mediterranean lifestyle score diet cooking preferences rest physical activity social habits conviviality and its implementation in clinical settings with patients that have suffered from a cardiovascular event This is a pilot study that will allow an integral assessment of health as an attempt to decrease obesity one of the main risk factors of cardiovascular disease as well as to improve the prevention of secondary events
The main goal involves the following specific objectives
Developing and transferring the previously validated questionnaire in Spanish population MEDLIFE index MEDiterranean LIFEstyle to evaluate adherence to a Mediterranean lifestyle an online app that allows
To evaluate and to monitor the adherence to the MEDLIFE throughout time
To use the MEDLIFE online app to obtain customized recommendations according to the results an instantaneous generation of a resume of results
To start conversations between patient and health workers to improve patients lifestyles obesity or related parameters and cardiovascular health
To keep information in a safe way that will allow it to be linked to other health indicators
Conducting a qualitative study using personal interviews with health providers and patients to evaluate acceptation feasibility barriers or limitations when using the MEDLIFE app in clinical practice aiming for the apps enhancing
Conducting a pilot study of implementation of MEDLIFE in clinical settings in patients with a cardiovascular event myocardial infarction ictus angina ischemic cardiopathy n 80-100 trying parity between men and women
This is the projects intervention part
To evaluate changes in MEDLIFE and its components anthropometric and biochemical measurements between baseline 3-month 6-month and 8-month follow-up
Following participants by means of revision of medical reports and clinical histories to register future cardiovascular events dynamic
The main goal involves the following specific objectives
Developing and transferring the previously validated questionnaire in Spanish population MEDLIFE index MEDiterranean LIFEstyle to evaluate adherence to a Mediterranean lifestyle an online app that allows
To evaluate and to monitor the adherence to the MEDLIFE throughout time
To use the MEDLIFE online app to obtain customized recommendations according to the results an instantaneous generation of a resume of results
To start conversations between patient and health workers to improve patients lifestyles obesity or related parameters and cardiovascular health
To keep information in a safe way that will allow it to be linked to other health indicators
Conducting a qualitative study using personal interviews with health providers and patients to evaluate acceptation feasibility barriers or limitations when using the MEDLIFE app in clinical practice aiming for the apps enhancing
Conducting a pilot study of implementation of MEDLIFE in clinical settings in patients with a cardiovascular event myocardial infarction ictus angina ischemic cardiopathy n 80-100 trying parity between men and women
This is the projects intervention part
To evaluate changes in MEDLIFE and its components anthropometric and biochemical measurements between baseline 3-month 6-month and 8-month follow-up
Following participants by means of revision of medical reports and clinical histories to register future cardiovascular events dynamic
Detailed Description:
Participants will be selected from the clinical cardiology and cardiac rehabilitation or internal medicine services Each physician will recruit patients from among those assigned to his or her practice just as they are discharged from the hospital after a cardiovascular event
The online application will be suitable for tablet mobile and web use For its development a specialist webapp development company will be contracted and will follow the indications of the research team
The application visually attractive should allow a quick and easy evaluation of MEDLIFE and in addition include interactive features that raise awareness and motivate users to change their health habits Thus when the participant has completed the questionnaire a results page will be automatically generated with a color scale to indicate what needs to be improved red indicating a factor to be considered for improvement green the recommendations are met and the participant is performing adequately Also specific recommendations will be provided to achieve the objectives of those factors that can be improved In this way the results will be ready to be evaluated and discussed with the healthcare professional The design of the app will be inclusive to allow the use of the app by people with certain disabilities it will allow the questions to be read by a voice audio for people with disabilities vision loss or illiterate This objective will be carried out with the help of a computer technician specialized in the development of mobile applications and web pages
In addition physicians will be able to monitor their patients at each visit entering themselves the data obtained from MEDLIFE as well as anthropometric and analytical parameters All this information entered into the app will be available for research use by the researchers for the project in an anonymized form
The data will be stored in a secure password-protected Firebase system to allow data analysis and tracking A consent medical disclaimer and privacy policy will be included in the app
The online application will be suitable for tablet mobile and web use For its development a specialist webapp development company will be contracted and will follow the indications of the research team
The application visually attractive should allow a quick and easy evaluation of MEDLIFE and in addition include interactive features that raise awareness and motivate users to change their health habits Thus when the participant has completed the questionnaire a results page will be automatically generated with a color scale to indicate what needs to be improved red indicating a factor to be considered for improvement green the recommendations are met and the participant is performing adequately Also specific recommendations will be provided to achieve the objectives of those factors that can be improved In this way the results will be ready to be evaluated and discussed with the healthcare professional The design of the app will be inclusive to allow the use of the app by people with certain disabilities it will allow the questions to be read by a voice audio for people with disabilities vision loss or illiterate This objective will be carried out with the help of a computer technician specialized in the development of mobile applications and web pages
In addition physicians will be able to monitor their patients at each visit entering themselves the data obtained from MEDLIFE as well as anthropometric and analytical parameters All this information entered into the app will be available for research use by the researchers for the project in an anonymized form
The data will be stored in a secure password-protected Firebase system to allow data analysis and tracking A consent medical disclaimer and privacy policy will be included in the app
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None