PreDiabeText

TITLE OF THE STUDY: Development and evaluation of a low-intensity, multifaceted digital health intervention to prevent type 2 diabetes mellitus in primary care: the PREDIABETEXT study
SPONSOR CODE: SYN20/04
SPONSOR: Health Research Institute of the Balearic Islands (IdISBa)
PRINCIPAL INVESTIGATORS: Ignacio Ricci Cabello and Escarla Angullo
INSTITUTION: Health Research Institute of the Balearic Islands (IdISBa)

Introduction

We are contacting you regarding a study we would like to invite you to participate in. The study has been approved by the Research Ethics Committee of the Balearic Islands, in accordance with current legislation, and is being conducted in compliance with the principles outlined in the Declaration of Helsinki and good clinical practice guidelines. The purpose of this document is to provide you with the necessary information so that you can decide whether or not you wish to participate in this study. Please read this information sheet carefully, and we will clarify any questions that may arise after the explanation. If you have any questions, you can contact the principal investigator of the study (Ignacio Ricci Cabello, phone: 971 175883; ignacio.ricci@ssib.es)

General description

The aim of this study is to develop a new text message (SMS) service targeted at individuals at higher risk of developing type 2 diabetes in the coming years. Through this service, these individuals will receive free text messages on their mobile phones with recommendations to help prevent the onset of diabetes. These recommendations have been prepared by a group of experts that includes family doctors, nutritionists, psychologists, and physical activity experts. The main goal of these messages is to encourage the adoption of healthy lifestyles, with a particular focus on diet and physical activity. Through this study, we aim to understand to what extent this text message service can help individuals improve their lifestyles and prevent the onset of diabetes. Participants in this study will be randomly assigned to two groups: the intervention group and the control group. Only participants in the intervention group (approximately 70% of participants) will receive the text messages previously described. Participants assigned to the control group (around 30%) will not receive any text messages or additional information. The allocation of patients to either group will be done through a computer program, following the initial evaluation visit described below.

What would participating in this study mean for me?

Your participation in this study would involve:

1. Attend the Son Espases University Hospital or a primary care center of the Health Service, where you will have an appointment with a nurse from our study. During this appointment, the nurse will assess your lifestyle habits (through a series of standardized questions) and your health status. A blood sample will also be taken, as well as a urine sample, and your weight and height will be measured. All participants (both from the control group and the intervention group) will need to attend this visit.
2. Receive and read the text messages. These are short messages, containing a maximum of 160 characters. You would receive them completely free of charge on your own mobile phone. You would receive a maximum of three messages per week, for a period of 6 months. These messages will only be received by participants in the intervention group.
3. After 6 months, you will need to visit the Son Espases University Hospital or a primary care center of the Health Service, where another appointment with a nurse from our study will take place. The purpose of this appointment will be the same as described in point 1. All patients (both from the control and intervention groups) must attend this visit.

Benefits and Risks of Participating in the Study

Participation in this study could help you better understand how to prevent diabetes, which we believe could be useful for improving your health. Even if this is not the case, your participation could contribute to designing a service that is as useful as possible in helping people at risk of diabetes prevent the disease.
The only risk associated with your participation in the study is related to the blood extraction process. Although it will be carried out by an experienced nurse, occasionally the needle insertion may cause some pain and slight redness or swelling at the site of the puncture.

CONFIDENTIALITY

• Data Processing Responsible: Dr. Ignacio Ricci Cabello (Primary Care Management of Mallorca, Carrer de l’Escola Graduada, 3, 07002 Palma, Illes Balears. 971175897; ignacio.ricci@ssib.es) and Dr. Escarlata Angullo Martínez (escarlata.angullo@ibsalut.es; 971717047).
• Data Protection Officer (DPO): You can make any inquiries regarding this processing to the Data Protection Officer of the research sponsoring organization, the Fundació Institut d’Investigació Sanitària Illes Balears (IdISBa), which is located at Crta. Valldemossa, 79 (Hospital Universitari Son Espases), Building S, 1st floor, 07010 Palma de Mallorca. Data Protection Officer: idisba.protecciondatos@ssib.es
• Purpose of Data Collection: Your personal data will be processed for scientific research purposes, studies, trials, programs, and educational activities, in order to develop functions related to health promotion, disease prevention, teaching, and as a complement to the necessary healthcare activities of public healthcare system centers, as well as for epidemiological research and similar activities.
• Recipients of the Information: There is no planned communication of your personal data to third parties.
• Maximum retention period of data: The data will be kept for as long as necessary to fulfill the purpose for which it was collected and to determine any potential liabilities arising from that purpose and the processing of the data. However, the maximum retention period is set to five years from the date the informed consent was obtained.

The processing, communication, and transfer of personal data of all participants will comply with the provisions of Organic Law 3/2018, of December 5, on the protection of personal data and the guarantee of digital rights. In accordance with the mentioned legislation, you have the right to exercise access, rectification, deletion, opposition, restriction of data processing, and even the portability of your data to an authorized third party. To do so, you must contact the principal investigator responsible for data processing at the following addresses: Gerencia de Atención Primaria de Mallorca, Carrer de l’Escola Graduada, 3, 07002 Palma, Illes Balears, 971175897; ignacio.ricci@ssib.es.
Your data will be processed electronically and incorporated into an automated personal data system that complies with all access security measures restricted to the purpose described in this document. To ensure the confidentiality of the information obtained, your data will be identified by a code, and only the study investigators and collaborators will be able to link this data with you and your clinical history. Therefore, your identity will not be disclosed to anyone except in cases of medical emergencies, requests from the health administration, or legal requirements. Only data necessary for conducting the study, and that will not contain any information that could directly identify you, such as your name, surname, initials, address, Social Security number, etc., will be transmitted to third parties and other countries. If such a transfer occurs, it will be for the same purposes as the study and ensuring confidentiality at a level equivalent to the protection provided by current legislation in our country.
Access to your personal information will be restricted to the principal investigator of the study, collaborators, health authorities, the Ethics Committee for Research in the Balearic Islands, and authorized personnel, when necessary to verify data and study procedures, but always maintaining confidentiality according to current legislation.
Additionally, you may make any inquiries about this processing to the Data Protection Delegation of the research-promoting organization, the Fundació Institut d’Investigació Sanitària Illes Balears (IdISBa), located at Crta. Valldemossa, 79 (Hospital Universitari Son Espases), Building S, 1st floor. 07010 Palma de Mallorca. Data Protection Delegate: idisba.protecciondatos@ssib.es.
In any case, you can address any complaints related to the processing of your personal data to the Spanish Data Protection Agency.

Monetary compensation

Participation in this study does not involve any type of monetary compensation.

Voluntary participation.

You should know that your participation in this study is voluntary, and you can choose not to participate or change your mind and withdraw your consent at any time, without providing any explanation, and without affecting your relationship with your health center or with the Primary Care Management. To revoke your consent, you should contact the Principal Investigator (Ignacio Ricci Cabello, phone 971 175883; ignacio.ricci@ssib.es). If you decide to withdraw your consent, no new data will be collected, nor will new analyses of the sample be conducted, but this withdrawal will not affect the research already completed up to that point.

Appretiation

Regardless of your decision, both the sponsor and the research team would like to express their gratitude for your time and attention.