Randomized Clinical Trial to Assess the Efficacy of a Mobile Application to Help in Weight Loss Before Bariatric Surgery: the VAMOS Project (Virtual Accompaniment for Morbid Obesity Surgery)
Phase: NA
Conditions: Morbid Obesity, Weight Loss
Sponsor: Hospital Universitari de Bellvitge

STUDY PROTOCOL 
 
 
Randomized Clinical Trial to assess the safety and efficacy of a mobile 
application to accompany and empower patients undergoing bariatric 
surgery: the VAMOS project (Virtual Accompaniment for Morbid Obesity 
Surgery) 
Principal investigator: 
Dr. JAVIER OSORIO 
Servicio de Cirugía General y Digestiva 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
Tel.: +34. 93 2607623 
 
 
PROTOCOL CODE: HUB-CIR-VAMOS 
 
 
RESEARCHERS: 
 
Dr. Claudio LAZZARA 
Servicio de Cirugía General y Digestiva 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
Tel.: +34. 93 2607623 
 
Dra. Lucía SOBRINO 
Servicio de Cirugía General y Digestiva 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
Tel.: +34. 93 2607623 
 
 
 
 
 
Versión of 09-july- 2022 
The information contained in this document is strictly confidential and can only be used for review by the Researchers, 
the Research Ethics Committees and the competent Authorities. Reproduction, transmission or copying, in any 
medium, in whole or in part, without the prior authorization of the Promoter or an authorized representative is 
prohibited. 

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SIGNATURE Principal investigator: 
I have read and agree to the protocol titled: “Randomized Clinical Trial to assess the safety and efficacy of a mobile 
application to accompany and empower patients undergoing bariatric surgery: the VAMOS project (Virtual 
Accompaniment for Morbid Obesity Surgery)”. 
 
I am informed of my responsibilities as Principal Investigator under Good Clinical Practice (GCP) standards, local legislation 
and the study protocol. I agree to conduct the study in accordance with these standards, and to properly direct and assist 
the team under my charge that will conduct the study. 
 
Principal investigator 
 
Signature: Dr. JAVIER OSORIO 
Date  09/07/2022 

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1. RESUME 
 
Principal Investigator name: 
Dr. Javier OSORIO 
 
 
STUDY TITLE: Randomized Clinical Trial to assess the safety and efficacy of a mobile application to 
accompany and empower patients undergoing bariatric surgery: the VAMOS project (Virtual 
Accompaniment for Morbid Obesity Surgery) 
STUDY TYPE: Randomized Clinical Trial 

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INTRODUCTION: 
 
Morbid obesity is considered the great epidemic of our century. It is regarded as the first non-traumatic cause of death 
in the western population and it is also progressively beginning to affect developing countries. The latest epidemiological 
studies estimate that in Spain more than 15% of the population has overweight and about 5% has morbid obesity. 
 
Obesity treatment is multidisciplinary, from lifestyle and dietary changes to surgery. Amongst the different available 
treatments, bariatric surgery is the only cost-effective in patients with morbid obesity. Bariatric surgery provides better 
results compared to both pharmacological treatments (which are less available and less effective) and lifestyle changes. 
Furthermore, as well as weight loss, it guarantees a better control of comorbidities, reducing the risk of cardiovascular 
disease, morbidity and mortality, improving quality of life. 
 
Although surgery is the best treatment option, patient commitment is necessary to achieve satisfactory results. 
Obtaining patient’s comprehension of the importance of healthy lifestyle and equilibrated diet alongside with surgical 
information is generally difficult. Patient’s concern needs to be constantly stressed out. The ongoing protocols that 
include preoperative meetings with surgeons, endocrinologists and nutritionists have been proved as insufficient, 
especially during the Covid-19 pandemic, when presential visits were reduced or cancelled. 
Preoperative optimization with a healthy lifestyle and a balanced diet few months before surgery potentially reduce 
intraoperative complications alongside with postoperative morbidity and mortality [1-3]. Level of physical activity, diet 
and psychological stability could affect surgery’s outcome for example reducing liver volume (up to 20%) and mesenteric 
fat [4-13]. Also, an improvement in patient’s preoperative satisfaction, anxiety and commitment to surgery have been 
suggested [14-16]. Their impact on postoperative outcomes is unclear. There is lack of consensus on a standardized 
preoperative approach and goals. Many health care professionals worldwide strongly believe that preoperative 
optimization has an important impact on postoperative outcomes, but the evidence supporting this belief is mixed and most 
often retrospective. Although a positive relationship between self-monitoring behaviors (such as daily food intake diaries 
and regular self-weighing) and weight loss has been proved, additional instruction and behavioral intervention are 
needed. Besides weight loss, other factors such as adherence to self-monitoring of weight, recording food intake, 
increased physical activity could influence postoperative outcomes [17]. 
 
Even though official guidelines for an enhanced recovery (ERAS, Enhanced Recovery After Surgery) in bariatric surgery 
recommend patient information, education, counseling and preoperative weight loss, the efficacy of these measures 
has not been proved [18]. 
 
Technological development is an important resource that could help improving communications between patients and 
health care professionals. Nowadays, the use of a smartphone is widely integrated in daily life of most people [19,20]. 
The number of smartphones used is constantly increasing every year. In 2016, there were more than seven billion users 
worldwide [21]. The worldwide fast widespread of mobile technology in the last 15 years led to an expansion of the 
applications (APP) market [22]. To date, the biggest APP market are ‘Google Play’ (Android), ‘App store’ (Apple) and 
‘Blackberry World’ (Blackberry) [23]. 
 
This technological revolution has progressively affected the health world. An increasing number of medical APP have been 
designed in the last years, few directly managed from health care providers from public or private centers. The mHealth 
(Mobile Health) APP could led to a simpler, real-time connection between patients and health care professionals 
alongside with a bidirectional data flow and a steadily monitorization of patients’ evolution that could obtain a better 
preoperative follow-up without increasing the costs [24-26]. 
 
The present randomized clinical trial aims to prove the safety and efficacy of an interactive mobile application 
(Care4Today®) to obtain sufficient weight loss and empower patients with morbid obesity before being submitted to a 
gastric by-pass. 

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HYPOTHESIS: 
 
Main hypothesis: The preoperative use of the Care4Today (C4T) application in addition to standard protocol, in 
patients with a grade II-III obesity (BMI between 35 and 50 Kg/m2) achieves greater preoperative weight loss than 
standard protocols. 
 
 
Secondary Hypothesis: Use of the Care4Today (C4T) application in the preoperative setting achieves: 
 
- less intra- and post-operative complications at 30 and 90 days; 
 
- less technical complexity and duration of surgery; 
 
- better patients’ information and satisfaction; 
 
- better medical team coordination and satisfaction; 
 
- better weight loss outcomes at mid-term (1, 3 and 5 years). 
 
 
 
AIMS: 
 
Main goal: To compare patients’ preoperative weight loss after using the C4T APP in addition to standard protocol 
versus the standard preoperative protocol. 
 
Secondary goals: 
 
1. Compare patients’ information / satisfaction using the APP vs. standard protocol. 
2. Compare complications in the immediate postoperative period (30- and 90-days post-intervention) after the 
preoperative use of APP vs. standard protocol. 
3. Compare medical team coordination / satisfaction using the APP vs. standard protocol. 
4. Compare patients’ weight loss 3 months after surgery using the APP vs. standard protocol. 

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STUDY DESIGN: Randomized Clinical Trial to assess the safety and efficacy of a mobile application to monitor patients 
undergoing bariatric surgery. 
All patients will receive the standard preoperative protocol that consist in optimization of associated complications with 
an active management of obesity-related comorbidities, optimization of preoperative weight loss through a hypocaloric diet 
carried out during the 10-15 days prior to surgery and an informative and educational group session prior to surgery 
(EDUBAR). The C4T APP will be provided four months before surgery to all the patients randomized in the APP group. 
All the contents in the APP have been properly selected and modified by the multidisciplinary team (endocrinologist, 
pneumologist, anaesthesiologist, psychiatrist, nutritionist, nursery). Specifically, the APP contents include informative 
articles covering the nutritional, behavioral, and surgical fields, exercises, interactive charts, instructional videos, 
surgical animations, checklists, and frequently asked questions. The format of the APP will lead the patient through a virtual 
journey in the world of bariatric surgery, allowing to understand all the basic information about the preoperative period, the 
surgery and hospitalization and the postoperative follow-up. The use of the APP will influence preoperative weight loss 
through all the information provided, designed in an intuitive way so that the patient progresses in their level of knowledge 
and can assess through a checklist if they are doing the correct training. It will allow patients to set specific goals and 
assess their scope. Making patients aware of the importance of preoperative weight loss through training will be the key 
to obtaining correct adherence to the program and satisfactory preoperative weight loss. No patient data will be saved on 
the APP. 
To assess the impact of the APP, in addition to standard protocol, in the pre- and postoperative period, we will compare: 
 
- preoperative total weight loss percentage 
- level of patient information 
- level of patient satisfaction 
- level of medical team satisfaction 
- 30th and 90th days postoperative morbidity and mortality 
- percentage of weight loss 3 months after surgery 
 
 
CHRONOGRAM: 
 
OBSERVATION PERIOD 
 
Recruitment period of the study is expected to be 18 months, with additional 6 months to perform surgeries and follow- 
up. All information’s will be obtained using the application flow of data alongside with presential meeting with surgeons, 
endocrinologists, nutritionists. 
S. All the contents in the APP have been properly selected and modified by the multidisciplinary team. The day of 
surgery all the data about weight loss, patient and medical team satisfaction will be collected. Then, patients will be 
followed in observation of our standard postoperative protocol to assess the 30th and 90th postoperative morbidity and 
mortality alongside with weight loss evolution. The PhD student has been directly involved in the APP design and 
contents creation. He will perform the preoperative presential meeting to provide and explain the APP functioning to the 
patients in the APP group. Furthermore, he will collect the data on the day of surgery, during surgery and will be directly 
involved in postoperative follow-up of all patients. 

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STUDY POPULATION: 
 
Inclusion criteria: 
 
- 
Patients older than 18 and younger than 65 years who meet criteria to undergo bariatric 
surgery 
- 
BMI between 35 and 50 kg/m2 and indication of one-time surgery 
- 
Signing the informed consent of the study 
- 
Patient suitable for laparoscopic surgery 
- 
Patient who demonstrates accessibility to a smartphone and basic digital competence 
(Appendix 1). 
 
Exclusion criteria: 
 
- 
Previous bariatric surgery 
- 
Two-step surgery 
- 
Patient without resources to access the use of a Smartphone or without basic digital competence 
- 
Contraindication for surgery 
- 
Other surgical procedures associated with the same intervention 
Retirement criteria: 
- 
None 
 
 
 
EXPERIMENTAL TREATMENT: Use of a mobile application to accompany and empower patients in the preoperative 
period. 

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EVALUATION CRITERIA: 
 
Main criteria (for the main goal): Preoperative percentage of excess weight lost (%EWL), considering ideal BMI = 25, 
will be recorded. 
Following the follow-up protocol in General Surgery Outpatient Consultations, patients’ weight will be measured 4 
months before surgery and on the same day of surgery; then at 3, 6 and 12 months, and then every year up to 5 years 
of follow-up to calculate BMI and percentage of overweight lost, percentage of BMI lost, total weight and BMI lost. 
 
Secondary criteria (for secondary goals): 
 
1. 
Patients’ information and satisfaction using the APP vs. standard protocol will be evaluated using approved 
questionnaire (appendix 2, appendix 3); 
 
2. 
Morbidity and mortality: morbidity and mortality will be evaluated using the prospective database of the Bariatric 
Surgery Unit and the electronic medical record of each patient. All perioperative aspects related to the surgery 
will be reviewed. Complications will be recorded according to the Clavien-Dindo classification. 
 
3. 
Metabolic comorbidities: Comorbidities related to metabolic syndrome and morbid obesity will be recorded to study 
their evolution up to 5 years after the intervention: DM2, hypertension, DL and OSAS. 
 
4. 
Medical team coordination and satisfaction using the APP vs. standard protocol will be evaluated during 
multidisciplinary committee. 
 
5. 
Patients weight loss 3 months after surgery will be evaluated using the prospective database of the Bariatric 
Surgery Unit and the electronic medical record of each patient. 
 
6. 
Nutritional and metabolic deficiencies: The analytical studies performed each year on these patients will be 
evaluated to detect possible deficiencies: protein, iron, phosphocalcic, fat-soluble vitamins and trace elements. 
 
STUDY DURATION: 
 
The study is expected to begin in October 2022 
Patient recruitment period is expected from October 2022 to March 2024. 
Preoperative follow-up will be completed the day of surgery. 
Mid-term follow-up (2 years) will be completed in March 2026. 
Long-term follow-up (5 years) will be completed in March 2029. 
 
SAMPLE SIZE: 
 
The sample size was calculated in 142 patients divided into two groups of 71 patients each. It was calculated by 
comparing a hypothetical reduction of ≥ 5 kg in 55% of patients in the C4T group vs in 39% of patients in the control 
group [27] with a possible loss of 16% of patients, a confidence level of 95%, and statistical power of 80%. 

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STATISTICAL ANALYSIS: 
 
Continuous variables will be expressed as mean ± standard deviation or median (interquartile range) as appropriate. 
Differences between both techniques will be evaluated using a parametric test (χ2 for categoric variables and t test for 
continuous variables). We’ll use the IBM-SPSS Statistics Version 20 computer software to analyse all the statistics. A 
p value < 0.05 will be considered statistically significant. 
 
PERSONAL DATA PROTECTION / CONFIDENTIALITY / ETHICAL ASPECTS: 
 
This study may be developed in agreement with protocol and Good Clinical Practice (GCP) guidelines, like is described 
in Administration 91/507/EECC and Declaration of Helsinki, regarding the investigation with humans (“Ethical Principles 
for Medical Research Involving Human Subjects”). Researchers accept to follow these instructions and procedures 
described therein and therefore will comply with the principle of Good Clinical Practice on which it is based. 
 
Informed consent. 
 
A signed informed consent to participate in the study will be obtained (Appendix 4). Each patient will be informed about 
study nature and will receive an informative document about the study (Appendix 5). Patient will sign the informed 
consent for diagnostic and therapeutic procedures of the Hospital, as well as the specific consent to accept inclusion in the 
study. 
 
CONFIDENTIALITY 
 
Patients will be identified by a serial number and by the medical record number. Only study investigators will have 
access to this database. In any case, all the information (personal and clinical) collected from patients undergoing 
bariatric surgery will be treated in accordance with REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT 
AND OF THE COUNCIL of April 27, 2016 regarding the protection of persons regarding the processing of personal data 
and the free circulation of these data, as well as the rest of the laws and regulations in force and applicable, such as 
Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of the rights digital. 
 
ETHICAL ASPECTS 
 
Approved with Approval number: Ref PR150/22 by the Comité de Ética en Investigación Clínica, of University Hospital 
of Bellvitge,C/Feixa Llarga s/n 08907 L’Hospitalet de Llobregat, presidenciaceic@bellvitgehospital.cat, +932607389. 
 
BENEFITS OF RESEARCH 
 
To date, preoperative optimization has been considered as an important factor that influences the postoperative 
outcomes, but the evidence supporting this belief is mixed and most often retrospective. 
Our research will provide a clear, high-level evidence about the importance of preoperative weight loss in obese patients 
to improve short- and long-term outcomes. Furthermore, we aim to demonstrate that technology could be an essential 
mean to improve patients’ and medical team connections to obtain better treatment results. 

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Appendix 1: Questionnaire to select patients with enough digital competence: 
 
Technological Profile Labpsitec 
 
Please, mark the option that you think best suits you. 
When I handle new technologies, I consider myself to be a person with skill: 
 
 
SCARCE or NONE. Most of the time I have to ask someone 
more expert than me for help. 
 
SHORT. I defend myself, but with difficulty. 
 
NORMAL. I get to do the things I need to. 
 
ADVANCED. I consider that I know how to do more things than 
the rest of the people. 
 
EXPERT LEVEL. I have technical training. I am able to create 
content, program, etc. 

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Appendix 2: Questionnaire to assess patients’ information: 
 
PATIENT UNDERSTANDING QUESTIONNAIRE – VAMOS PROJECT 
 
1. Which of these foods is preferable in the preoperative diet? 
- 
Fried 
- 
Precooked 
- 
Grilled 
- 
Processed 
- 
In sauce 
 
2. Weight loss before surgery: 
- 
Reduces the risk of complications after surgery 
- 
Worsens scarring 
- 
Allows you to change the type of surgery 
- 
Increases risk of malnutrition 
- 
Is associated with more vitamin deficiencies 
3. Bariatric surgery allows: 
- 
Cure obesity 
- 
Reduce the volumes of the intakes without feeling so hungry 
- 
Give up diets and exercise 
- 
Eat without the need to split the diet 
- 
Eat without the need to choose healthy foods 
 
4. What is the name of the surgery that I am going to have? 
- 
Sleeve Gastrectomy  
- 
Gastroplasy 
- 
Gastric Bypass 
- 
Duodenal switch  
- 
Biliopancreatic diversión 
 
5. In the surgery that I am going to have: 
- 
Most of the stomach is removed, which is converted into a narrow tuve 
- 
A horizontal section of the stomach is made approximately through its middle 
- 
The small intestine is not modified and digestive secretions are not diverted 
- 
The volume of the stomach is reduced and the secretions of the liver and pancreas are diverted 
to the small intestine 
- 
Secretions from the liver and pancreas are passed through the stomach 
 
6. How many days will I be hospitalized if there are no complications? 
- 
1 
- 
2 
- 
3 
- 
4 
- 
5 
 
7. If there are no complications, what drugs will I NOT need after surgery? 
- 
Heparin 
- 
Mineral and vitamin supplements 
- 
Gastric protection (omeprazole)

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- 
Protein supplementation 
- 
Antibiotics 
 
8. After the surgery I will start with a diet: 
- 
Líquid 
- 
Shredded 
- 
Easy digestive 
- 
Solid 
- 
Soft 
 
9. The results of bariatric surgery are better if: 
- 
A vertical or sleeve gastrectomy type surgery is performed 
- 
A long-term low-calorie diet is adhered to 
- 
Rest is encouraged 
- 
Pecking is encouraged 
- 
Treatment with antiacids is completed 
 
10. I will have to take the vitamin and material supplementation: 
- 
One week 
- 
One month 
- 
Six months 
- 
One year 
- 
Indefinitely 

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Appendix 3: Questionnaire to assess patients’ satisfaction: 
 
PATIENT SATISFACTION QUESTIONNAIRE – VAMOS PROJECT 
 
      Scarce           Poor          Good     Very good   Excellent  
1. Kindness/Courtesy of the medical team……………………………….............. 
O 
O 
O 
O 
O 
2. Explanations of the medical team about your pathology…………….………... 
O 
O 
O 
O 
O 
3. Interest that the team has shown in clearing up your doubts and concerns……. 
O 
O 
O 
O 
O 
4. Willingness of the medical team to include you in treatment decisions ..…….. 
O 
O 
O 
O 
O 
5. Information provided by the team on the type of medication…………………. 
O 
O 
O 
O 
O 
6. Instructions provided by the medical team on follow-up……………………… 
O 
O 
O 
O 
O 
7. Comprehensibility of the language of the information received………………. 
O 
O 
O 
O 
O 
8. Time that the medical team has dedicated to you……………….…………….. 
O 
O 
O 
O 
O 
9. Your confidence in this medical team………………………………………… 
O 
O 
O 
O 
O 
10. Probability that you recommend this medical team to other patients…..……. 
O 
O 
O 
O 
O 

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Appendix 4: Informed consent 
 
PROSPECTIVE RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF A MOBILE 
APPLICATION FOR THE ACCOMPANIMENT OF PATIENTS UNDERGOING BARIATRIC 
SURGERY – VAMOS PROJECT 
(Virtual Accompaniment for Morbid Obesity Surgery). 
Informed consent 
(In accordance with Law 41/2002, of November 14, Basic regulation of patient autonomy and rights and obligations in terms of 
 information and clinical documentation and the Oviedo Convention 4/4/1997) 
 
I, Mr./Ms..…………………………………………………………………. 
(Name and surname of the patient or legal representative) 
 
As,  ........................................................................... , I declare that: 
(Relationship with patient) 
 
 
- I have received and carefully read the information sheet of the study. 
- I have been able to ask the appropriate questions about the study. 
- I have received sufficient information about the study and I have understood it. 
- I authorize access to my clinical history by the research team, for research purposes. 
 
I have been informed by Dr.……………………………………………. 
(Name and nº of the researcher) 
 
 
I understand that my participation is voluntary and disinterested. 
 
I understand that I may refuse to participate in the study without affecting the assistance I receive 
 
Therefore, I freely give my consent to participate in the study.. 
 
 
 
Patient signatura (or legal representative) 
Physician signature 
 
 
 
 
 
 
L´Hospitalet de Llobregat 

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Appendix 5: Informative document for the patient 
 
PROSPECTIVE RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF A MOBILE 
APPLICATION FOR THE ACCOMPANIMENT OF PATIENTS UNDERGOING BARIATRIC 
SURGERY – VAMOS PROJECT 
(Virtual Accompaniment for Morbid Obesity Surgery). 
 
Patient information sheet 
(In accordance with Law 14/2007 on biomedical research and the Declaration of Helsinki revision of 
Fortaleza, 2013) 
 
 
You are going to undergo elective laparoscopic surgery to treat your morbid 
obesity and the diseases derived from it. In his case, after analyzing his clinical 
characteristics, the possibility of carrying out a preoperative follow-up by using a mobile 
application to monitor pre-surgical optimization has been indicated. 
 
The treatment of obesity is multidisciplinary, from changes in lifestyle and diet 
to surgery. Although surgery is the most effective treatment, to obtain the beneficial effects, 
the commitment of the patient is essential. Preoperative optimization, with a correct 
lifestyle and a balanced diet in the months before and after surgery reduces the risk of intra- 
and postoperative complications while improving the effectiveness of surgery. Correct 
information increases the level of patient satisfaction, reduces the level of anxiety and 
improves adherence to the preoperative protocol. In this context, mobile technology, 
already definitively accepted and involved in the daily life of each person through 
Smartphones, provides a unique tool that allows direct communication, establishing a 
continuous exchange of information, the resolution of doubts, the assessment of the degree 
of patient satisfaction, and also educate and monitor patients in real time without leading 
to a disproportionate increase in costs. At the Bellvitge University Hospital (HUB) we are 
carrying out a research study on the impact of the use of a mobile application to accompany 
patients undergoing bariatric surgery with respect to standard preoperative follow-up. 
(Clinical trial authorized by the HUB Clinical Research Ethics Committee). 
 
As in any abdominal surgery, complications can occur: hemorrhage, wound 
infection, intestinal fistula, abdominal pain, vomiting, intolerance to oral intake, etc. Like 
any patient undergoing this type of intervention, you will have all the technical and human 
resources available at our Center to try to solve any complications that may arise. 
 
If you agree to participate in this study, you will be randomly assigned to one 
of two groups: Standard Preoperative Protocol or Standard Preoperative Protocol + Mobile 
App. All aspects of the intervention you will undergo (laparoscopic approach, preparation 
and postoperative management) will not be affected by this study or the group to which 
you will be assigned. 
 
Currently there are no scientific data indicating the superiority of one 
preoperative protocol over another. The objective of the study is to analyze whether there 
are significant differences between a standard preoperative follow-up or with a mobile 
application. With the 
  
With the results obtained, we hope to be able to employ the most beneficial 
preoperative protocol for future patients who, like you, will undergo elective bariatric 
surgery. 

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Your participation in this study is completely voluntary and disinterested. 
 
Your personal data will be treated confidentially and will only be used by our 
team for medical research purposes. Only the part of your clinical history whose data is 
relevant for the study will be accessed (in accordance with the provisions of Organic Law 
3/2018 on Data Protection and Guarantee of Digital Rights, and EU Regulation 2016/679 
General of Data Protection). Your data will be totally dissociated from the data that allows 
your identification. To maintain your anonymity, you will be assigned a code number. Only 
the research medical team will have access to your data, and, if required, also the Research 
Ethics Committee and the Health Authorities. The study data is expected to be kept for a 
period of 20 years. Regarding the data collected for the purpose of the study, you have the 
right to access, rectify, cancel, oppose, limit the processing of data that is incorrect, request 
a copy or transfer it to a third party for processing (portability). To exercise your rights, 
you may contact the principal investigator (josorio@bellvitgehospital.cat) or the 
institution's Data Protection Officer (dpd@ticsalutsocial.cat). In case of international 
transfer of data, your confidentiality would always be protected by maintaining your 
anonymity and identification by means of a numerical code. Finally, you may file a claim 
with the Catalan Data Protection Authority if you consider that your data protection rights 
have been violated. 
 
Of course, if you decide not to participate in the study, your medical care will 
not be affected in any way. 
 
The research team will be willing to clarify all the questions that you wish at 
any time and phase of the study. 
 
If you agree in participating the study, please sign the attached consent form.