JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Protocol The Notijoves Project: Protocol for a Randomized Controlled Trial About New Communication Technologies and Gamification to Promote Partner Notification of Sexually Transmitted Infections Among Young People Dolors Carnicer-Pont1, MD, MPH, PhD; Eva Loureiro-Varela2, MSc; Josep Mª Manresa3,4, MD, BScB; Montse Martinez5, Midwife, RN; Àngels Avecilla6, MD; Laura Montero-Pons7, Midwife, RN; Gemma Falguera-Puig8, PhD, Midwife, RN‡ 1 Cancer Prevention and Control Programme, Catalan Institute of Oncology, Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain 2 Informatics Department, Catalan Institute of Oncology, Hospital Duran i Reynals, L'Hospitalet de Llobregat, Spain 3 Research Suport Unit, Metropolitana Nord, Primary Health Research Institute, Barcelona, Spain, Spain 4 Nursing Department, Authonomous University of Barcelona, Cerdanyola del Vallès, Spain 5 ASSIR Cerdanyola del Vallès, Metropolitana Nord, Institut Català de la Salut, Barcelona, Spain 6 Badalona Assistential Services, Badalona, Spain 7 ASSIR Santa Coloma de Gramanet, Metropolitana Nord, Institut Català de la Salut, Barcelona, Spain 8 ASSIR Sabadell, Metropolitana, Metropolitana Nord, Institut Català de la Salut, Barcelona, Spain, Spain ‡ Sexual and Reproductive Health Consolidated Emerging Group Corresponding Author: Dolors Carnicer-Pont, MD, MPH, PhD Cancer Prevention and Control Programme Catalan Institute of Oncology Hospital Duran i Reynals 199-203, Gran Via de L'Hospitalet, Avenue L'Hospitalet de Llobregat, 08908 Spain Phone: 34 93 260 73 57 ext 7339 Email: dcarnicer@iconcologia.net Abstract Background: An increase in sexually transmitted infections (STIs) as well as an increase in the use of new information and communication technologies among young people in Catalonia is the inspiration behind the idea of designing a smartphone app to promote partner notification of STIs. Objective: The main objective of this study is to design a Web-based tool adapted to smartphones for partner notification of STIs among youth who are 16 to 24 years old. Additionally, the objective is to evaluate the Web-based tool’s role in increasing the patient referral partner notification. Methods: This is a multicenter randomized controlled trial with a proportional stratification of the sample by center and random allocation of participants to the 3 arms of the study (simple Web-based intervention, game Web-based intervention, and control). This study is being conducted by midwives, gynecologists, and physicians in the sexual and reproductive areas of the primary health care centers. Results: The primary outcome measure is the number and proportion of partner notifications. Additional outcome measures are the yield of early diagnosis and treatment of those exposed and infected, acceptability, barriers, and preferences for partner notification. Expected results include an increase in the yield of partner notification, early diagnosis and treatment among youth using Web-based interventions compared with those receiving the traditional advice to notify, and a description of sexual networks among those participating in the study. Conclusions: The Notijoves is expected to have a sustainable positive impact in the partner notification practice among youth and contribute to increasing the awareness of STI prevention. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 1 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al International Registered Report Identifier (IRRID): DERR1-10.2196/12896 (JMIR Res Protoc 2019;8(6):e12896) doi: 10.2196/12896 KEYWORDS mobile apps; sexually transmitted infections; partner notification; youth; games, experimental; game theory; randomized controlled trial This study also includes the social network analysis that allows Introduction for a deep study of the relationships among young people. It is Background and Study Rationale based on the evidence that transmission of sexual infections in a social group is determined by the existence of central members Prevalence of sexually transmitted infections (STIs) among within the social structure [13]. Therefore, we aim to conduct young people has increased over the years. In Catalonia, a randomized controlled trial to assess the effectiveness of prevalence of Chlamydia trachomatis among those below 25 partner notification through the use of new information and years increased from 5.8% in 2008 to 8.5% in 2013 [1]. The communication technologies (ICTs). Our hypothesis is that the most affected age group is the 16 to 18 years old. percentage of partners informed by their index cases will be The main rule to control communicable diseases is guaranteeing higher when the index cases can use new technologies an early detection of the infected to treat them and alert the (personally or anonymously) compared with the use of paper exposed [2]. Therefore, sexual partner notification is crucial to notification card to do a face-to-face partner notification, without reach awareness of the exposed and facilitate testing for potential any specific guidance. diagnosis. Scientific evidence highlights the need to improve Development of an App to Promote Patient Referral partner notification and early testing [3-5], and in the case of Partner Notification Chlamydia trachomatis, partner notification is proved to be more cost effective than systematic screening [6,7]. Partner According to the Report of the Spanish Digital Society, 2017, notification is recognized to be crucial for reducing transmission 86% of the youngsters aged 15 to 24 years own a smartphone, and preventing reinfection at an individual level [3]. and this has become their main means of communication. It is expected that in 2018, 50% of these youngsters will exclusively In our country, as well as in most of the other European use smartphones to be on the Web [14]. In addition, these countries, the most frequently used models of partner youngsters are heavy users of smartphone apps. Making notification are the ones done by the patient itself (patient available a responsive smartphone app that helps to do partner referral), and the one done by the health professional after notification, either personally or anonymously, may increase obtaining the patient’s approval (provider referral) [8]. partner notification practice. New and innovative ways of An internet-based system of partner notification allows the addressing partner notification in a sustainable way that can anonymous practice through a Web-based notification, an email, benefit youngsters and reduce transmission are a high priority. or short messaging system. This tool may help in getting in That is why we proposed the development of a smartphone app touch with previous sexual partners with whom there is no in Spanish and in Catalan (see Figure 1 for app icon in Spanish). interest to revisit in person. Experts in gamification and Web app contributed to its development, drawing on the gamification-information- In addition, the introduction of a gamified approach of partner motivation-behavioral skills approach to behavioral change notification among youngsters is an innovative way to involve [15]. those who otherwise would not be interested in notifying. By discovering through gamification the main aspects of the STI A total of 3 workshops with youngsters of different social levels that the youngsters were diagnosed with and the importance of were conducted by a psychologist, anthropologists, and nurses notifying partners for the prevention of further transmission, to identify the best way to design the game. the youngsters are more likely to notify their partners about a The app contains different story games that are sensitive to potential infection, and they are more likely to advise them to sexual orientation of youngsters, adapted information to the STI get tested for the potential infection. that was diagnosed to the patient, and choice of different Provided that youngsters are prone to using new technologies methods to do partner notification (short message service, email, and video games and that previous studies prove the utility of WhatsApp, or face to face), either anonymously or by gamification as an important tool to promote behavior changes identifying himself or herself. At the end of the game, the [9-12], we propose to include this gamification as a third arm youngsters will have learned preventive features of the infection, of the trial. and they should be motivated to inform all sexual partners exposed to the STI; in addition, they will choose a method to send them the message or inform them personally. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 2 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Figure 1. App icon “in Spanish”. Ethical and Research Governance Approval Aims and Objectives This trial was approved by the Ethics Committee of the Institute The aim of this study is to describe the protocol for the of Research in Primary Care of Catalonia Institut Universitari randomized controlled trial of the Notijoves Web-based tool, d’Investigació en Atenció Primària Jordi Gol and given funding adapted to smartphones for partner notification of STIs among through the competitive call: Health Research and Innovation youngsters aged 16 to 24 years. Strategic Plan 2016-2020 of the Catalan Government The first objective of the study is to design the tool and evaluate (ID:SLT002/16/00197). its role in increasing partner notification done by the patient (patient referral partner notification) for all eligible sexual Participants partners. This trial is being conducted in 7 public-based primary health care centers for sexual and reproductive health of Catalonia in The specific objectives are the following: the cities of Mataró, Badalona, Santa. Coloma de Gramanet, • Describe sociodemographic characteristics of index cases Granollers, Mollet, Cerdanyola-Ripollet, and Sabadell. and consecutive sexual partners Participants to the study are being recruited in each of the • Describe coinfections within the group primary health care centers according to the following inclusion • Describe acceptability, barriers, and preferences for criteria: Young people 16 to 24 years old, diagnosed with at executing partner notification using ICTs least 1 of the curable STIs (syphilis, gonococcus, or chlamydia). • Evaluate the utility to apply the game theory (gamification Partners who have had sexual contact within the previous 6 to promote behavior change) in the design of a Web app months since the diagnosis of index case. for partner notification of STIs Exclusion criteria are the following: diagnosis of other STIs • Evaluate the yield of ICTs for partner notification of STIs (trichomonas, HIV, Hepatitis C, and Hepatitis B), which, among sexual partners although partner notification is advisable, will not be included • Assess the impact of ICTs in primary transmission of STIs to prevent complexity in the study. Under the diagnosis of 1 of • Describe the characteristics of the social and sexual network these STIs, health professionals will perform according to the among youngsters current clinical guidelines. Methods Study Period The study will be conducted within a 3-year period. A total of Design 1 year to prepare the Web app, 18 months for the field work, This is an unblinded 3-armed randomized controlled trial, and 6 months for the evaluation and dissemination of results. assigning patients to each arm of the study through the proportionally stratified sample of patients by health center, Groups of the Study which will test the primary hypothesis that a greater proportion Control Group of partners will be informed about their exposure to STIs Those receiving the recommendation to inform their partners (syphilis, chlamydia, or gonococcus) in the intervention groups about exposure to STIs by the standard procedure currently compared with the control group. We will randomize 416 young available in the Catalan guidelines, use of a Partner notification and recently diagnosed index cases in 1 of the 7 centers of the paper card. study. The researcher responsible for analyzing the data will be blind to group allocation. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 3 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Game Intervention Group study. He also prints the informed consent to be signed by the Those advised to enter the Notijoves Web app with a code and patient and explains all the procedures to him/her, according to follow the steps of the game to finally choose among different the arm assigned (control, direct Web app, and game Web app). ways to notify their partners. A copy of the Informed consent is given to the patient, and the original is kept under the custody of the health professional in Web App Direct Intervention Group the participating center. Those advised to enter the Notijoves Web app with a code and Participation Procedure directly choose among different ways to notify their partners. All the candidates who accept to participate in the study are Main Outcome Variable given information about the study, both verbally and by The main outcome variable of the study is the percentage of receiving an Information sheet. The candidates refusing partners informed of their exposure to a STI from their index participation are also asked to complete a quick survey (2 cases, according to the assigned study group. questions) to provide reasons for not participating. (see Figure 2) Sample Size Control Group Young population accessing all centers of study within a year is around 400. They have been randomly distributed in 3 arms, The control group receives usual partner notification advice, according to the Bonferroni correction, to allow multiple and the health professional prints as many partner notification comparisons of outcomes with a significance level of P=.016. paper cards as the patient index case mentions to be able to The trial is expected to have 10% of withdrawals after provide partner notification paper cards to exposed partners. recruitment within the intervention groups and 20% of Therefore, exposed partners are expected to receive a partner withdrawals after recruitment within the control group. notification paper card and a letter that are to be given to their Therefore, to have at least 120 participants in each 1 of the health professional. The letter informs of the potential diagnosis groups, 133 are recruited in each 1 of the intervention groups and advised treatment. The card has information of the STI and and 150 are recruited in the control group. The random list ratio the list of Sexual and Reproductive Health Centers and primary is 1:1:1.28. To achieve this sample, participant recruitment is health care centers for sexual and reproductive health, where allowed for a period ranging from 13 to 18 months. the recipient of the notification can go for diagnosis and potential treatment. Randomization and Informed Consent Procedure The random code given to the index case patient appears in the The sample is proportionally being assigned to each of the 7 informed consent and in a short paper questionnaire (12 centers, according to their regular activity (see Table 1). questions). Each 1 of the partner notification paper cards has a The health professional proposes that the young patient index code in line with the study arm of the index case. This means case should participate in the study, and once verbal acceptance that partners receiving a partner notification paper card from is obtained, he gets into the Web app (see Figure 1) to obtain a an index case assigned to the control arm are kept in the control random code that assigns the patient to 1 of the 3 arms of the arm themselves. Table 1. Sample size distribution for each primary health care center for sexual and reproductive health. Location of health care centresa Controlb N1 Intervention gamec N2 Intervention Webd N3 Total N Badalona 30 26 26 82 Sabadell 27 24 24 76 Granollers 27 24 24 74 Mollet 20 18 18 57 Mataró 20 17 17 55 Santa Coloma 14 13 13 40 Cerdanyola 12 11 11 34 Total 150 133 133 416 a Primary Health Care Centres for Sexual and Reproductive Health. b Control group. c Game intervention group. d Web app direct intervention group. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 4 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Figure 2. Algorithm of participation.STI: sexually transmitted infection. The electronic partner notification card has the following: (1) Web App Game Intervention Group a code automatically assigned by the electronic system that is Individuals assigned to this group receive an Information sheet concordant with the arm where the index case patient entered explaining the objectives and procedures of the study. After the study, (2) the informative message advising the partner to providing a signature of their informed consent, they receive a visit a health center for diagnosis and potential treatment, and paper copy of this informed consent that has a specific code (3) a link to a list of health centers of the study and the Web through which they enter the game by connecting to the app address, where the partner could go and where the informed Notijoves Web address. A paper card with the “Notijoves” Web partner could enter and participate in the study by introducing address is given to the patients. Once they enter the Web app, the code. Along with the notification card, the partner receives they are asked to feed the given code into the field of Young an electronic letter to be given to the health professional for PANDORA screen. him to be aware of the STI diagnosed to the sender of this By entering the code, they start playing the game, and they are notification and the advised treatment. directed through different screens and situations. A Web-based Web App Direct Notification Intervention Group questionnaire is inserted in the game. At the end of the game, Individuals assigned to this group receive an Information sheet they are also asked to respond to a satisfaction questionnaire. explaining the objectives and procedures of the study. After The game is expected to motivate the youngster to notify providing a signature of their informed consent, they receive a partners of their exposure to an STI. While playing the game, paper copy of this informed consent that has a specific code the youngsters are asked to answer questions related to the through which they enter the Notijoves Web address. A paper clinical symptoms, prevention, and control of their recently card with the Notijoves Web address is given to the patients. diagnosed STI. Like this, they learn by playing. Another feature Once they enter the Web app, they are asked to feed the given of the Web app is the link to advisory videos on how to approach code into the field of Young PANDORA screen (see Figure 3). the face-to-face notification of exposure to an STI. Finally, the By entering the code, they are directed to a Web-based game ends with a screen, where the youngsters can choose from questionnaire and are offered an option to choose from among among the different electronic tools to notify (short message the different electronic tools (short message service, email, or service, email, or WhatsApp) either anonymously or by WhatsApp) to notify either anonymously or by identifying identifying themselves. themselves. Finally, they are also asked to respond to a satisfaction questionnaire. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 5 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Figure 3. Entrance to game “in Catalan”. 4. Participants assigned to 1 of the intervention groups who What Happens to the Partners Receiving the finalized the experience of partner notification after using Notification Card? the Web app Partners visiting participating centers are easily linked to the For each 1 of the situations, there is a specific questionnaire: study by their code, and they are also offered participation to the study. Once accepted, they also sign the informed consent, 1. The questionnaire given to index cases collects data on the and they are asked to respond to a recipients’ questionnaire. recruiting health care center, date of interview, date of birth, After receiving the test results, if they are infected, they initiate sex (boy, girl, transgender born as man, and transgender the same procedure as an index case, with their given code, in born as woman), country of birth, mother’s country of birth, concordance with the branch of the study that their index case education (without studies, primary studies, secondary was assigned. If they are not infected, the health professional studies, and university), with whom they have sex (boys, registers results linked to the receptors questionnaire. girls, or indistinctly boys or girls), number of sexual partners 6 months before the diagnosis, whether they look at There may be partners visiting participating centers but not webpages to obtain information about STIs (yes, no), bringing the letter for the health professional and not having whether they look for partners on the Web (yes, no), the code. These partners cannot be linked to any partner currently diagnosed with STI, positioning toward partner notification card, and therefore they are lost to follow-up for notification (will inform all partners, only some, none, and the system. Nevertheless, if they turn out to be infected, they do not know), and reasons for not notifying. are recruited as new index cases, with a new randomly assigned 2. The questionnaire given to recipients of a partner code. Moreover, those partners visiting a center out of the study notification card collects the same data as above and area are lost to follow-up for the study. substitutes the last 3 questions with to which STI have you Data Collection been exposed? How did you get to know your exposure The Web app has 2 entries: the entry of health professional and (face to face, partner notification card, WhatsApp, short the entry of the youngster. message service, email, and other)? Did you receive the notification anonymously (yes, no)? The health professional entering the Web system activates the 3. Those not wanting to participate are asked about their random assignment of the code to 1 of the 3 arms of the study reasons in an open question. They are also recorded as index and registers the information on the diagnosed STI. case or recipient of a notification. 4. The opinion or satisfaction questionnaire collects data on The involvement of the youngsters with the study gives rise to different situations among candidates: whether the Web app helped its users to solve doubts related to STIs (not at all, a few, normal, quite a lot, and a lot), 1. The index case wanting to participate usefulness of the Web app to notify partners (not at all, a 2. The recipient of the notification wanting to participate few, normal, quite a lot, and a lot), use of the anonymous 3. The index case or the recipient not wanting to participate option to notify (yes, no), easiness to choose from among https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 6 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al the options to notify (yes, no, and if not, why not?), wish participate in the study. They were assigned randomly to control to recommend the Web app to friends (yes, no, and if not, group (n=15), game intervention group (n=9), and Web direct why not?), and how can we improve the Web app? (open intervention group (n=8). question) The project is currently recruiting with a rate of approximately Data Analysis 6 recruitments per month. Recruitment is slower than expected. Descriptive analysis of index cases visiting health centers will Mainly because of the difficulties in the implementation of the be baselined to further assess differences in yield by groups. Web app. Our confidence is that within the last 6 months of the Chi-square test and Student t test for categorical and continuous field study, recruitment pace will be doubled, and the expected variables will be used to assess differences in baseline sample size will be achieved. To improve recruitment, since characteristics among groups. Regression analysis and adjusting September 2018, we have allocated 3 more professionals to the for confounding variables will be used to evaluate the primary task. outcome and relative risk, and its 95% CIs will be calculated. Significance will be set at .05. The multiple imputation method Discussion will be used to generate possible values for missing values. This Summary is considered the gold standard for dealing with missing values. Data will be analyzed in Stata v12 (StataCorp LLC). During the trial period, the Web app is only available to research participants; therefore, source coding and App content have The methodology of analysis of the social and sexual networks been preserved. will be used from an egocentric perspective. Structural measures of the network will be calculated, such as the size of the Limitations network, number of direct links, density, the geodesic average First, the study relies on an assumed independence of the groups. distance, diameter of ego’s network, and measures of centrality, This means that young participants randomly assigned to 1 of such as the degree of intermediation of a contact or index case. the intervention groups will not share information with those Furthermore, we will compare social network, density, and falling in the control group. However, it can happen that some structure. Network measurements will be done using the R controls have friends assigned to the game or Web app directly statistical package. and that they visit it with them. This can generate a classification Confidentiality, Storage, and Archiving bias, underestimating the real effect of the intervention. Second, information bias to assess primary transmission can occur when Data will be archived in a safe environment, according to the not all expected partners to be notified are the ones who visit European Data protection law. health centers for testing. Third, those partners receiving a Ethical Aspects notification but visiting a health center out of the study area will be lost to follow-up if they are assigned to the control group. The investigators are committed to respect the prevailing norms This will generate a participation bias, overestimating the partner of Good Clinical Practice, the requisites of the Declaration of notification yield of the other arms of the study. Fourth, a Helsinki, and the clauses of general and particular ethical malicious use of the Web app could occur, when anonymous conditions related to the right to privacy, anonymity, and partner notification is sent by some youngsters to other confidentiality. Neither the first name nor surname or any other youngsters who were not even exposed. This may generate type of data indicating the identification of the young population overestimation of the partner notification yield. Finally, we will be registered. Therefore, identification will be made by cannot fully ascertain the network across experimental alphanumeric codes. Youngsters participating in the study will conditions because of the anonymous condition of our sign an Informed Consent by paper, and when they are enrolled experiment. It may happen, although very rarely, that partners through the Web, they will confirm acceptance to participate receive a notification from 2 index cases assigned to different by clicking on the confirmatory cell. arms of the trial. In that case, the system assumes that the first notification received by the youngster is the one that will be Results followed-up and the one that will contribute to network analysis. The Web app was available to the health professional to initiate Conclusions recruitment by early April 2018. From April 1 to May 30, we Few studies have examined the yield of partner notification expected to recruit 83 index cases, but difficulties on among young people, especially by the use of Web apps. The accreditation of new health professionals and on entry to the Notijoves smartphone app is an intervention that, if shown to study environment in the Web prevented recruitment. In early be effective, may be implemented for all of Catalonia. June 2018, there were 32 young people who accepted to Acknowledgments The authors wish to thank Anna Sort for her work in creating the app, as well as providing outstanding expertise in gamification development, and the authors wish to thank Angels Medrano for her design of the orientating videos to guide partner notification. This study is supported by a project grant from Health Research and Innovation Strategic Plan (PERIS) 2016-2020, approved by the Catalan Government (SLT002/16/00197). https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 7 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Conflicts of Interest None declared. References 1. Department of Health. Catalonia. Spain. URL: http://www.ceeiscat.cat/documents/sives2015_CAT.pdf [accessed 2018-11-14] [WebCite Cache ID 73vS0Q6LT] 2. Heymann DL. Control of communicable diseases manual. 20th edition. Washington DC: American Public Health Association Press; 2015. 3. European Centre for Diseases Prevention and Control. 2013. 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Playbenefit gamification URL: https://www.playbenefit.com/es [accessed 2019-05-08] [WebCite Cache ID 78DPmm6Cr] Abbreviations ICT: information and communication technology STI: sexually transmitted infection https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 8 (page number not for citation purposes) XSL• FO RenderX JMIR RESEARCH PROTOCOLS Carnicer-Pont et al Edited by G Eysenbach; submitted 23.11.18; peer-reviewed by M Hogben, KA Nguyen; comments to author 31.03.19; revised version received 08.04.19; accepted 08.04.19; published 26.05.19 Please cite as: Carnicer-Pont D, Loureiro-Varela E, Manresa JM, Martinez M, Avecilla À, Montero-Pons L, Falguera-Puig G The Notijoves Project: Protocol for a Randomized Controlled Trial About New Communication Technologies and Gamification to Promote Partner Notification of Sexually Transmitted Infections Among Young People JMIR Res Protoc 2019;8(6):e12896 URL: https://www.researchprotocols.org/2019/6/e12896/ doi: 10.2196/12896 PMID: 31199306 ©Dolors Carnicer-Pont, Eva Loureiro-Varela, Josep Mª Manresa, Montse Martinez, Àngels Avecilla, Laura Montero-Pons, Gemma Falguera-Puig. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.05.2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. https://www.researchprotocols.org/2019/6/e12896/ JMIR Res Protoc 2019 | vol. 8 | iss. 6 | e12896 | p. 9 (page number not for citation purposes) XSL• FO RenderX