Usability Study of IeHS in Indonesia

Study Overview
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Brief Summary
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Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health. The proposed model of a secured mobile health application may promote patient's self-management and enhances adherence in chronic therapy exactly as it is easy-to-use, reducing patient's burden in accessing medication information and instructions, and providing the opportunity for direct communications with health providers in charge for each patient with access to mobile technologies. Consequently, medication errors and unnecessary paperwork in the healthcare system will be avoided as well as giving more time for healthcare providers to pay greater attention to delivering medical care effectively and efficiently.

Detailed Description
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Tuberculosis (TB) remains the world's leading infectious threat as it kills more than 1 million people worldwide every year, with most of them in low and middle-income countries1. Several medical conditions impair innate and acquired immunity and favor the occurrence of TB disease in individuals who are latently infected2,3. People living with HIV (PLHIV) have a higher risk to be infected by TB as their immunocompromised status than that of HIV negative and as the cause of death in a quarter of PLHIV/AIDS4,5. Malnutrition and protein imbalance, i.e., in diabetes, can also impair the immune system and increase the risk of TB and TB-related death2,6. The daunting rise in cases of TB, HIV, and diabetes poses further major threats to public health worldwide. They were ranked as top diseases to cause high mortality in South East Asia (SEA), which accounted for deaths for 1.6 million, 940,000, and 30.3 million in 2017, respectively. The association between communicable and non-communicable diseases has been known for the past years, yet the optimization of the therapy remains scarce. Therefore, sustained and well-maintained healthcare approaches to make sure patients stay adherent and compliant to medication therapy are needed and remain of utmost importance. Beyond the deadly combinations of the diseases and the improvement in disease treatments, an issue on the communication among the involved parties (e.g., physicians, pharmacists, and patients) needs to be marked crucial. Physicians and pharmacists have each specific role in the healthcare system, and the positive impacts of their collaboration have been established in several studies. The collaborative relationship between physicians and pharmacists accelerates the improvement of patient's therapy and thus provides a better quality of care. However, barriers in communications can still be noticed in the healthcare setting, especially in countries where the existence of pharmacists is limited. Time constraints and ineffective communication would be the significant points needing to be considered. This situation should be avoided as poor communication among them may lead to several negative impacts such as prescribing errors, treatment delay, unidentified adverse events, and even death7,8. Over the last decades, mobile phone technology as a part of information and communication technology (ICT) has considerably been used in supporting diseases' treatments as a modality to improve medical care efficiency and adherence and to provide continuously updated clinical evidence. The ubiquity of mobile technologies, such as smartphones, enhances the ability to assess and improve general health. It has therefore created salient opportunities for the treatment and evaluation of a large number of common, intractable, expensive medical conditions. Such technologies in the healthcare setting can easily be accessed and are likely cost-effective, given its modest costs9. For example, a cost analysis of the use of mobile phones in Kenya revealed that text-message intervention in HIV treatment was cost-effective on the basic travel of expenses alone10. Conversely, concerns also have been expressed regarding the safety, confidentiality, quality of its content, and regulations on the use of mobile health applications11. Much attention has been directed at the use of ICT in Indonesia due to the nations' unique geographic and socioeconomic characteristics. Indonesia is an archipelago country with 270 million population (population density of 140.08 individuals per square kilometer of land area)12. Being ranked 4th of countries with the highest population and the seventh largest country in terms of combined sea and land area worldwide, Indonesia is then believed to be one of the fastest growing markets for mobile phones in the SEA with 438.6 million mobile users. Having to mentioned the explanations above, the investigators, therefore, will research an easy-to-use - yet confidential and comprehensive - web-based healthcare application to be applied to high-risk patients; i.e., TB and HIV. By applying this web-based app to the specific population, the investigators hope to enhance the quality of care as well as the quality of life of such patients. The investigators will report on the findings and then discuss the future use of the web-based app. With the complexity of drugs treatments in HIV and TB, treatment using mobile technologies is increasingly valued and becoming a trend over the past years. Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health. The proposed model of a secured mobile health application may promote patient's self-management and enhances adherence in chronic therapy exactly as it is easy-to-use, reducing patient's burden in accessing medication information and instructions, and providing the opportunity for direct communications with health providers in charge for each patient with access to mobile technologies. Consequently, medication errors and unnecessary paperwork in the healthcare system will be avoided as well as giving more time for healthcare providers to pay greater attention to delivering medical care effectively and efficiently. The objective of the study is to conduct a usability testing of the web-based app in high-risk participants (HIV and TB patients). Usability testing will be conducted using a quantitative approach to evaluate the effectiveness, efficiency, and user satisfaction. After performing the usability testing of the web-based app on selected participants, investigators perform an in-depth interview to explore further problems, barriers, feedbacks, and potential advantages of the use of IeHS web-based app.

Official Title
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The Usability Testing of the IeHS (Integrated E-healthcare Services) Web-based Application in the Therapy Management of HIV and Tuberculosis in Indonesia: a Concurrent Nested Study Design

Conditions
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Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations, Mobile Phone Use, Adult

Intervention / Treatment
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* Other: Integrated e-healthcare services (IeHS) web-based app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 18 years old or more; Acting as one of the following users: pulmonologist, internist, GP, pharmacists, and a patient who suffers from TB and/or HIV; In case of a patient user: on drug treatment; Use a smartphone and know how to use it; Familiar with technology, particularly ICT; Understand basic english; Able to speak and communicate in Bahasa Indonesia; Willing to participate and sign informed consent. Exclusion Criteria: A severe clinical condition that might impair the hearing or the seeing; Unwillingness to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Integrated e-healthcare services (IeHS) web-based app<br>This usability study is conducted under 3 steps: IeHS simulation, user experience survey using SUS questionnaire, and qualitative study through the in-depth interview. | Other: Integrated e-healthcare services (IeHS) web-based app<br>* Each participant is asked to complete study tasks using the IeHS web-based app as a part of IeHS simulation. This activity is followed by user experience survey, and an in-depth interview to explore user satisfaction on the IeHS web-based app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tasks completion success | Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation | during the simulation for each participant in 3 months of study period | 
| Numbers of tasks errors | Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation | during the simulation for each participant in 3 months of study period | 
| Average time to complete each task | Efficiency is defined as level of efforts use by the study participant to complete the web-app simulation each task. | during the simulation for each participant in 3 months of study period | 
| system usability scale (SUS) score | IeHS satisfaction is defined through the SUS questionnaire which allows measurements of overall usability, allowing comparisons across a range of contexts and systems. SUS score is ranged from 0 (worst) to 100 (perfect). | after half-an-hour of the web-app simulation during 3 months of study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant experience using the IeHS web-based app | Participants/users are asked about their experiences and perceptions after the simulation regarding to the effectiveness, efficiency, satisfaction, obstacles, and IeHS potential use. These arguments will be collected qualitatively through in-depth interview. | half an hour after web-based app simulation during 3 months of study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical care, HIV, TB, Internet, Surveys and questionnaires, Humans, Pharmacovigilance