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Human Immunodeficiency VirusNCT04179344

Usability Study of IeHS in Indonesia

An observational study of Human Immunodeficiency Virus and Tuberculosis, run by Bekasi City Public Hospital at 3 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Integrated e-healthcare services (IeHS) web-based app
How many people
25 participants
Where
3 sitesIndonesia
Study dates
5 Aug 2019to 31 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adults males or females involved in HIV and TB treatment, i.e. physicians, pharmacists, HIV and/or TB patients.

Who may be able to join

  • 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.

Who cannot join

  • A severe clinical condition that might impair the hearing or the seeing;
  • Unwillingness to participate.

Trial locations and contacts

3 sites in 1 country.

Indonesia3 sites
  • Bekasi public hospital

    Bekasi, West Java, 17132

  • Jakarta

    Jakarta, 10110

  • Padang

    Padang, West Sumatra, 25111

Other trials in Indonesia

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Integrated e-healthcare services (IeHS) web-based app
Keywords
Pharmaceutical care, HIV, TB, Internet, Surveys and questionnaires, Humans, Pharmacovigilance
Medical subject headings
Acquired Immunodeficiency Syndrome, Tuberculosis, Cell Phone Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated e-healthcare services (IeHS) web-based appOther

    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

Study groups in NCT04179344
Study groupRoleWhat they receive
Integrated e-healthcare services (IeHS) web-based appThis usability study is conducted under 3 steps: IeHS simulation, user experience survey using SUS questionnaire, and qualitative study through the in-depth interview.
Receives: Other: Integrated e-healthcare services (IeHS) web-based app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tasks completion success

    Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation

    Measured: during the simulation for each participant in 3 months of study period

  2. Numbers of tasks errors

    Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation

    Measured: during the simulation for each participant in 3 months of study period

  3. 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.

    Measured: during the simulation for each participant in 3 months of study period

  4. 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).

    Measured: after half-an-hour of the web-app simulation during 3 months of study period

Secondary outcomes (1)
  1. 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.

    Measured: half an hour after web-based app simulation during 3 months of study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start5 Aug 2019
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179344
Sponsor's protocol ID
IeHS_Indonesia
Status last verified
Nov 2019
First submitted
1 Aug 2019
Last updated
27 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participants data are available for only 3 investigators (Lusiana, Najmatul Fitria, and Nahrul Hasan)

Publications

  • GBD Tuberculosis Collaborators. The global burden of tuberculosis: results from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2018 Mar;18(3):261-284. doi: 10.1016/S1473-3099(17)30703-X. Epub 2017 Dec 7.

    PubMed 29223583
  • Marais BJ, Lonnroth K, Lawn SD, Migliori GB, Mwaba P, Glaziou P, Bates M, Colagiuri R, Zijenah L, Swaminathan S, Memish ZA, Pletschette M, Hoelscher M, Abubakar I, Hasan R, Zafar A, Pantaleo G, Craig G, Kim P, Maeurer M, Schito M, Zumla A. Tuberculosis comorbidity with communicable and non-communicable diseases: integrating health services and control efforts. Lancet Infect Dis. 2013 May;13(5):436-48. doi: 10.1016/S1473-3099(13)70015-X. Epub 2013 Mar 24.

    PubMed 23531392
  • Glaziou P, Floyd K, Raviglione MC. Global Epidemiology of Tuberculosis. Semin Respir Crit Care Med. 2018 Jun;39(3):271-285. doi: 10.1055/s-0038-1651492. Epub 2018 Aug 2.

    PubMed 30071543
  • Podlekareva DN, Panteleev AM, Grint D, Post FA, Miro JM, Bruyand M, Furrer H, Obel N, Girardi E, Vasilenko A, Losso MH, Arenas-Pinto A, Cayla J, Rakhmanova A, Zeltina I, Werlinrud AM, Lundgren JD, Mocroft A, Kirk O; HIV/TB study group. Short- and long-term mortality and causes of death in HIV/tuberculosis patients in Europe. Eur Respir J. 2014 Jan;43(1):166-77. doi: 10.1183/09031936.00138712. Epub 2013 Jun 13.

    PubMed 23766333
  • WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390455/

    PubMed 27748093
  • Workneh MH, Bjune GA, Yimer SA. Diabetes mellitus is associated with increased mortality during tuberculosis treatment: a prospective cohort study among tuberculosis patients in South-Eastern Amahra Region, Ethiopia. Infect Dis Poverty. 2016 Mar 21;5:22. doi: 10.1186/s40249-016-0115-z.

    PubMed 27009088
  • Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013;10(1):e1001363. doi: 10.1371/journal.pmed.1001363. Epub 2013 Jan 15.

    PubMed 23458994
  • Patel AR, Kessler J, Braithwaite RS, Nucifora KA, Thirumurthy H, Zhou Q, Lester RT, Marra CA. Economic evaluation of mobile phone text message interventions to improve adherence to HIV therapy in Kenya. Medicine (Baltimore). 2017 Feb;96(7):e6078. doi: 10.1097/MD.0000000000006078.

    PubMed 28207516

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and Tuberculosis, run by Bekasi City Public Hospital at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tasks completion success (time frame: during the simulation for each participant in 3 months of study period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179344, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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