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.
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
- Conditions the study is for
- Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations
- 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
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.
- Conditions
- Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations, Mobile Phone Use, Adult
- 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 group | Role | What they receive |
|---|---|---|
| Integrated e-healthcare services (IeHS) web-based app | This 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.
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
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
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
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)
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.
- First posted27 Nov 2019
- Study start5 Aug 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bekasi City Public Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Principal investigator, Lusiana Rusdi Idrus, Bekasi City Public Hospital
- Investigators
- Lusiana R Idrus, Master, Principal investigator, Bekasi City Public Hospital
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 29223583Marais 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 23531392Glaziou 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 30071543Podlekareva 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 23766333WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390455/
PubMed 27748093Workneh 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 27009088Free 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 23458994Patel 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04179344
- Acronym / sponsor ID
- IeHS_Indonesia
- Conditions
- Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations, Mobile Phone Use, Adult
- Keywords
- Pharmaceutical care, HIV, TB, Internet, Surveys and questionnaires, Humans, Pharmacovigilance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bekasi City Public HospitalUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated e-healthcare services (IeHS) web-based app | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults males or females involved in HIV and TB treatment, i.e. physicians, pharmacists, HIV and/or TB patients.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- A severe clinical condition that might impair the hearing or the seeing;
- Unwillingness to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated e-healthcare services (IeHS) web-based appEach 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 | Other | Integrated e-healthcare services (IeHS) web-based app |
Primary outcome
Tasks completion success
Time frame: during the simulation for each participant in 3 months of study period
Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation
Numbers of tasks errors
Time frame: during the simulation for each participant in 3 months of study period
Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation
Average time to complete each task
Time frame: during the simulation for each participant in 3 months of study period
Efficiency is defined as level of efforts use by the study participant to complete the web-app simulation each task.
system usability scale (SUS) score
Time frame: after half-an-hour of the web-app simulation during 3 months of study period
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).
1 secondary outcome
Participant experience using the IeHS web-based app
Time frame: half an hour after web-based app simulation during 3 months of study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Background: PubMed 29223583GBD 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.
- Background: PubMed 23531392Marais 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.
- Background: PubMed 30071543Glaziou 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.
- Background: PubMed 23766333Podlekareva 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.
- Background: PubMed 27748093WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390455/
- Background: PubMed 27009088Workneh 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.
- Background: PubMed 23458994Free 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.
- Background: PubMed 28207516Patel 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.
- Individual participant dataSharing planned: Yes. Individual participants data are available for only 3 investigators (Lusiana, Najmatul Fitria, and Nahrul Hasan)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lusiana R Idrus, Master principal investigator
Bekasi City Public Hospital
3 sites in 1 country: see every site and its status.
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.