NCT04179344

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

August 1, 2019

Last Update Submit

November 26, 2019

Conditions

Keywords

Pharmaceutical careHIVTBInternetSurveys and questionnairesHumansPharmacovigilance

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Participant experience using the IeHS web-based app

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

Study Arms (1)

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.

Other: Integrated e-healthcare services (IeHS) web-based app

Interventions

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

Integrated e-healthcare services (IeHS) web-based app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bekasi public hospital

Bekasi, West Java, 17132, Indonesia

Location

Padang

Padang, West Sumatra, 25111, Indonesia

Location

Jakarta

Jakarta, 10110, Indonesia

Location

Related Publications (8)

  • 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.

    PMID: 29223583BACKGROUND
  • 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.

    PMID: 23531392BACKGROUND
  • 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.

    PMID: 30071543BACKGROUND
  • 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.

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

    PMID: 27748093BACKGROUND
  • 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.

    PMID: 27009088BACKGROUND
  • 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.

    PMID: 23458994BACKGROUND
  • 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.

    PMID: 28207516BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosisCell Phone Use

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesCommunicationBehaviorSocial Behavior

Study Officials

  • Lusiana R Idrus, Master

    Bekasi City Public Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

August 1, 2019

First Posted

November 27, 2019

Study Start

August 5, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Individual participants data are available for only 3 investigators (Lusiana, Najmatul Fitria, and Nahrul Hasan)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
November 2019 and will become available until publication
Access Criteria
Only for investigators

Locations