Effectiveness Of Mobile Application To Improve Adherence To Tuberculosis Treatment

Summary

Tuberculosis (TB) is a major public health concern, where it is among the top ten causes of death and the leading cause of death due to a single infectious agent globally. Providing standard anti-TB therapy for at least six months is recommended as one of the important strategies to control TB epidemic. However, prolonged duration of TB treatment raised issues of non-adherence. Non-adherence to TB therapy could negatively affect clinical and public health outcomes. Introduction of Direct Observed Therapy (DOT) has been used as a standard strategy to improve anti-TB adherence. Nonetheless, the DOT approach has been criticized due to inconvenience, stigma, reduced economic productivity, and reduced quality of life which ultimately could complicate the adherence issues. Apart from that, its effectiveness is debatable. Therefore, digital adherence technology could be an important alternative to DOT. Incorporation of Health Belief Model into the development of digital technology could potentially help to change behaviour and improve medication adherence. Hence, this study aimed to determine the effectiveness, feasibility, and usability of mobile application in improving TB medication adherence. This study proposed to conduct a pilot study to assess feasibility and usability followed by randomized, open-label, control trial among TB patients receiving TB care in several public health clinics in Kota Kinabalu, Putatan, and Penampang, Sabah, Malaysia. The eligible sample will be randomly assigned into mobile application DOT arm (intervention arm) and standard DOT arm (control arm). The primary outcome for this study is the successful completion of 80% or more of treatment observations that was scheduled in the two months following randomization. The secondary outcome measures are continuous variables including health related quality of life (HR-QOL), satisfaction level, and employment status. Multiple logistic regression analysis will be used to determine factors associated with primary outcome. Intention to treat and restricted analysis will be conducted. Independent sample t-test and repeated measures ANOVA will be used to compare the continuous secondary outcome between two intervention arms. The findings from this study are hopefully could provide insight into rethinking TB care delivery in order to achieve better TB treatment outcome.

Conditions

• Tuberculosis

Interventions

OTHER

Mobile Application

the mobile application will be consist of 4 modules which are: video observed therapy, health education, reminder system, and feedback.

OTHER

Direct Observed Therapy

it is a specific strategy that require identification, training, and supervision by various parties such as healthcare worker, community volunteer, or family members to directly monitor the ingestion of anti-TB medication. DOT was aimed to improve medication adherence by active monitoring and documenting the consumption of each dose taken. Conducting DOT is not only limited to directly observe the treatment, but also can assess medication side effects as well as to document the visit and information regarding medications (e.g., frequency and timing of taking medication).

Sponsors & Collaborators

• Ministry of Health, Malaysia

  collaborator OTHER_GOV

• Mohd Fazeli bin Sazali

  lead OTHER

Principal Investigators

• Mohd Fazeli bin Sazali, MD, MPH · Universiti Malaysia Sabah

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2023-05-28

Completion

2023-05-28

Countries

• Malaysia

Study Locations