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临床试验/NCT05259254
NCT05259254招募中不适用

Effectiveness, Feasibility, And Usability Of Mobile Application To Improve Adherence To Tuberculosis Treatment

Mohd Fazeli bin Sazali2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
Adherence Level assessed by number of participants completed daily medication observation

研究概览

简要总结

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.

详细描述

Background Tuberculosis (TB) is an infectious disease that is caused by a bacterium called Mycobacterium tuberculosis. Worldwide, TB is considered as one of the major public health threats, where it is among the top ten causes of death and a leading cause of death due to a single infectious agent. Even though the most form of TB infection are treatable, and death is preventable, World Health Organization (WHO) estimated that 10 million people were infected and fell ill due to TB infection in 2019 and causing death to 1.2 million people. In addition, TB infection was identified as the number one cause of death among people living with HIV, where it was estimated 208 000 deaths or approximately 40% among HIV positive individuals died due to TB infection.

TB infection and the death is preventable using a standard 6 months medication regime. However, long duration of anti-TB treatment posed significant challenges to TB patients. Non-adherence to anti-TB therapy is one of the major challenges in TB management. A recent study in South Africa estimated that treatment loss is mainly occurred at the point of treatment completion, with only 53% of overall TB cases are able to complete treatment. Failure to complete anti TB therapy can lead to poor treatment outcome, such as the increased risk of relapse, acquired drug resistant TB, treatment failure, progression of disease leading to complication, risk of death, and ongoing transmission of disease in the community.

Adherence to TB therapy is critical for the success of TB treatment. Adherence to TB therapy is multidimensional, which is comprised of five factors, namely socioeconomic factor, health system factor, condition-related factor, therapy-related factor, and patient-related factor.

Ending TB epidemic is one of the main target under the Sustainable Development Goals (SDG) which require a holistic approach that combines biomedical, public health, social, and economic intervention. Therefore, tackling the issues of non-adherence to TB therapy and follow-up requires a concerted effort from a wide range of social determinants of TB disease. Under the End TB strategy, it encompassed a comprehensive package of intervention, which consists of three pillars. The first pillar emphasized on the integrated, patient-centered care and prevention, which require the need to strengthen and expand the core functions of TB programs. It involves the need to embrace the new strategies and technologies to enhance patient care.

The expansion of mobile phone and internet access to various parts of the world has provide a good opportunity to incorporate the utilization of digital technology into public health practice. According to the global report by Global System for Mobile Communication Association (GSMA), almost half of world's population or 3.5 billion individuals are connected to the internet, where more than half of people in low middle-income country has been using mobile phone as the primary mean of internet access. Even though affordability, low level of digital literacy and skills, and perceived lack of relevance might serve as a barrier in the use of mobile phone, the gap in the usage of mobile phone has been decreased from 24% to 10% worldwide, which mainly contributed by increased affordability and internet access. Department of Statistics Malaysia (DOSM) reported that in 2019, 98% of Malaysian populations are using mobile phone. Among those who are using mobile phone, the smartphone users have been substantially increased from 89% in 2018 to 91% in 2019. High usage of mobile phone and internet connectivity among Malaysian population may provide an opportunity for an alternative strategy in enhancing the prevention and care of TB patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed and all existing TB cases in maintenance phase.
  • Age 18 years old and above
  • Receiving standard therapy of daily antituberculosis drug according to Malaysian Clinical Practice Guideline of Tuberculosis 3rd Edition 2011.

排除标准

  • No access to smart phone
  • On injectable type of anti-TB
  • Less than two months remaining in current treatment regime.
  • Not planned to continue follow ups in study location in the next two months.
  • Patients with psychiatric problem and no family members to assist taking medication at home.
  • Not being able to understand Malay and English language
  • Patients that health care staff consider needed intensive face-to-face support for emotional, medical, or structural reasons, as well as imminent risk of loss to follow up.
  • Unconsented to participate

结局指标

主要结局

Adherence Level assessed by number of participants completed daily medication observation

时间窗: 2 months

This primary measure of outcome is to assess the level of adherence to anti-TB treatment. Decision to use 80% as cut off point is based on previous literature which concluded that adequate adherence was defined by the threshold of 76% to 80% of intended dose taken. According to the Malaysian national tuberculosis guideline, if the interruption of medication less than 20% during maintenance phase, the treatment might be stopped, provided that if the sputum AFB smear is negative. Thus, 80% cut off point is selected as a proxy measures to determine adherence to medication. 80% and more is considered as high adherence and less than 80% is considered as low adherence to medication.

次要结局

  • Usability Score assessed by validated English and Malay version of Usability Scale Questionnaire for the Assessment of Mobile Apps(2 months)
  • Retention and Completion Rate assessed by number of active users of mobile application and number of participants who can complete intervention from the date of randomization(2 months)
  • Health-related quality of life (HR-QOL) assessed by English and Malay Version of EUROQOL EQ5D-3L Questionnaire(2 months)
  • Patient satisfaction assessed by the English and Malay Version of Short-Form Patient Satisfaction Questionnaire (PSQ-18)(2 months)
  • Employment assessed by asking the total monthly household income and total time needed for medication observation(2 months)

研究者

发起方
Mohd Fazeli bin Sazali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohd Fazeli bin Sazali

Principle Investigator

Universiti Malaysia Sabah

研究点 (2)

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