Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05259254
Status:
RECRUITING
Last Update Posted:
2022-11-07
First Post:
2022-02-17
Brief Title:
Effectiveness Of Mobile Application To Improve Adherence To Tuberculosis Treatment
Sponsor:
Mohd Fazeli bin Sazali
Organization:
Universiti Malaysia Sabah
Study Overview
Official Title:
Effectiveness Feasibility And Usability Of Mobile Application To Improve Adherence To Tuberculosis Treatment
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 12 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 worlds population or 35 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
The utilization of digital technology to enhance adherence to TB therapy is particularly important and relevant to rethinking TB care delivery In public health perspectives enhancing adherence to anti-TB therapy can help to prevent relapse drug resistance and TB transmission in the community A large nested case control study in Vietnam has found that one of the important predictors of TB recurrence is incomplete adherence to anti-TB therapy In addition TB care has been associated with negative consequences especially in social and financial burden not only because of the disease itself but more importantly because of the treatment Current strategy of Direct Observed Therapy DOT to ensure adherence of patients to TB treatment might cause problems to patients as they are required to come to health facilities in daily manner to take the medication Frequent visits to health clinic could cause disruption to their work reduce productive time and increase the risk of job insecurity Furthermore the disease is mostly affecting the age group with high economic productivity Daily visits to healthcare facilities also could cause inconvenience to patients due to increase in travel time waiting hours and reduced participation in social activities In addition the disease and treatment itself also can cause a significant impact on a patients life such as quality of life physical psychological and emotional wellbeing
The use of digital technology in TB care provides an alternative in managing TB When Direct Observed Therapy DOT has been introduced and implemented as one of the key strategies to improve adherence to TB therapy in the early 1990s little consideration is taken to look at the needs of patients especially among those who are economically productive According to a recent systematic review it was showed that DOTs effectiveness is varied compared to self-administered therapy For example DOT by family members was found to be not superior in improving treatment outcomes compared to self-administered therapy However institutional DOT provided for latent TB infection was found to be effective in improving treatment completion The finding is consistent with another systematic review which found that treatment success was low and intervention using DOT was not substantially improving treatment success The use of digital technology in increasing adherence to TB therapy could help to reduce inconvenience to patients because of travelling to health facilities risk of hospital acquired infection among visitors in health facilities and reduces the burden of supervision on healthcare workers
Digital adherence technology might have several advantages over conventional strategy in TB care especially using DOT In a randomized clinical trial involving TB patients in UK it has found that the use of video observed therapy VOT was an effective approach in TB therapy observation compared to DOT VOT also was found to be the preferred method in treatment observation across a broad range of settings providing a more acceptable effective and cheaper option for supervision of daily and multiple daily doses than DOT In addition VOT also a better option as it was proven in reducing observation time reduced cost incurred because of observation users preference and better psychosocial impact
13 Justification Lack of adherence to anti-TB medication has been found to be associated with acquired drug resistance TB relapse TB complication treatment failure and ongoing transmission of disease in community Implementation of digital adherence technology such as using the mobile application can potentially improving medication adherence However many of these technology were lacking in incorporation of behavioral change model in their planning and development stage which explains the disappointing outcomes of many digital technology products It is very important to understand that medication adherence is closely related to human behavior and motivation and adoption of behavioral change theory into intervention can potentially affect medication adherence and ultimately improving treatment success Thus this study intended to adopt the Health Belief Model one of the most common behavioral change theories into development of mobile application
Digital adherence technology has been tested in various countries in the past and it was found to be varied in effectiveness possible because of differences in settings situation users belief and knowledge Thus adopting the digital adherence technology in improving medication adherence would be tailored to Malaysian settings that is diverse in sociocultural background and beliefs Studying the effectiveness of this technology in local population could provide knowledge to develop strategies to improve medication adherence and treatment success in the TB control program Furthermore there was no published study that was conducted among TB patients in Malaysian settings to identify the level of TB adherence as well as its effectiveness of various interventions in randomized clinical trials
Research hypothesis
1 There are no significant differences in proportion of participants receiving 80 of their total planned dose of medications in the 2 months following the randomization in between mobile application DOT with standard DOT users
2 There are no significant differences in health-related quality of life mean score in between mobile application DOT with standard DOT group
3 There are no significant differences in mean participants satisfaction score in between mobile application DOT with standard DOT group
4 There are no significant differences in mean time loss due treatment observation between mobile application DOT and standard DOT group
5 There are no significant differences in mean income loss due to treatment observation between mobile application DOT and standard DOT group
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 worlds population or 35 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
The utilization of digital technology to enhance adherence to TB therapy is particularly important and relevant to rethinking TB care delivery In public health perspectives enhancing adherence to anti-TB therapy can help to prevent relapse drug resistance and TB transmission in the community A large nested case control study in Vietnam has found that one of the important predictors of TB recurrence is incomplete adherence to anti-TB therapy In addition TB care has been associated with negative consequences especially in social and financial burden not only because of the disease itself but more importantly because of the treatment Current strategy of Direct Observed Therapy DOT to ensure adherence of patients to TB treatment might cause problems to patients as they are required to come to health facilities in daily manner to take the medication Frequent visits to health clinic could cause disruption to their work reduce productive time and increase the risk of job insecurity Furthermore the disease is mostly affecting the age group with high economic productivity Daily visits to healthcare facilities also could cause inconvenience to patients due to increase in travel time waiting hours and reduced participation in social activities In addition the disease and treatment itself also can cause a significant impact on a patients life such as quality of life physical psychological and emotional wellbeing
The use of digital technology in TB care provides an alternative in managing TB When Direct Observed Therapy DOT has been introduced and implemented as one of the key strategies to improve adherence to TB therapy in the early 1990s little consideration is taken to look at the needs of patients especially among those who are economically productive According to a recent systematic review it was showed that DOTs effectiveness is varied compared to self-administered therapy For example DOT by family members was found to be not superior in improving treatment outcomes compared to self-administered therapy However institutional DOT provided for latent TB infection was found to be effective in improving treatment completion The finding is consistent with another systematic review which found that treatment success was low and intervention using DOT was not substantially improving treatment success The use of digital technology in increasing adherence to TB therapy could help to reduce inconvenience to patients because of travelling to health facilities risk of hospital acquired infection among visitors in health facilities and reduces the burden of supervision on healthcare workers
Digital adherence technology might have several advantages over conventional strategy in TB care especially using DOT In a randomized clinical trial involving TB patients in UK it has found that the use of video observed therapy VOT was an effective approach in TB therapy observation compared to DOT VOT also was found to be the preferred method in treatment observation across a broad range of settings providing a more acceptable effective and cheaper option for supervision of daily and multiple daily doses than DOT In addition VOT also a better option as it was proven in reducing observation time reduced cost incurred because of observation users preference and better psychosocial impact
13 Justification Lack of adherence to anti-TB medication has been found to be associated with acquired drug resistance TB relapse TB complication treatment failure and ongoing transmission of disease in community Implementation of digital adherence technology such as using the mobile application can potentially improving medication adherence However many of these technology were lacking in incorporation of behavioral change model in their planning and development stage which explains the disappointing outcomes of many digital technology products It is very important to understand that medication adherence is closely related to human behavior and motivation and adoption of behavioral change theory into intervention can potentially affect medication adherence and ultimately improving treatment success Thus this study intended to adopt the Health Belief Model one of the most common behavioral change theories into development of mobile application
Digital adherence technology has been tested in various countries in the past and it was found to be varied in effectiveness possible because of differences in settings situation users belief and knowledge Thus adopting the digital adherence technology in improving medication adherence would be tailored to Malaysian settings that is diverse in sociocultural background and beliefs Studying the effectiveness of this technology in local population could provide knowledge to develop strategies to improve medication adherence and treatment success in the TB control program Furthermore there was no published study that was conducted among TB patients in Malaysian settings to identify the level of TB adherence as well as its effectiveness of various interventions in randomized clinical trials
Research hypothesis
1 There are no significant differences in proportion of participants receiving 80 of their total planned dose of medications in the 2 months following the randomization in between mobile application DOT with standard DOT users
2 There are no significant differences in health-related quality of life mean score in between mobile application DOT with standard DOT group
3 There are no significant differences in mean participants satisfaction score in between mobile application DOT with standard DOT group
4 There are no significant differences in mean time loss due treatment observation between mobile application DOT and standard DOT group
5 There are no significant differences in mean income loss due to treatment observation between mobile application DOT and standard DOT group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None