Tuberculosis Clinical Trial
Official title:
Effectiveness, Feasibility, And Usability Of Mobile Application To Improve Adherence To Tuberculosis Treatment
NCT number | NCT05259254 |
Other study ID # | PatuhTB01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | May 28, 2023 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 28, 2023 |
Est. primary completion date | May 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Mohd Fazeli bin Sazali | Kota Kinabalu | Sabah |
Lead Sponsor | Collaborator |
---|---|
Mohd Fazeli bin Sazali | Ministry of Health, Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence Level assessed by number of participants completed daily medication observation | 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. | 2 months | |
Secondary | 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 | Retention rate can be calculated by (number of active users of mobile application across period of observation / total number of users at day 0 of observation) x 100. AND Rate of completion of the intervention. Can be calculated by (i.e., number of participants who can complete the intervention from training to uploading the video of medication consumption / total number of users recruited at day 0) x 100. |
2 months | |
Secondary | Usability Score assessed by validated English and Malay version of Usability Scale Questionnaire for the Assessment of Mobile Apps | Usability will be assessed using a validated English and Malay version of Usability Scale Questionnaire for the Assessment of Mobile Apps by John Brooke (1986) (original questionnaire) & Muhammad Fadhil (Marzuki et al., 2018) (Malay version questionnaire). Usability questionnaire is consisting of 10 items questionnaire using 5-points Likert scale from 0 (strongly disagree) to 5 (strongly agree). The overall score will be calculated from the summation of all items scores multiply with 2.5. The overall score will be ranged from 0 to 100. According to previous study by original author and Malay version of usability score (Marzuki et al., 2018), usability score of 68 and above was recommended to indicate good usability of mobile application. The Cronbach Alpha of Malay version of questionnaire was 0.85. | 2 months | |
Secondary | Health-related quality of life (HR-QOL) assessed by English and Malay Version of EUROQOL EQ5D-3L Questionnaire | HR-QOL will be assessed using a standardised EUROQOL EQ5D-3L instrument. The questionnaire was validated and available in Malay and English language. The questionnaire is consisting of two pages; the EQ5D descriptive system and EQ5D visual analogue scale (EQ-VAS). The EQ5D descriptive system comprises five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Meanwhile, each of the dimensions has three levels of severity, namely no problem, mild to moderate, and severe problem. The respondents will be asked to indicate their current health status by checking the box against the most appropriate answer for each of the five dimensions. The EQ-VAS assess the respondent's self-rated health in term of the vertical visual analogue scale, where there are two endpoints which are labelled as 'the best health you can imagine' and 'the worst health you can imagine'. | 2 months | |
Secondary | Patient satisfaction assessed by the English and Malay Version of Short-Form Patient Satisfaction Questionnaire (PSQ-18) | participants will be assessed using the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which was originally developed by Marshall and Hays (Marshall & Hays, 1994). PSQ-18 consists of eighteen items with seven dimensions, which measures general satisfaction (Item 3 and 17), technical quality (Item 2, 4, 6, and 14), interpersonal manner (Item 10 and 11), communication (Item 1 and 13), financial aspect (Item 5 and 7), time spent with a healthcare provider (Item 12 and 15), and accessibility and convenience (Item 8,9,16, and 18). A five-points Likert scale will be used to score the eighteen items. | 2 months | |
Secondary | Employment assessed by asking the total monthly household income and total time needed for medication observation | participants will be asked in two questions regarding their employment Loss of income as the result of treatment observation. The participants will be asked to estimate how much he loss in previous week in Ringgit Malaysia (RM) Missed time from paid/unpaid work as the result of treatment observation. The participants will be asked to estimate how much time he loss in the previous week in minutes. |
2 months |
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