Effectiveness Of Mobile Application To Improve Adherence To Tuberculosis Treatment

NCT05259254 | Unknown

• 1 other identifier: PatuhTB01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

tuberculosis; adherence; mobile application

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Usability Score assessed by validated English and Malay version of Usability Scale Questionnaire for the Assessment of Mobile Apps

  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

Study Arms (2)

Standard Direct Observed Therapy (DOT)

PLACEBO COMPARATOR

After a patient was diagnosed with TB, they will be provided TB therapy which is consist of health education and anti-TB medication. Patient that is not in life-threatening condition typically will be treated as outpatient. Patient will receive medication that will be monitored closely through DOT, which is either by health facilities (by healthcare staff), or community (by family members or community members). Observation of medication will be conducted daily, and the health care staff will sign the DOT diary provided to the patient to verify the medication consumption.

Other: Direct Observed Therapy

Mobile application DOT

ACTIVE COMPARATOR

The mobile application will be consisting of four basic modules which are: 1) reminder system, 2) visual observed therapy, 3) feedback, and 4) health education. Researcher will teach patient on how to record, and send video of every dose of medication ingested every day. Participants also required to show their mouth is empty by opening their mouth and sticking out their tongue. The participants also are required to record and send the self-recorded video of ingesting the medication daily. Researcher will subsequently view the video through a password protected website. The observation of taking medication will be completed until the end of study period.

Other: Mobile Application

Interventions

Mobile Application OTHER

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

Mobile application DOT

Direct Observed Therapy OTHER

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).

Standard Direct Observed Therapy (DOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohd Fazeli bin Sazali: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Mohd Fazeli bin Sazali

Kota Kinabalu, Sabah, 88450, Malaysia

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mohd Fazeli bin Sazali, MD, MPH

  Universiti Malaysia Sabah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Fazeli bin Sazali, MD, MPH

CONTACT

+60133870136; drmohdfazeli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Following the diagnosis of TB by physician, patients will be directed to take daily medication of antiTB drugs. Patients will be randomised to two different groups of intervention which are standard directly observed therapy (DOT) and mobile application DOT.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: June 1, 2022
• Primary Completion: May 28, 2023
• Study Completion: May 28, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)