Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 9:12 PM
Study NCT ID:
NCT06608069
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacist-Led Intervention to Improve TB Treatment Adherence
Sponsor:
Universiti Sains Malaysia
Organization:
Study Overview
Official Title:
Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
RA-15041995
Brief Summary:
The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group
The main question\[s\]it aims to answer are:
1. To evaluate the impact of pharmacist-led educational intervention on treatment adherence among patients with PTB using the health belief model theory and MARS-5.
2. To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
3. To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.
Participants will be interviewed to measure the level of adherence.
If there is a comparison group:
The enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (Control group).
Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (Experimental group).
The main question\[s\]it aims to answer are:
1. To evaluate the impact of pharmacist-led educational intervention on treatment adherence among patients with PTB using the health belief model theory and MARS-5.
2. To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
3. To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.
Participants will be interviewed to measure the level of adherence.
If there is a comparison group:
The enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (Control group).
Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (Experimental group).
Detailed Description:
In 2019, tuberculosis (TB) remained the leading cause of death due to a single infectious pathogen. An estimated 10 million people had TB worldwide, with 1.2 million TB fatalities among Human immune deficiency virus (HIV)-negative people and 208, 000 deaths among HIV-positive people. Literature indicated that treatment adherence for coinfections diseases is difficult due to the complexity, low tolerability, and extended duration of current treatment regimens, especially for both drug-susceptible and drug-resistant TB. There is a need for continuing the quest for low-cost, reliable, and acceptable measures of adherence for the treatment of TB and HIV co-infection. A qualitative approach and pharmacist-led intervention are needed to improve the adherence level of medication for TB patients. The study is aimed to investigate the degree of adherence and evaluate its impacts on clinical outcomes in TB and HIV co-infected patients. To determine the uptake and usage of the intervention, the study will include nested qualitative and economic evaluation sub-studies as well as a process evaluation. A longitudinal study design will adopt to carry out the present study, involving TB and HIV co-infected patients in either the pharmacist-led intervention (adherence and medication reminder, follow-up reminders, and counselling) or control arm. To determine the uptake and usage of the intervention, the study will include theoretical and conceptual models and theories. The study will conclude with targeted efforts of Pharmacist led intervention to improve and sustain excellent adherence in the real-world clinical setting which is critical for maximizing the effectiveness of each medication and treatment. These innovative technologies can thereby be harnessed to improve adherence to TB and HIV regimens in Malaysia and worldwide.
Study Oversight
Has Oversight DMC:
False
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?: