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临床试验/NCT06608069
NCT06608069已完成不适用

Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
383
试验地点
2
主要终点
Level of adherence among PTB patients.

研究概览

简要总结

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).

详细描述

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.

研究设计

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

盲法说明

To ensure the security of the patients' information, a double-blind randomization technique will be adopted. The computer gives each patient a code number, and the code numbers will then be allocated randomly to the treatment groups. All data will be kept in a database, and backup file with password protectors.

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women aged 18 years or more.
  • •Newly bacteriologically confirmed TB case.

排除标准

  • •Pregnancy and any medical condition unrelated to TB

研究组 & 干预措施

Educational councelling and Reminder.

Experimental

Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence.

干预措施: Educational counselling (Behavioral)

DOTS therapy

No Intervention

Enrolled patient will be given the DOT therapy for TB.

结局指标

主要结局

Level of adherence among PTB patients.

时间窗: 6 months

The patient's level of adherence will be checked using the Health Belief Model Questionnaire and the MARS-5 adherence scale, as well as the patient's interview. The MARS-5 scores will indicate if a patient is adherent or not. Scores are calculated as, Score individual items (5 = never to 1 = always) i.e. high scores = high adherence. Add the individual scores to form a scale score (range = 5 to 25).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AMER HAYAT KHAN

Principal Investigator

Universiti Sains Malaysia

研究点 (2)

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