Pharmacist-Led Intervention to Improve TB Treatment Adherence

NCT06608069 | Completed

• 1 other identifier: NMRR ID-22-01964-WWH
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 2

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. 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. 2.To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
3. 3.To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.

Conditions

Tuberculosis, Pulmonary; HIV Coinfection

Outcome Measures

Primary Outcomes (1)

• Level of adherence among PTB patients.

  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).

  6 months

Study Arms (2)

Educational councelling and Reminder.

EXPERIMENTAL

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

Behavioral: Educational counselling

DOTS therapy

NO INTERVENTION

Enrolled patient will be given the DOT therapy for TB.

Interventions

Educational counselling BEHAVIORAL

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

Educational councelling and Reminder.

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy and any medical condition unrelated to TB

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (2)

Hospital Pulau Pinang

George Town, 11800, Malaysia

Location

Universiti Sains Malaysia

George Town, 11800, Malaysia

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; HIV Infections

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Aner H Khan

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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: * How will pharmacist-led interventions improve the medication adherence level of TB and HIV con-infected patients? * Has there been an increase in the adherence level of co-infected patients following pharmacist-led interventions? Participants will be interviewed to measure the level of adherence. If there is a comparison group: Enrolled patient will be counselled and educated by pharmacist on the therapy and benefits of adherence (Control group). Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. Patients will be reminded to take the medication through SMS every day by the pharmacist (Experimental group).

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 23, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)