NCT04264221

Promoting Overall Care and Management Related to Tuberculosis Infection Through Pharmaceutical Care and Text Messaging

Randomized Trial of Pharmaceutical Care and Text Messaging Intervention to Improve Tuberculosis Care and Management Among Drug-susceptible Patients in Pakistan.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Farman Ullah Khan · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This project aims to standardize the management of "Pharmaceutical care with the two-way text messages and incentive for mobile usage during the treatment for tuberculosis patients, to improve the outcomes and compliance, reduce the risk of transmission and to evaluate the patient perspective in terms of their quality of life, shared decision making and satisfaction with services provided.

Detailed description

Tuberculosis (TB) remains a top ten leading cause of death globally despite it being a largely curable disease. New effective treatment supervision strategies are needed particularly in low-resource high TB burden settings and a potential solution is in the hands of nearly every patient - a mobile phone. Modern modular design mobile phone software applications ("apps") hold great promise to address this unmet need. Current technologies allow for rapid design modification based on end-user needs, implementation of native operating system (e.g., Android) versions for users with inconsistent internet access, and the integration of the patients' experiences with electronic health records using industry standards. Apps can perform multiple functions (e.g., automated reminders, symptom tracking, secure messaging, and multi-media education). Another strategy is pharmaceutical care which is utilized to enhance TB treatment compliance along with usage of mobile technologies, where clinical pharmacists provide patient education to improve the patient's knowledge on the disease and medication use and address the patient's drug-related problems. The use of a pharmaceutical care model to improve treatment outcomes and enhance adherence is on the rise in healthcare organizations. At the first visit, the clinical pharmacist provides a mobile phone number and encourages patients to contact them anytime if they need any consultation on the TB treatment. Patients will make prior arrangements with a study pharmacist to determine a convenient meeting place. These meetings will continue until treatment completion. To our knowledge, worldwide there has only been no randomized controlled trial (RCT) which has described the use of both pharmaceutical care model and two-way Short Message Service (SMS) communication with financial incentives (mobile money transfer cover healthcare costs related to SMS charges) to improve treatment outcomes. To find out both the pharmaceutical care model and two-way SMS communication with financial incentives would be helpful for TB patients in Pakistan. Therefore investigator aimed a study, to find out the effectiveness of trial gauged with the impact of the suggested model on the improved adherence, treatment completion, health-related quality of life and satisfaction with TB care. Investigator will also explore implementation questions regarding acceptability, cost-effectiveness and long-term effects to inform future scale-up in remote areas of Pakistan and other low- and middle-income countries. The functions allow the participant to engage in self-management of their care: self-report daily administration of their TB medication, self-report side effects if applicable, review educational material on TB disease protects other members of the family, encourage treatment, shows complete adherence, increase the relationship between patients and care provider and improves quality of life.

Conditions

• Pulmonary TB

Interventions

Type	Name	Description
BEHAVIORAL	New management mode	* New management mode intervention: Pharmaceutical care * SMS text messages and Phone Calls * Behavioural Educational leaflet * Self-Administered Therapy A financial incentive for mobile use

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-02-11
• Last updated: 2020-12-02

Locations

2 sites across 1 country: Pakistan