Clinical trial NCT04264221: Promoting Overall Care and Management Related to Tuberculosis Infection Through Pharmaceutical Care and Text Messaging
Official title: Randomized Trial of Pharmaceutical Care and Text Messaging Intervention to Improve Tuberculosis Care and Management Among Drug-susceptible Patients in Pakistan.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary TB
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan
name: Pakistan Institute of Medical Sciences
name: Quaid i Azam University Islamabad Pakistan
First posted: 2020-02-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men and women
* Newly bacteriologically confirmed TB case (less than a month since diagnosis). This restriction (not more than one-month treatment) does not refer to patients whose most recent treatment outcome was a failure and who were assigned to a new treatment regimen.
* Own a mobile phone which operates on a telecom provider supported by our SMS platform
* Know how to and are able to receive SMS messages or Phone Call (Caretaker want to participate in case original patient do not participate)
* An address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
* No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment.
* Facilities must have at least one TB doctor and one TB nurse available within the facility.
* Willingness to comply with study procedures and provide written informed consent prior to study enrollment.

Exclusion Criteria:

* Diagnosis is extra-pulmonary TB
* Currently enrolled in a clinical trial that prohibits enrollment in another study. Patients are leaving the area within the next six months.
* Patients are known at the start of treatment to require the treatment longer than it is recommended TB Management Guidelines for the appropriate type of TB.
* Previous history of TB, multidrug-resistant (MDR) or extensively drug-resistant (XDR) TB.
* Very ill patient's cognitive or physical disability that prevents full participation in the study such as vision, hearing, physically challenged, inability to swallow medications and unconscious Unable to answer questions.
* Pregnant females (treatment of TB infection will be deferred)
* Patients who are receiving treatment from private clinics (Who are not registered in the government TB sectors and they seek are form private health care facilities.

Primary outcomes:
measure: TB treatment success rates
timeFrame: 24 Months
measure: Lost to follow-up among adult drug-sensitive tuberculosis patients.
timeFrame: 24 \months
measure: Patient satisfaction questionnaire (usually after treatment time period or 6 to 12 months).
timeFrame: 12 Months
measure: Quality of life of TB patients
timeFrame: 24 months
measure: The Knowledge, Attitude and Practices (KAP) of the patients about tuberculosis
timeFrame: 24 months
Secondary outcomes:
measure: Adherence to treatment among drug-sensitive tuberculosis patients self reported and clinical record will checked for the follow up visits and drug taken
timeFrame: 24 Months
measure: The patient-level percentage of total doses
timeFrame: 24 Months
measure: Patient satisfaction questionnaire
timeFrame: 6-12 months
measure: The proportion of patients improving clinically through questionnaire
timeFrame: 24 months
measure: Perceptions of Intervention through a questionnaire
timeFrame: 24 months
measure: Semi-structured interview to check the Feasibility of implementation of the intervention and challenges.
timeFrame: 24 Months
measure: To collect patient-specific cost data related to the successfully treated
timeFrame: 24 Months
measure: Psychological Impacts Mental Health Inventory (MHI)-5; well-demonstrated reliability for detecting psychological disorders also mental health screening tool for TB patients will be used
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National TB Control Program
state: Islammabd
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences Islamabad
Study officials:
affiliation: Xian Jiaotong University China
name: Yu Fang, Phd
role: STUDY_CHAIR
affiliation: Quaid i Azam University Islamabad Pakistan
name: Asim ur Re, Phd
role: STUDY_DIRECTOR
affiliation: Jiaotong University Islamabad Pakistan
name: Farman Ull ah Khan, Phd
role: PRINCIPAL_INVESTIGATOR
References: