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

NCT ID: NCT04264221

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-12-01

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.

Conditions

Pulmonary TB

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

New management mode intervention: Pharmaceutical care A more recent strategy is pharmaceutical care, where a hospital provides timely patient education, monitoring and management of adverse drug reactions, identifying other drug-related problems, and an evaluation of treatment adherence by a clinical pharmacist. 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.

Short Message Service and Phone calls daily use of the mobile phone for a TB treatment will support pharmaceutical care. TB patients or family members will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.

Group Type: EXPERIMENTAL

New management mode

Intervention Type: BEHAVIORAL

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

No Intervention Group.

Treatment Group included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by World Health Organization and routine treatment group (6 months treatment regimen); Routine health education provided by health care professionals.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Pharmaceutical care, Mobile text, Financial incentive for mobile use

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan

UNKNOWN

Sponsor Role: collaborator

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: collaborator

Quaid i Azam University Islamabad Pakistan

UNKNOWN

Sponsor Role: collaborator

Farman Ullah Khan

OTHER

Sponsor Role: lead

Responsible Party

Farman Ullah Khan

Principal Investigator (Phd Scholar)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yu Fang, Phd

Role: STUDY_CHAIR

Xian Jiaotong University China

Asim ur Re, Phd

Role: STUDY_DIRECTOR

Quaid i Azam University Islamabad Pakistan

Farman Ull ah Khan, Phd

Role: PRINCIPAL_INVESTIGATOR

Jiaotong University Islamabad Pakistan

Locations

National TB Control Program

Islamabad, Islammabd, Pakistan

Site Status: RECRUITING

Pakistan Institute of Medical Sciences Islamabad

Islamabad, , Pakistan

Site Status: ACTIVE_NOT_RECRUITING

Countries

Pakistan

Central Contacts

Farman Ull ah Khan, Phd

Role: CONTACT

Phone: +0092331-9443131

Email: farmankhan@bs.qau.edu.pk

Facility Contacts

Farman Ull ah Khan

Role: primary

Other Identifiers

F,1-1/2015/ERB/SZABMU/359

Identifier Type: -

Identifier Source: org_study_id