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

NCT04264221 | Unknown DMC

• 1 other identifier: F,1-1/2015/ERB/SZABMU/359
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary TB

Outcome Measures

Primary Outcomes (5)

• TB treatment success rates

  TB treatment success rates defined by the World Health Organization. The investigators will compare clinically reported treatment outcomes between the intervention and control groups.

  24 Months

• Lost to follow-up among adult drug-sensitive tuberculosis patients.

  Lost to follow-up is defined as the difference between the two interventions arms in the proportion of patients who did not start treatment after diagnosis or whose treatment was interrupted for 2 consecutive months or more.

  24 \months

• Patient satisfaction questionnaire (usually after treatment time period or 6 to 12 months).

  Through Questionnaire before and at the end of treatment from both groups

  12 Months

• Quality of life of TB patients

  At baseline and upon completion of the treatment initial phase and after starting the continuous phase of the treatment Quality of life of TB patients will be measured by surveys.Whether the disease-specific patient quality of life scores improved in investigational arm patients from baseline to successful completion of treatment By using pre and post data of quality of life questionnaire

  24 months

• The Knowledge, Attitude and Practices (KAP) of the patients about tuberculosis

  A Knowledge, Attitude and Practices (KAP) survey is a quantitative method (predefined questions formatted in standardized questionnaires) that provides access to quantitative and qualitative information.The KAP of the patients about tuberculosis will be compared at the end of the intervention in the two groups on basis of information about TB prevention and treatment.

  24 months

Secondary Outcomes (8)

• Adherence to treatment among drug-sensitive tuberculosis patients self reported and clinical record will checked for the follow up visits and drug taken

  24 Months

• The patient-level percentage of total doses

  24 Months

• Patient satisfaction questionnaire

  6-12 months

• The proportion of patients improving clinically through questionnaire

  24 months

• Perceptions of Intervention through a questionnaire

  24 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: New management mode

No Intervention Group.

NO INTERVENTION

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.

Interventions

New management mode 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

Also known as: Pharmaceutical care, Mobile text, Financial incentive for mobile use

Intervention Group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farman Ullah Khan: lead
• Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan: collaborator
• Pakistan Institute of Medical Sciences: collaborator
• Quaid i Azam University Islamabad Pakistan: collaborator

Study Sites (2)

National TB Control Program

Islamabad, Islammabd, 46000, Pakistan

RECRUITING

Pakistan Institute of Medical Sciences Islamabad

Islamabad, 46000, Pakistan

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Pharmaceutical Services

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

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yu Fang, Phd

  Xian Jiaotong University China

  STUDY CHAIR

• Asim ur Re, Phd

  Quaid i Azam University Islamabad Pakistan

  STUDY DIRECTOR

• Farman Ull ah Khan, Phd

  Jiaotong University Islamabad Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farman Ull ah Khan, Phd

CONTACT

+0092331-9443131; farmankhan@bs.qau.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (Phd Scholar)

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 11, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)