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

November 30, 2020 updated by: Farman Ullah Khan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 46000
        • Active, not recruiting
        • Pakistan Institute of Medical Sciences Islamabad
    • Islammabd
      • Islamabad, Islammabd, Pakistan, 46000
        • Recruiting
        • National TB Control Program
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • Pharmaceutical care, Mobile text, Financial incentive for mobile use
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TB treatment success rates
Time Frame: 24 Months
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.
Time Frame: 24 \months
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).
Time Frame: 12 Months
Through Questionnaire before and at the end of treatment from both groups
12 Months
Quality of life of TB patients
Time Frame: 24 months
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
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment among drug-sensitive tuberculosis patients self reported and clinical record will checked for the follow up visits and drug taken
Time Frame: 24 Months
Adherence [ Time Frame: Assessed daily from date of randomization until the date of a documented treatment outcome, up to 24 months after study enrollment date.Counting the number of administered pills, adequate adherence is more than 80% of administered pills.
24 Months
The patient-level percentage of total doses
Time Frame: 24 Months
Each patient based on the total number of doses missed out of the total possible number of doses), measured using treatment adherence records reported by triangulated by pill count after 6 months.
24 Months
Patient satisfaction questionnaire
Time Frame: 6-12 months
Perceptions and opinions (if the intervention was helpful, non-helpful, effectiveness) in the intervention arm will be assessed after the study follow-up through a questionnaire of a subset of enrolled individuals at the completion of the participant's treatment.
6-12 months
The proportion of patients improving clinically through questionnaire
Time Frame: 24 months
Proportion of patients improving clinically (cough, weight gain, night sweats, fever, appetite to compare the treatment completion rates between participants randomized to intervention without intervention with weekly SMS reminders and pharmaceutical care.
24 months
Perceptions of Intervention through a questionnaire
Time Frame: 24 months
Perceptions and opinions (if the intervention was helpful, non-helpful, effectiveness) in the intervention arm will be assessed after the study follow-up through a questionnaire of a subset of enrolled individuals at the completion of the participant's treatment.
24 months
Semi-structured interview to check the Feasibility of implementation of the intervention and challenges.
Time Frame: 24 Months
Semi-structured interview with participants to understand challenges, recommendations for improvement. Feasibility of implementation of the intervention and challenges.
24 Months
To collect patient-specific cost data related to the successfully treated
Time Frame: 24 Months
To collect patient-specific cost data related to the treatment of arms with the intervention.
24 Months
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
Time Frame: 6-12 months
In order to gauge the psychological impacts of the system, the investigators will be looking at participants' perceptions on the likelihood of being cured, how they feel on a given day using the pain scale, and how supported they feel. This data will be collected through questionnaires conducted at each monthly mid-line visit.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farman Ullah Khan

Collaborators

Pakistan Institute of Medical Sciences
Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan
Quaid i Azam University Islamabad Pakistan

Investigators

  • Study Chair: Yu Fang, Phd, Xian Jiaotong University China
  • Study Director: Asim ur Re, Phd, Quaid i Azam University Islamabad Pakistan
  • Principal Investigator: Farman Ull ah Khan, Phd, Jiaotong University Islamabad Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F,1-1/2015/ERB/SZABMU/359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary TB

Clinical Trials on New management mode

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe