Pulmonary TBNCT04264221
Promoting Overall Care and Management Related to Tuberculosis Infection Through Pharmaceutical Care and Text Messaging
A study testing New management mode in people with Pulmonary TB, run by Farman Ullah Khan at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Pulmonary TB
- What is being tested?
- New management mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Feb 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 1 recruiting
- Recruiting
National TB Control Program
Islamabad, Islammabd, 46000
Farman Ull ah Khan, +92331-3319443131, farmankhan@bs.qau.pk
- Active, not recruiting
Pakistan Institute of Medical Sciences Islamabad
Islamabad, 46000
About this study
Official title: 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.
Read the 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
- Being tested
- New management mode
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New management modeBehavioural
Also called Pharmaceutical care, Mobile text, Financial incentive for mobile use
- New management mode intervention: Pharmaceutical care
- SMS text messages and Phone Calls
- Behavioural Educational leaflet
- Self-Administered Therapy A financial incentive for mobile use
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: 24 Months
The patient-level percentage of total doses
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.
Measured: 24 Months
Patient satisfaction questionnaire
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.
Measured: 6-12 months
The proportion of patients improving clinically through questionnaire
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.
Measured: 24 months
Perceptions of Intervention through a questionnaire
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.
Measured: 24 months
Semi-structured interview to check the Feasibility of implementation of the intervention and challenges.
Semi-structured interview with participants to understand challenges, recommendations for improvement. Feasibility of implementation of the intervention and challenges.
Measured: 24 Months
To collect patient-specific cost data related to the successfully treated
To collect patient-specific cost data related to the treatment of arms with the intervention.
Measured: 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
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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farman Ullah Khan
- Sponsor type
- University, hospital or other
- Collaborators
- Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan Institute of Medical Sciences, Quaid i Azam University Islamabad Pakistan
- Responsible party
- Sponsor-investigator, Farman Ullah Khan, Xi'an Jiaotong University
- Investigators
- Yu Fang, Phd, Study chair, Xian Jiaotong University ChinaAsim ur Re, Phd, Study director, Quaid i Azam University Islamabad PakistanFarman Ull ah Khan, Phd, Principal investigator, Jiaotong University Islamabad Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264221
- Sponsor's protocol ID
- F,1-1/2015/ERB/SZABMU/359
- Status last verified
- Nov 2020
- First submitted
- 6 Feb 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Pharmaceutical Care and Text Messaging Intervention to Improve Tuberculosis Care and Management Among Drug-susceptible Patients in Pakistan.
- ClinicalTrials.gov ID
- NCT04264221
- Acronym / sponsor ID
- F,1-1/2015/ERB/SZABMU/359
- Conditions
- Pulmonary TB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Farman Ullah KhanUniversity, hospital or other
- Collaborators
- Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan Institute of Medical Sciences, Quaid i Azam University Islamabad Pakistan
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: New management modeNew 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. |
| 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New management modeAlso: Pharmaceutical care, Mobile text, Financial incentive for mobile use* New management mode intervention: Pharmaceutical care * SMS text messages and Phone Calls * Behavioural Educational leaflet * Self-Administered Therapy A financial incentive for mobile use | Behavioural | Intervention Group |
Primary outcome
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.
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.
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
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
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.
8 secondary outcomes
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
The patient-level percentage of total doses
Time frame: 24 Months
Patient satisfaction questionnaire
Time frame: 6-12 months
The proportion of patients improving clinically through questionnaire
Time frame: 24 months
Perceptions of Intervention through a questionnaire
Time frame: 24 months
Semi-structured interview to check the Feasibility of implementation of the intervention and challenges.
Time frame: 24 Months
To collect patient-specific cost data related to the successfully treated
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Fang, Phd study chair
Xian Jiaotong University China
Asim ur Re, Phd study director
Quaid i Azam University Islamabad Pakistan
Farman Ull ah Khan, Phd principal investigator
Jiaotong University Islamabad Pakistan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New management mode in people with Pulmonary TB, run by Farman Ullah Khan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farman Ull ah Khan, Phd (+0092331-9443131, farmankhan@bs.qau.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB treatment success rates (time frame: 24 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.