Pulmonary TBNCT04645836
Impact of a Pharmacist-led Patient-centred Care Intervention Along With Text-Message Reminders, on the Management of Newly Diagnosed Tubercular Patients: a Protocol for a Randomized Controlled Trial'.
A study testing New management mode in people with Pulmonary TB and TB, run by Xi'an Jiaotong University at 1 site 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, 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
- 450 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2020to 30 Dec 2021
- 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
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences Islamabad
Islamabad, 46000
About this study
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.
- Conditions
- Pulmonary TB, 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: 6-9 Months
Adherence to treatment among drug-sensitive tuberculosis patients self reported and clinical record will checked for the follow up visits and drug taken
Adherence 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.The measure adherence in TB patients for these determinations, we will measure patients' adherence via combined adherence endpoint consisting of Morisky Medication Adherence Scale and pill count rate.
Measured: 6-9 Months
Secondary outcomes (3)
Health related Quality of Life of TB patients
At baseline and upon completion of the treatment. To measure HRQoL (Health related Quality of Life) Revalidated data assortment tool European Quality of Life Scale EQ 5D 3L
Measured: 6-9 Months
Lost To Follow
Lost to follow up or Treatment defaulters patients will be recorded from TB registers upon completion of the treatment
Measured: 6-9 Months
Patient satisfaction questionnaire
At baseline and upon completion of the treatment. Satisfaction with information can be assessed with the satisfaction with information about medicines scale along with the Beliefs about medicines questionnaire.
Measured: 6-9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences, Quaid i Azam University Islamabad Pakistan
- Responsible party
- Principal investigator, Farman Ullah Khan, Xi'an Jiaotong University
- Investigators
- Yu Fang, Phd, Study chair, Xi'an Jiaotong UniversityAmjad Khan, Phd, Study director, Quaid i Azam University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645836
- Sponsor's protocol ID
- FUKhan
- Status last verified
- Jun 2022
- First submitted
- 15 Nov 2020
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khan FU, Khan FU, Hayat K, Fang Y. Impact of a pharmacist-led patient-centred care intervention along with textmessage reminders, on the management of newly diagnosed tubercular patients: A protocol for a randomized controlled trial. Pak J Med Sci. 2024 Jan-Feb;40(3Part-II):487-491. doi: 10.12669/pjms.40.3.5356.
PubMed 38356837
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmacist-led Patient-centred Care Intervention Along With Text-Message Reminders, on the Management of Newly Diagnosed Tubercular Patients: a Protocol for a Randomized Controlled Trial'.
- ClinicalTrials.gov ID
- NCT04645836
- Acronym / sponsor ID
- FUKhan
- Conditions
- Pulmonary TB, TB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Pakistan Institute of Medical Sciences, Quaid i Azam University Islamabad Pakistan
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Nov 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.
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 useNew 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: 6-9 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.
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: 6-9 Months
Adherence 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.The measure adherence in TB patients for these determinations, we will measure patients' adherence via combined adherence endpoint consisting of Morisky Medication Adherence Scale and pill count rate.
3 secondary outcomes
Health related Quality of Life of TB patients
Time frame: 6-9 Months
Lost To Follow
Time frame: 6-9 Months
Patient satisfaction questionnaire
Time frame: 6-9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Derived from this study: PubMed 38356837Khan FU, Khan FU, Hayat K, Fang Y. Impact of a pharmacist-led patient-centred care intervention along with textmessage reminders, on the management of newly diagnosed tubercular patients: A protocol for a randomized controlled trial. Pak J Med Sci. 2024 Jan-Feb;40(3Part-II):487-491. doi: 10.12669/pjms.40.3.5356.
- Individual participant dataSharing planned: Undecided
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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
Xi'an Jiaotong University
Amjad Khan, Phd study director
Quaid i Azam University Islamabad
1 site 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 and TB, run by Xi'an Jiaotong University at 1 site 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: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB treatment success rates (time frame: 6-9 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645836, which also lists 1 linked publication.
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 29 Jun 2022.