Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

Study Overview
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Brief Summary
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In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify. IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.

Official Title
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Monitoring Patient Compliance With Tuberculosis Treatment Regimens

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: Interactive Reminders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New, smear-positive drug susceptible TB who have been on treatment for less than two weeks Access to a mobile phone (self-reported) Intending to reside in Karachi for the duration of their treatment Exclusion Criteria: Patients who do not have regular access to a mobile phone Patients who have previously received TB treatment Patients who have another member in their household who is already a part of the study

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This arm will receive the regular standard of care given by TB clinics. | |
| Experimental: Interactive Reminders<br>Patients randomized to this arm will receive Interactive SMS reminders daily. | Other: Interactive Reminders<br>* Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcomes | The investigators will compare clinically reported treatment outcomes between the intervention and control groups. | After 6 to 8 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness and mobility | The investigators will measure physical fitness and mobility through questionnaires conducted with patients during household visits each month that they are on treatment. The investigators are using two indices. The physical fitness index will record respondents ability to perform certain tasks. The mobility index will record the mobility of participants. | Monthly visits for 6 to 8 months of treatment | 
| Psychological Impacts | 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. | Monthly visits for 6 to 8 months of treatment | 
| Self-reported medication adherence | Medication adherence will be measured through self-reports by participants on whether they took their TB medication in the past 24 hours. This data will be collected through monthly surprise visits to the participants' houses. | Surprise monthly visits during treatment | 
| Sputum conversion | The investigators will look at sputum test results for patients at months 2, 5, and 6/7 of their treatment to compare when sputum conversion occurs between the intervention and control group at these three periods during their treatment. | At 1, 2, 5, and 6/7 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMS, tuberculosis, impact evaluation