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Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

Monitoring Patient Compliance With Tuberculosis Treatment Regimens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01690754
Enrollment
2207
Registered
2012-09-24
Start date
2011-03-31
Completion date
2014-11-30
Last updated
2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

SMS, tuberculosis, impact evaluation

Brief summary

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.

Interventions

OTHERInteractive Reminders

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.

Sponsors

Massachusetts Institute of Technology
CollaboratorOTHER
Interactive Research and Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment OutcomesAfter 6 to 8 months of treatmentThe investigators will compare clinically reported treatment outcomes between the intervention and control groups.

Secondary

MeasureTime frameDescription
Physical fitness and mobilityMonthly visits for 6 to 8 months of treatmentThe 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.
Psychological ImpactsMonthly visits for 6 to 8 months of treatmentIn 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.
Self-reported medication adherenceSurprise monthly visits during treatmentMedication 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.
Sputum conversionAt 1, 2, 5, and 6/7 months of treatmentThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026