Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
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|ClinicalTrials.gov Identifier: NCT01690754|
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : March 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Other: Interactive Reminders||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Monitoring Patient Compliance With Tuberculosis Treatment Regimens|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
No Intervention: Control
This arm will receive the regular standard of care given by TB clinics.
Experimental: Interactive Reminders
Patients randomized to this arm will receive Interactive SMS reminders daily.
Other: Interactive 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.
- Treatment Outcomes [ Time Frame: After 6 to 8 months of treatment ]The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
- Physical fitness and mobility [ Time Frame: Monthly visits for 6 to 8 months of treatment ]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.
- Psychological Impacts [ Time Frame: Monthly visits for 6 to 8 months of treatment ]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.
- Self-reported medication adherence [ Time Frame: "Surprise" monthly visits during treatment ]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.
- Sputum conversion [ Time Frame: At 1, 2, 5, and 6/7 months of treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690754
|Jinnah Postgraduate Medical Center|
|Landhi Medical Complex|
|Private GP clinics and Private labs partnering with Interactive Research and Devellopment|
|Sindh Government Hospital - Liaqatabad|
|Sindh Government Hospital - New Karachi|
|Sindh Government Hospital - Qatar|
|Sindh Government Hospital New Karachi Kaali Market|
|Urban Health Center - Landhi|
|Principal Investigator:||Rachel Glennerster, PhD.||Massachusetts Institute of Technology|
|Principal Investigator:||Shama Mohammed, MPA/ID||Interactive Research and Development|
|Principal Investigator:||Aamir J. Khan, MD/PhD.||Interactive Research and Development|