Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
March 18, 2015 updated by: Shama Mohammed, Interactive Research and Development
Monitoring Patient Compliance With Tuberculosis Treatment Regimens
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
2207
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karachi, Pakistan
- Indus Hospital
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Karachi, Pakistan
- Civil Hospital
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Karachi, Pakistan
- Jinnah Postgraduate Medical Center
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Karachi, Pakistan
- Landhi Medical Complex
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Karachi, Pakistan
- Private GP clinics and Private labs partnering with Interactive Research and Devellopment
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Karachi, Pakistan
- Sindh Government Hospital - Liaqatabad
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Karachi, Pakistan
- Sindh Government Hospital - New Karachi
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Karachi, Pakistan
- Sindh Government Hospital - Qatar
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Karachi, Pakistan
- Sindh Government Hospital New Karachi Kaali Market
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Karachi, Pakistan
- UHC-New Karachi
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Karachi, Pakistan
- Urban Health Center - Landhi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
This arm will receive the regular standard of care given by TB clinics.
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Experimental: Interactive Reminders
Patients randomized to this arm will receive Interactive SMS reminders daily.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment Outcomes
Time Frame: After 6 to 8 months of treatment
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The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
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After 6 to 8 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical fitness and mobility
Time Frame: Monthly visits for 6 to 8 months of treatment
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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.
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Monthly visits for 6 to 8 months of treatment
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Psychological Impacts
Time Frame: Monthly visits for 6 to 8 months of treatment
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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.
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Monthly visits for 6 to 8 months of treatment
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Self-reported medication adherence
Time Frame: "Surprise" monthly visits during treatment
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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.
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"Surprise" monthly visits during treatment
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Sputum conversion
Time Frame: At 1, 2, 5, and 6/7 months of treatment
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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.
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At 1, 2, 5, and 6/7 months of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 13, 2012
First Submitted That Met QC Criteria
September 19, 2012
First Posted (Estimate)
September 24, 2012
Study Record Updates
Last Update Posted (Estimate)
March 20, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRD_IRB_2011_03_002
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