Evaluating the Effectiveness of Interactive SMS Reminders on TB Drug Compliance and Treatment
This study is currently recruiting participants.
Verified September 2012 by Interactive Research and Development
Sponsor:
Interactive Research and Development
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Shama Mohammed, Interactive Research and Development
ClinicalTrials.gov Identifier:
NCT01690754
First received: September 13, 2012
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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 | Intervention |
|---|---|
|
Tuberculosis |
Other: Interactive Reminders |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Monitoring Patient Compliance With Tuberculosis Treatment Regimens |
Resource links provided by NLM:
Further study details as provided by Interactive Research and Development:
Primary Outcome Measures:
- Treatment Outcomes [ Time Frame: After 6 to 8 months of treatment ] [ Designated as safety issue: No ]The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
- Sputum conversion [ Time Frame: At 2, 5, and 6/7 months of treatment ] [ Designated as safety issue: No ]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.
- Treatment compliance [ Time Frame: Monthly visits for 6 to 8 months of treatment ] [ Designated as safety issue: No ]The regularity of treatment will be measured using urinalysis tests that detect the presence of isoniazid or rifampacin, a first line drug for TB treatment, in patients' urine. These results will be collected through monthly "surprise" visits to the participants' houses. The number of negative results will be compared between treatment and control groups.
Secondary Outcome Measures:
- Physical fitness and mobility [ Time Frame: Monthly visits for 6 to 8 months of treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Treatment Compliance [ Time Frame: Monthly visits for 6 to 8 months of treatment ] [ Designated as safety issue: No ]The regularity of treatment will be measured using urinalysis tests that detect the presence of isoniazid or rifampacin, a first line drug for TB treatment, in patients' urine. These results will be collected through monthly "surprise" visits to the participants' houses.
| Estimated Enrollment: | 2200 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690754
Contacts
| Contact: Shama Mohammed, MPA/ID | shama.mohammed@irdresearch.org |
Locations
| Pakistan | |
| Indus Hospital | Recruiting |
| Karachi, Pakistan | |
| Sindh Government Hospital - New Karachi | Recruiting |
| Karachi, Pakistan | |
| Jinnah Postgraduate Medical Center | Recruiting |
| Karachi, Pakistan | |
| Urban Health Center | Recruiting |
| Karachi, Pakistan | |
Sponsors and Collaborators
Interactive Research and Development
Massachusetts Institute of Technology
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 |
More Information
No publications provided
| Responsible Party: | Shama Mohammed, Director, Community Outreach, Interactive Research and Development |
| ClinicalTrials.gov Identifier: | NCT01690754 History of Changes |
| Other Study ID Numbers: | IRD_IRB_2011_03_002 |
| Study First Received: | September 13, 2012 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Pakistan: Ministry of Health |
Keywords provided by Interactive Research and Development:
|
SMS tuberculosis impact evaluation |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013