Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

This study has been completed.
Sponsor:
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: March 18, 2015
Last verified: March 2015

September 13, 2012
March 18, 2015
March 2011
November 2014   (final data collection date for primary outcome measure)
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.
  • 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.
Complete list of historical versions of study NCT01690754 on ClinicalTrials.gov Archive Site
  • 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.
  • Self-reported medication adherence [ Time Frame: "Surprise" monthly visits during treatment ] [ Designated as safety issue: No ]
    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 ] [ 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.
  • 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.
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Not Provided
 
Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Tuberculosis
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.
  • 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.
    Intervention: Other: Interactive Reminders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2207
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01690754
IRD_IRB_2011_03_002
No
Not Provided
Not Provided
Shama Mohammed, Interactive Research and Development
Interactive Research and Development
Massachusetts Institute of Technology
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
Interactive Research and Development
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP