Evaluating the Effectiveness of Interactive SMS Reminders on TB Drug Compliance and Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Interactive Research and Development
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: September 19, 2012
Last verified: September 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014