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Completed

NCT Number: NCT01690754

Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital, Karachi, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive Reminders

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Interactive Research and Development

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Official study title

Monitoring Patient Compliance With Tuberculosis Treatment Regimens

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2012
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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