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

Status

Completed

Conditions

Intervention / Treatment

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

  • Pakistan
      • Karachi, Pakistan
        • Indus Hospital
      • Karachi, Pakistan
        • Civil Hospital
      • Karachi, Pakistan
        • Jinnah Postgraduate Medical Center
      • Karachi, Pakistan
        • Landhi Medical Complex
      • Karachi, Pakistan
        • Private GP clinics and Private labs partnering with Interactive Research and Devellopment
      • Karachi, Pakistan
        • Sindh Government Hospital - Liaqatabad
      • Karachi, Pakistan
        • Sindh Government Hospital - New Karachi
      • Karachi, Pakistan
        • Sindh Government Hospital - Qatar
      • Karachi, Pakistan
        • Sindh Government Hospital New Karachi Kaali Market
      • Karachi, Pakistan
        • UHC-New Karachi
      • Karachi, Pakistan
        • Urban Health Center - Landhi

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 6 to 8 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Monthly visits for 6 to 8 months of treatment
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.
Monthly visits for 6 to 8 months of treatment
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.
"Surprise" monthly visits during treatment
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.
At 1, 2, 5, and 6/7 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Interactive Research and Development

Collaborators

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

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.

General Publications

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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