NCT01690754

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

September 13, 2012

Last Update Submit

March 18, 2015

Conditions

Keywords

SMStuberculosisimpact evaluation

Outcome Measures

Primary Outcomes (1)

  • Treatment Outcomes

    The investigators will compare clinically reported treatment outcomes between the intervention and control groups.

    After 6 to 8 months of treatment

Secondary Outcomes (4)

  • Physical fitness and mobility

    Monthly visits for 6 to 8 months of treatment

  • Psychological Impacts

    Monthly visits for 6 to 8 months of treatment

  • Self-reported medication adherence

    "Surprise" monthly visits during treatment

  • Sputum conversion

    At 1, 2, 5, and 6/7 months of treatment

Study Arms (2)

Control

NO INTERVENTION

This arm will receive the regular standard of care given by TB clinics.

Interactive Reminders

EXPERIMENTAL

Patients randomized to this arm will receive Interactive SMS reminders daily.

Other: Interactive Reminders

Interventions

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.

Interactive Reminders

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Civil Hospital

Karachi, Pakistan

Location

Indus Hospital

Karachi, Pakistan

Location

Jinnah Postgraduate Medical Center

Karachi, Pakistan

Location

Landhi Medical Complex

Karachi, Pakistan

Location

Private GP clinics and Private labs partnering with Interactive Research and Devellopment

Karachi, Pakistan

Location

Sindh Government Hospital - Liaqatabad

Karachi, Pakistan

Location

Sindh Government Hospital - New Karachi

Karachi, Pakistan

Location

Sindh Government Hospital - Qatar

Karachi, Pakistan

Location

Sindh Government Hospital New Karachi Kaali Market

Karachi, Pakistan

Location

UHC-New Karachi

Karachi, Pakistan

Location

Urban Health Center - Landhi

Karachi, Pakistan

Location

Related Publications (1)

  • Mohammed S, Glennerster R, Khan AJ. Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial. PLoS One. 2016 Nov 1;11(11):e0162944. doi: 10.1371/journal.pone.0162944. eCollection 2016.

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Researcher

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 24, 2012

Study Start

March 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations