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Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Interactive Reminders
Sponsored by
Interactive Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tuberculosis focused on measuring SMS, tuberculosis, impact evaluation

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Interactive Reminders

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical fitness and mobility
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
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
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
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.

Full Information

First Posted
September 13, 2012
Last Updated
March 18, 2015
Sponsor
Interactive Research and Development
Collaborators
Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01690754
Brief Title
Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
Official Title
Monitoring Patient Compliance With Tuberculosis Treatment Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Interactive Research and Development
Collaborators
Massachusetts Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
SMS, tuberculosis, impact evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will receive the regular standard of care given by TB clinics.
Arm Title
Interactive Reminders
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive Interactive SMS reminders daily.
Intervention Type
Other
Intervention Name(s)
Interactive Reminders
Intervention Description
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 Outcome Measure Information:
Title
Treatment Outcomes
Description
The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
Time Frame
After 6 to 8 months of treatment
Secondary Outcome Measure Information:
Title
Physical fitness and mobility
Description
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.
Time Frame
Monthly visits for 6 to 8 months of treatment
Title
Psychological Impacts
Description
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.
Time Frame
Monthly visits for 6 to 8 months of treatment
Title
Self-reported medication adherence
Description
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.
Time Frame
"Surprise" monthly visits during treatment
Title
Sputum conversion
Description
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.
Time Frame
At 1, 2, 5, and 6/7 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Glennerster, PhD.
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shama Mohammed, MPA/ID
Organizational Affiliation
Interactive Research and Development
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aamir J. Khan, MD/PhD.
Organizational Affiliation
Interactive Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Civil Hospital
City
Karachi
Country
Pakistan
Facility Name
Indus Hospital
City
Karachi
Country
Pakistan
Facility Name
Jinnah Postgraduate Medical Center
City
Karachi
Country
Pakistan
Facility Name
Landhi Medical Complex
City
Karachi
Country
Pakistan
Facility Name
Private GP clinics and Private labs partnering with Interactive Research and Devellopment
City
Karachi
Country
Pakistan
Facility Name
Sindh Government Hospital - Liaqatabad
City
Karachi
Country
Pakistan
Facility Name
Sindh Government Hospital - New Karachi
City
Karachi
Country
Pakistan
Facility Name
Sindh Government Hospital - Qatar
City
Karachi
Country
Pakistan
Facility Name
Sindh Government Hospital New Karachi Kaali Market
City
Karachi
Country
Pakistan
Facility Name
UHC-New Karachi
City
Karachi
Country
Pakistan
Facility Name
Urban Health Center - Landhi
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27802283
Citation
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.
Results Reference
derived

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Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

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