Clinical trial NCT01690754: Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
Official title: Monitoring Patient Compliance With Tuberculosis Treatment Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: SMS
tuberculosis
impact evaluation
Lead sponsor: Interactive Research and Development
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2012-09-24
Enrollment: 2207
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Treatment Outcomes
timeFrame: After 6 to 8 months of treatment
Secondary outcomes:
measure: Physical fitness and mobility
timeFrame: Monthly visits for 6 to 8 months of treatment
measure: Psychological Impacts
timeFrame: Monthly visits for 6 to 8 months of treatment
measure: Self-reported medication adherence
timeFrame: "Surprise" monthly visits during treatment
measure: Sputum conversion
timeFrame: At 1, 2, 5, and 6/7 months of treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital
city: Karachi
country: Pakistan
facility: Indus Hospital
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Center
city: Karachi
country: Pakistan
facility: Landhi Medical Complex
city: Karachi
country: Pakistan
facility: Private GP clinics and Private labs partnering with Interactive Research and Devellopment
city: Karachi
country: Pakistan
facility: Sindh Government Hospital - Liaqatabad
city: Karachi
country: Pakistan
facility: Sindh Government Hospital - New Karachi
city: Karachi
country: Pakistan
facility: Sindh Government Hospital - Qatar
city: Karachi
country: Pakistan
facility: Sindh Government Hospital New Karachi Kaali Market
city: Karachi
country: Pakistan
facility: UHC-New Karachi
city: Karachi
country: Pakistan
facility: Urban Health Center - Landhi
Study officials:
affiliation: Massachusetts Institute of Technology
name: Rachel Glennerster, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Interactive Research and Development
name: Shama Mohammed, MPA/ID
role: PRINCIPAL_INVESTIGATOR
affiliation: Interactive Research and Development
name: Aamir J. Khan, MD/PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.