Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

Tuberculosis Clinical Trial

Official title:

Monitoring Patient Compliance With Tuberculosis Treatment Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690754
• Other study ID #: IRD_IRB_2011_03_002
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: March 18, 2015
• Start date: March 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Interactive Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2207
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Karachi
Pakistan	Indus 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	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
Interactive Research and Development	Massachusetts Institute of Technology

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Outcomes	The investigators will compare clinically reported treatment outcomes between the intervention and control groups.	After 6 to 8 months of treatment	No
Secondary	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.	Monthly visits for 6 to 8 months of treatment	No
Secondary	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.	Monthly visits for 6 to 8 months of treatment	No
Secondary	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.	"Surprise" monthly visits during treatment	No
Secondary	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.	At 1, 2, 5, and 6/7 months of treatment	No